Breast Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Urinary Bladder Neoplasms
Conditions
Keywords
Imaging, Radiopharmaceutical, Safety, Dosimetry, Drug Distribution, Cancer
Brief summary
Background: \- The drugs FdCyd (also called 5-fluoro-2'-deoxycytidine) and THU (also called tetrahydrouridine) are being used in a cancer treatment study. Not a lot is known about how FdCyd works in the body. Researchers want to look at a modified form of FdCyd using imaging studies to see how the drug reacts with the cancer. This study is not a treatment study. It is open only to people who are already on the FdCyd and THU cancer treatment study. Objectives: \- To study how FdCyd affects advanced cancer cells. Eligibility: \- Participants in National Cancer Institute study 09-C-0214. Design: * Participants will have two imaging studies, one before starting FdCyd and THU treatment and one after starting treatment. * Participants will have the modified FdCyd, known as F-18 FdCyd, with a dose of THU. The doses will be followed by two imaging study scans and frequent blood samples. * This procedure will be repeated at a later date, during the FdCyd and THU treatment period. * Treatment will not be provided as part of this study. This is an imaging study protocol only....
Detailed description
BACKGROUND: \- In pre-clinical models, 5-fluoro-2-deoxycytidine (FdCyd), administered along with tetrahydrouridine (THU; an inhibitor of cytidine/deoxycytidine deaminase), has shown superior anti-tumor activity as compared with 5-fluorouracil. \- FdCyd can be phosphorylated to 5-fluoro-2-deoxycytidylate (FdCMP) by deoxycytidine kinase and the nucleotide deaminated to FdUMP by deoxycytidylate (dCMP) deaminase. The activity of dCMP deaminase is reported to be higher in human malignancies than in normal tissues, which may result in selective cytotoxicity. * FdCyd is an inhibitor of deoxyribonucleic acid (DNA) methyltransferase and DNA methylation, resulting in reexpression of genes silenced by DNA hypermethylation. It is being evaluated in a phase II multihistology clinical trial at the Developmental Therapeutics Clinic, National Cancer Institute (NCI), Clinical Center, National Institutes of Health (NIH). * While FdCyd + THU has shown preliminary evidence of activity in early phase trials not all patients show clinical response. The establishment of a radiolabeled form to image the biodistribution in vivo at baseline and during therapy may provide insight into the distribution of the therapeutic drug. * The first step in the development of such an in vivo marker is to determine the biodistribution and safety of the radiolabeled form. OBJECTIVES: * Determine the safety of \[F-18\]-5-fluoro-2'-deoxycytidine (FdCyd) administered intravenously with administration of tetrahydrouridine (THU). * Estimate the radiation dosimetry of \[F-18\]-FdCyd in humans. ELIGIBILITY: * Only patients enrolled in NCI Phase II Study evaluating FdCyd with THU (NCI Protocol # 09-C-0214 (CTEP# 8351) or NCI Protocol #12-C-0066 (CTEP# 9127)) at the NIH Clinical Center will be eligible to participate in this study). * Patients must have a target lesion greater than or equal to 10mm * May not be pregnant or lactating; must be less than or equal to 350 lbs; and may not have known allergy to FdCyd or contraindications to positron emission tomography (PET)/computed tomography (CT) imaging. DESIGN: * There are two arms to this study * The first arm will be patients enrolling in the therapeutic Phase II 5-FdCyd/THU study (NCI Protocol # 09-C-0214 (CTEP# 8351) in the NCI Developmental Therapeutics Clinic * The second arm will be patients enrolling in the Phase I 5-FdCyd/THU study (NCI Protocol #12-C-0066 (CTEP# 9127)) in the NCI Developmental Therapeutics Clinic. * Patients will undergo an initial \[F-18\]-FdCyd + THU PET/CT imaging prior to therapeutic dosing on study NCI Protocol # 09-C-0214 (CTEP# 8351) or NCI Protocol #12-C-0066 (CTEP# 9127). Repeat imaging will be performed while the patient is receiving FdCyd + THU therapy under the parent therapeutic protocol. This imaging must be completed 2-5 days after cycle start and at least 2 hours after a dose. Upon completion of repeat imaging, patients will be taken off this imaging study 24 hours after the last imaging session.
Interventions
DRUG[F-18]-5-FLUORO-2'-DEOXYCYTIDINE
18FdCyd radiotracer
DRUGTetrahydrouridine intravenous (IV)
Total dose of THU = 350 mg/m\^2, IV
DRUGTetrahydrouridine (oral)
Total dose of THU is 3000 mg, oral
DIAGNOSTIC_TESTPositron emission tomography (PET)/Computed tomography (CT)
One prior CT and 3 sequential whole body PET
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: * Enrolled in the National Institutes of Health (NIH) Phase II Clinical protocol evaluating 5-fluro-2'-deoxycytidine (FdCyd) with Tetrahydrouridine (THU) (09-C-0214) with target lesion measured as greater than or equal to 10mm with spiral computed tomography (CT) scan. * Written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines * For females: Negative serum pregnancy test OR post-menopausal for at least 2 years OR patient has had a hysterectomy
Exclusion criteria
* Participants with severe claustrophobia unresponsive to oral anxiolytics * Subjects weighing \> 400 lbs (weight limit for scanner table), or unable to fit within the imaging gantry * Known allergy to FdCyd * The subject is unable to lie still for 75 minutes * 5 Pregnant or lactating women. Pregnant women are excluded from this study because the effects of 18F-FdCyd in pregnancy are not known. Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 18F-FdCyd in the mother, breastfeeding should be discontinued if the mother receives 18F-FdCyd * Participants with any co-existing medical or psychiatric condition that is likely to interfere with study procedures and/or results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and Severity of Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | Within 5 days after interventions | \[F-18\]-5-fluoro-2'-deoxycytidine (FdCyd) was administered intravenously with administration of tetrahydrouridine (THU) and the frequency and severity of adverse events was observed. 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. Grade 0 is normal, Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe or medically significant but not immediately life-threatening, Grade 4 is life-threatening consequences, and Grade 5 is death related to adverse event. |
| Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | 1 year | Radiation dosimetry was determined based on the first patients. This involved making region of interest measurements on the scan for each major organ and measuring the uptake. Using standard dosimetry software this is converted into mSv/MBq, a standard measure of dosimetry. The software is known as Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA) and is commonly used to generate this kind of data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | 9 minutes, 32 minutes, 56 minutes and 2 hours after injection | Participants were scanned by positron emission tomography (PET) and lesