Lymphoma
Conditions
Keywords
18F-Fluorothymidine, PET/CT, FLT, Lymphoma, FDG
Brief summary
Background: * Positron emission tomography (PET) uses radioactive substances called radiotracers to locate areas of cancer in the body. For this test, the patient is given an injection of the radiotracer and lies in a large donut-shaped scanner that detects where in the body the radioactivity accumulates. Computed tomography (CT) scans use low dose x-rays that help to better localize where the radioactive tracer is concentrating. PET/CT scans are usually done in lymphoma patients before treatment starts and at the end of treatment to evaluate the response to therapy. * PET scans typically use a sugar-like radioactive tracer called fluorodeoxyglucose (FDG) and low-dose x-rays. Sometimes, however, FDG PET scans show what looks like active disease and presence of a mass after chemotherapy even when there are no live cancer cells. Doctors have particular problems in evaluating response to treatment when this happens because they can't tell if the mass is active cancer or just dead tumor cells. * An experimental radiotracer called 18F- Fluorothymidine (FLT) has high uptake in active tumor cells and may be better able to evaluate treatment response. Objectives: \- To test the use of FLT PET/CT imaging in assessing treatment response in patients with lymphoma. Eligibility: \- Patients 18 years of age or older who are enrolled in a lymphoma therapy study at the National Institutes of Health (NIH) Clinical Center or in the Cancer and Leukemia Group B (CALGB) 50330 study at another location. Design: \- There are two arms in this study: * The first arm evaluates FLT as an early predictor of tumor response to therapy. Patients are imaged with FLT and FDG PET before starting treatment, following two cycles of therapy and after treatment ends. * The second arm evaluates the ability of FLT to distinguish if a mass that remains after treatment has viable cancer or dead tissue. Patients who have completed treatment and in whom FDG PET shows a remaining tumor mass are imaged with FLT PET. Following the scan, the tumor is biopsied for verification.
Detailed description
Background: * 3-deoxy-3-18F-fluorothymidine (FLT) positron emission tomography (FLT PET)/Compute tomography (CT) has been shown to correlate with the rate of cellular/tumor proliferation. * The Imaging Subcommittee of the International Harmonization Project in Lymphoma recommends performing fluorodeoxyglucose (FDG) positron emission tomography (PET) at least 3 weeks, and preferably 6-8 weeks after chemotherapy or chemoimmunotherapy and 8-12 weeks after radiation or chemoradiation therapy due to high FDG accumulation in inflammatory tissues. * FLT uptake in inflammatory lesions is less prominent than FDG and it is likely that FLT PET/CT can better differentiate inflammation from tumor. * FLT PET/CT imaging is expected to better differentiate between treatment induced inflammation and malignancy and should enable early prediction of therapeutic response. * FLT PET/CT imaging is expected to differentiate between residual inflammatory residual masses from residual malignancy and therefore guide appropriate treatment. Primary Objectives: * To estimate the diagnostic accuracy of FLT PET/CT as an early indicator of complete response to therapy in B and T cell lymphoma. * To estimate the diagnostic accuracy of FLT PET/CT in the evaluation of residual masses after therapy. Eligibility: * Participant must be enrolled in a lymphoma therapy study at the National Institutes of Health (NIH) Clinical Center OR be enrolled in the CALGB 50303 study at another site OR undergoing a new course of treatment of lymphoma at another facility. The National Cancer Institute (NCI) Laboratory of Pathology will confirm diagnosis for subjects enrolled at all CALGB study sites. * Participants must have a clinical course consistent with lymphoma and have available documentation of lymphoma from either the NCI or from an outside pathology laboratory. * Subjects enrolling in the early response arm must undergo baseline FLT PET prior to receiving a new course of lymphoma therapy. * Subjects enrolling in the residual mass evaluation arm can be enrolled at the time the FDG avid residual mass is discovered (i.e. no pre-therapy FLT image is required). * Subjects can enroll in both arms of the study. * Participant must be 18 years or older. * Eastern Cooperative Oncology Group (ECOG) Performance score of 0 or 1. * Serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) less than 5 times upper limit of normal (ULN). * bilirubin less than or equal to 2 times ULN. Design: There are 2 arms in this study * The first arm will assess FLT as an early predictor of tumor response to therapy (treatment naive or recurrent disease). Subjects are imaged with FLT and FDG PET pre-therapy, following 2 cycles of therapy and post therapy. * The second arm will assess lymphoma patients with FDG PET positive residual mass. Subjects are imaged with FLT PET prior to standard of care biopsy of residual mass. If initial FDG PET data is not available in Digital Imaging and Communications in Medicine (DICOM) format or is of suboptimal image quality, a repeat FDG PET/CT at the study site may be required. * We will accrue 70 participants (40 in the early response arm and 30 in the residual mass arm) to this study.
Interventions
PROCEDUREBiopsy
Biopsy taken
DIAGNOSTIC_TESTfluorodeoxyglucose F 18 Positron Emission Tomography and computed tomography
Imaging
OTHER[3'-deoxy-3'-[F-18] fluorothymidine
Undergo scans
PROCEDUREcomputed tomography
Undergo scans
PROCEDUREfine-needle aspiration
sample collected
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: Participant must be enrolled in a lymphoma therapy study at the National Institutes of Health (NIH) Clinical Center OR be enrolled in the Cancer and Leukemia Group B (CALGB) 50303 study at another site OR undergoing a new course of treatment of lymphoma at another facility. Participants must have a clinical course consistent with lymphoma and have available documentation of lymphoma from either the National Cancer Institute (NCI) or from an outside pathology laboratory. Participant must be 18 years or older. Eastern Cooperative Oncology Group (ECOG) Performance score of 0 or 1. Ability to provide informed consent. All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed. For subjects enrolling in early response arm * Must be enrolled in CALGB 50303 or a lymphoma therapy study at the NIH Clinical Center or undergoing a new course of treatment of lymphoma at another facility * Must not have begun lymphoma therapy for this tumor occurrence/ relapse * Prior completed therapy does NOT affect eligibility For subjects enrolling in the residual FDG avid mass arm * Must have a residual (18)F-fluorodeoxyglucose (FDG) positron emission tomography (PET) positive mass greater than equal to 1cm, with uptake greater than that of mediastinal blood pool. * Participant will undergo a repeat FDG PET/CT scan if the original FDG/PET imaging performed at an outside institution is not of adequate imaging quality for subjects enrolling in the residual FDG mass arm.
Exclusion criteria
Known allergy to fluorothymidine. Participants for whom enrollment would significantly delay (greater than 2 weeks) the scheduled standard of care therapy. Participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results are excluded. Participants with severe claustrophobia not relieved by oral anxiolytic medication or patients weighing greater than 136 kg (weight limit for scanner table). Other medical conditions deemed by the Principal Investigator (PI) or associates to make the patient ineligible for protocol procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Presence/Absence of Abnormal 18F- Fluorothymidine (FLT) Uptake, and Positive/Negative Biopsy | Up to 3.5 years | A positive malignant residual mass was defined as focal 18F- Fluorothymidine (FLT) uptake within the residual mass greater than the normal mediastinal background uptake. FLT uptake within the mass lower than the mediastinal was considered non-malignant. The positive/negative FLT uptake was correlated with biopsy results within the residual mass (presence or absence of malignant tumor cells). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 18F- Fluorothymidine (FLT) Uptake Within the Tumor(s) Between Baseline vs Completion of Therapy Scans | up to 4.5 years | FLT uptake within the tumor(s) using standard uptake value (SUVmax) was compared between baseline and completion of therapy scans. |
| Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline Scan and SUVmax After Completion Scan in Responders and Non-responders' Patients | up to 4.5 years | The SUVmax (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s). SUVmax was calculated at baseline and after completion of therapy. |
| 18F- Fluorothymidine (FLT) Uptake, Positron-emission Tomography (PET) Standard Uptake Value (SUV)Max in Malignant Residual Tumors Versus Benign Lesions After Therapy | up to 4.5 years | FLT uptake was calculated within malignant residual tumors versus benign lesions using maximum standard uptake value (SUVmax). |
| Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) | Up to 4.5 years | The maximum standard uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s). |
| 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | up to 3.5 years | The maximum uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was calculated within the residual mass at 1 h and at 2 hours post-injection of FLT. |
| Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline and at Mid-treatment (Post-2 Cycles) Scan | Up to 4.5 years | The SUVmax (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s). SUVmax was calculated at baseline and after 2-cycles of therapy. |
| Time to Progression | up to 4.5 years | The time to progression (defined as time in months from 3'-deoxy-3'-\[18F\] fluorothymidine (FLT)-scan until patient progressed) was compared between the two groups (patients with higher Maximum Standard Uptake Value (SUVmax) vs lower SUVmax, using the median SUV value). |
| 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | up to 3.5 years | After 1 hour post-injection of fluorodeoxyglucose (FDG), the maximum uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was calculated was calculated within the residual mass. The ratio between SUVmax within the residual mass and SUVmean in the pool blood was measured. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 4 years, 7 months and 9 days. | Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants Scanned at Baseline & After Chemotherapy Patients undergo 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B.
Fluorodeoxyglucose F 18: Undergo scans \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans | 9 |
| Participants Scanned in the Evaluation of Residual Masses After Therapy Patients undergo a 3'-deoxy-3'-\[18F\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.
Biopsy: Biopsy taken \[3'-deoxy-3'-\[F-18\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected | 22 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| After 2 Cycles | Participant refused to be scanned further | 1 | 0 |
| After Completion | Participant missed scan appointment | 1 | 0 |
| Baseline | Drug not synthesize dose | 1 | 0 |
| Baseline | Not treated-ineligible per CT | 0 | 1 |
Baseline characteristics
| Characteristic | Participants Scanned in the Evaluation of Residual Masses After Therapy | Participants Scanned at Baseline & After Chemotherapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 8 Participants | 26 Participants |
| Age, Continuous | 48.0 years STANDARD_DEVIATION 17.3 | 49.3 years STANDARD_DEVIATION 13 | 48.4 years STANDARD_DEVIATION 16.1 |
| Diagnosis Hodgkin's Lymphoma | 5 participants | 3 participants | 8 participants |
| Diagnosis Non-Hodgkin's Lymphoma | 17 participants | 6 participants | 23 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 9 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 9 Participants | 26 Participants |
| Region of Enrollment United States | 22 participants | 9 participants | 31 participants |
| Residual Mass Size Patient 10-Right pelvic mass | 2.2 cm | — | 2.2 cm |
| Residual Mass Size Patient 11-Right paratracheal lymph node | 2.0 cm | — | 2.2 cm |
| Residual Mass Size Patient 12-Left inguinal lymph node | 1.6 cm | — | 1.6 cm |
| Residual Mass Size Patient 13-Left axilla lymph node | 3.0 cm | — | 3.0 cm |
| Residual Mass Size Patient 14-Gastrohepatic lymph node | 2.8 cm | — | 2.8 cm |
| Residual Mass Size Patient 15-Right posterior thigh mass | 2.5 cm | — | 2.5 cm |
| Residual Mass Size Patient 16-Left abdominal mass | 8.0 cm | — | 8 cm |
| Residual Mass Size Patient 17-Left suprarenal mass | 4.3 cm | — | 4.3 cm |
| Residual Mass Size Patient 18-Splenic mass | 2.3 cm | — | 2.3 cm |
| Residual Mass Size Patient 19-Right paraaortic lymph node | 2.7 cm | — | 2.7 cm |
| Residual Mass Size Patient 1-Right hilum lymph node | 2.4 cm | — | 2.4 cm |
| Residual Mass Size Patient 20-Right hilum lymph node | 1.6 cm | — | 1.6 cm |
| Residual Mass Size Patient 21-Mesenteric mass | 5.2 cm | — | 5.2 cm |
| Residual Mass Size Patient 2-Superior mediastinal lymph node | 2.4 cm | — | 2.4 cm |
| Residual Mass Size Patient 3-Lumbar vertebrae | 2.5 cm | — | 2.5 cm |
| Residual Mass Size Patient 4-Right pelvic mass | 9.0 cm | — | 9.0 cm |
| Residual Mass Size Patient 5-Intercostal soft tissue mass | 2.3 cm | — | 2.3 cm |
| Residual Mass Size Patient 6-Right cervical lymph node | 3.7 cm | — | 3.7 cm |
| Residual Mass Size Patient 7-Anterior mediastinal mass | 2.7 cm | — | 2.7 cm |
| Residual Mass Size Patient 8-Anterior mediastinal mass | 6.8 cm | — | 6.8 cm |
| Residual Mass Size Patient 9-Internal right iliac lymph node | 2.2 cm | — | 2.2 cm |
| Sex: Female, Male Female | 12 Participants | 3 Participants | 15 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 8 | 5 / 21 |
| other Total, other adverse events | 1 / 8 | 1 / 21 |
| serious Total, serious adverse events | 0 / 8 | 0 / 21 |
Outcome results
Primary
Number of Participants With the Presence/Absence of Abnormal 18F- Fluorothymidine (FLT) Uptake, and Positive/Negative Biopsy
A positive malignant residual mass was defined as focal 18F- Fluorothymidine (FLT) uptake within the residual mass greater than the normal mediastinal background uptake. FLT uptake within the mass lower than the mediastinal was considered non-malignant. The positive/negative FLT uptake was correlated with biopsy results within the residual mass (presence or absence of malignant tumor cells).
Time frame: Up to 3.5 years
Population: 21/22 participants were analyzed because one participant was not treated ineligible per CT criteria. Data was collected for only the Arm/Group of participants with residual masses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Number of Participants With the Presence/Absence of Abnormal 18F- Fluorothymidine (FLT) Uptake, and Positive/Negative Biopsy | Presence of FLT uptake | 9 Participants |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Number of Participants With the Presence/Absence of Abnormal 18F- Fluorothymidine (FLT) Uptake, and Positive/Negative Biopsy | Absence of FLT uptake and FLT uptake lower than normal mediastinum | 12 Participants |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Number of Participants With the Presence/Absence of Abnormal 18F- Fluorothymidine (FLT) Uptake, and Positive/Negative Biopsy | Positive Biopsy | 7 Participants |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Number of Participants With the Presence/Absence of Abnormal 18F- Fluorothymidine (FLT) Uptake, and Positive/Negative Biopsy | Negative Biopsy | 4 Participants |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Number of Participants With the Presence/Absence of Abnormal 18F- Fluorothymidine (FLT) Uptake, and Positive/Negative Biopsy | Biopsy not performed | 10 Participants |
p-value: <0.001Wilcoxon signed-rank test
Secondary
18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection
After 1 hour post-injection of fluorodeoxyglucose (FDG), the maximum uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was calculated was calculated within the residual mass. The ratio between SUVmax within the residual mass and SUVmean in the pool blood was measured.
Time frame: up to 3.5 years
Population: 21/22 participants were analyzed because one participant was not treated ineligible per CT criteria. Data collected only from residual mass Group of patients for this Outcome Measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 1 | 4.6 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 2 | 8.4 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 3 | 10.1 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 4 | 3.8 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 5 | 6.9 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 6 | 6.7 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 7 | 5.4 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 8 | 4.7 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 9 | 4.6 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 10 | 10.3 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 11 | 4.8 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 12 | 3.8 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 13 | 4.0 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 14 | 6.9 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 15 | 6.4 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 16 | 15.8 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 17 | 11.2 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 18 | 2.1 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 19 | 3.8 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 20 | 3.5 SUVmax/Tumor blood ratio |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection | Patient 21 | 9.1 SUVmax/Tumor blood ratio |
Secondary
18F- Fluorothymidine (FLT) Uptake, Positron-emission Tomography (PET) Standard Uptake Value (SUV)Max in Malignant Residual Tumors Versus Benign Lesions After Therapy
FLT uptake was calculated within malignant residual tumors versus benign lesions using maximum standard uptake value (SUVmax).
Time frame: up to 4.5 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F- Fluorothymidine (FLT) Uptake, Positron-emission Tomography (PET) Standard Uptake Value (SUV)Max in Malignant Residual Tumors Versus Benign Lesions After Therapy | Benign Lesions | 1.7 SUVmax | Standard Deviation 0.6 |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F- Fluorothymidine (FLT) Uptake, Positron-emission Tomography (PET) Standard Uptake Value (SUV)Max in Malignant Residual Tumors Versus Benign Lesions After Therapy | Malignant Lesions | 5.5 SUVmax | Standard Deviation 2.2 |
Secondary
18F- Fluorothymidine (FLT) Uptake Within the Tumor(s) Between Baseline vs Completion of Therapy Scans
FLT uptake within the tumor(s) using standard uptake value (SUVmax) was compared between baseline and completion of therapy scans.
Time frame: up to 4.5 years
Population: 8/9 participants were analyzed at baseline because the FLT dose failed synthesis in 1 participant. 6/9 participants were analyzed at completion of therapy because 1 participant refused to be imaged, 1 participant missed scan appointment, and 1 patient's FLT dose failed synthesis at baseline and was not scanned at completion of therapy either The rows at baseline and completion of therapy represent the pts: 8 patients were scanned at baseline and 6 pts were scanned at completion of therapy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F- Fluorothymidine (FLT) Uptake Within the Tumor(s) Between Baseline vs Completion of Therapy Scans | Baseline | 9.15 SUVmax | Standard Deviation 2.84 |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 18F- Fluorothymidine (FLT) Uptake Within the Tumor(s) Between Baseline vs Completion of Therapy Scans | Completion of therapy scans | 0.9 SUVmax | Standard Deviation 0.2 |
p-value: 0.0313Wilcoxon matched-pairs signed rank test
Secondary
3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection
The maximum uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was calculated within the residual mass at 1 h and at 2 hours post-injection of FLT.
Time frame: up to 3.5 years
Population: This outcome measure was collected for Arm/Group of patients with residual tumor masses after therapy. 21/22 participants were analyzed in thisArm/Group because one participant was not scanned with FLT, ineligible per CT criteria. 18/21 were analyzed in the second Arm/Group because no scans were available for three participants at 2 hours post injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 12 | 2.2 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 7 | 3.4 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 13 | 7.6 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 3 | 8.9 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 14 | 4.5 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 8 | 1.6 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 15 | 1.9 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 5 | 1.3 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 16 | 3.9 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 9 | 6.5 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 17 | 4.7 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 2 | 2.0 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 18 | 7.9 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 10 | 2.3 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 19 | 1.1 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 6 | 7.5 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 20 | 1.5 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 11 | 2.5 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 21 | 6.4 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 4 | 1.6 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Overall participants | 3.6 SUV | Standard Deviation 2.5 |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 1 | 0.7 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Overall participants | 2.9 SUV | Standard Deviation 2 |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 1 | NA SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 2 | 1.8 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 3 | NA SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 4 | 0.8 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 5 | 7.9 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 6 | 4.6 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 7 | 3.2 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 8 | 1.2 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 9 | 6.0 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 10 | 2.0 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 11 | 2.4 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 12 | 1.5 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 13 | 7.4 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 14 | 4.2 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 15 | 1.6 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 16 | 3.6 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 17 | 4.5 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 18 | 7.9 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 19 | 1.1 SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 20 | NA SUV | — |
| Participants Scanned After Completion of Therapy | 3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection | Patient 21 | 5.4 SUV | — |
Secondary
Time to Progression
The time to progression (defined as time in months from 3'-deoxy-3'-\[18F\] fluorothymidine (FLT)-scan until patient progressed) was compared between the two groups (patients with higher Maximum Standard Uptake Value (SUVmax) vs lower SUVmax, using the median SUV value).
Time frame: up to 4.5 years
Population: 3/6 participants were analyzed because 3 did not progress while on study. Data collected only from the Group of patients scanned at baseline and after chemotherapy for this Outcome Measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Time to Progression | 18.29 Months | Standard Deviation 8 |
Secondary
Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline and at Mid-treatment (Post-2 Cycles) Scan
The SUVmax (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s). SUVmax was calculated at baseline and after 2-cycles of therapy.
Time frame: Up to 4.5 years
Population: 8/9 participants were analyzed because the FLT dose failed synthesis in 1 participant, 1 participant refused to be imaged.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline and at Mid-treatment (Post-2 Cycles) Scan | Baseline | 9.15 SUVmax | Standard Deviation 2.84 |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline and at Mid-treatment (Post-2 Cycles) Scan | 2-cycles post treatment | 1.5 SUVmax | Standard Deviation 0.63 |
Secondary
Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline Scan and SUVmax After Completion Scan in Responders and Non-responders' Patients
The SUVmax (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s). SUVmax was calculated at baseline and after completion of therapy.
Time frame: up to 4.5 years
Population: 8/9 participants were analyzed at baseline and 6/9 were analyzed after completion of therapy because 6 patients completed the 3 scans (baseline, at 2-cycles and after completion of therapy). This outcome measure data is collected only for one of the Arm/Group. The other group of participants were not scanned at baseline and after treatment. This data is for baseline (8 patients) and after therapy (6 patients). The outcome measure refers to baseline and after completion of therapy.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline Scan and SUVmax After Completion Scan in Responders and Non-responders' Patients | Baseline | 9.1 Standard Uptake Value (SUV) - units | Standard Deviation 2.8 |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline Scan and SUVmax After Completion Scan in Responders and Non-responders' Patients | After completion of scan | 1.5 Standard Uptake Value (SUV) - units | Standard Deviation 0.6 |
Secondary
Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax)
The maximum standard uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s).
Time frame: Up to 4.5 years
Population: 6/9 participants were analyzed after completion of therapy because the FLT dose failed synthesis in 1 participant at baseline and was not scanned at completion, 1 participant refused to be imaged and 1 participant missed scan appointment. The other group of participants were not scanned at baseline and after treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) | Patient 3 | 10.3 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) | Patient 5 | 9.3 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) | Patient 2 | 4.8 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) | Patient 6 | 9.2 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) | Patient 4 | 9.1 SUV | — |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) | Group-level (at baseline and after completion of therapy) | 9.2 SUV | Standard Deviation 1.9 |
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) | Patient 1 | 10.9 SUV | — |
| Participants Scanned After Completion of Therapy | Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) | Group-level (at baseline and after completion of therapy) | 0.9 SUV | Standard Deviation 0.2 |
| Participants Scanned After Completion of Therapy | Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) | Patient 1 | 0.9 SUV | — |
| Participants Scanned After Completion of Therapy | Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) | Patient 2 | 1.0 SUV | — |
| Participants Scanned After Completion of Therapy | Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) | Patient 3 | 1.3 SUV | — |
| Participants Scanned After Completion of Therapy | Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) | Patient 4 | 0.9 SUV | — |
| Participants Scanned After Completion of Therapy | Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) | Patient 5 | 0.6 SUV | — |
| Participants Scanned After Completion of Therapy | Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax) | Patient 6 | 0.9 SUV | — |
Other Pre-specified
Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Date treatment consent signed to date off study, approximately 4 years, 7 months and 9 days.
Population: 8/9 patients were injected with the tracer (FLT) and scanned in the first Arm/Group, and 21/22 in the second Arm/Group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Scanned in the Evaluation of Residual Masses After Therapy | Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 7 Participants |
| Participants Scanned After Completion of Therapy | Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 20 Participants |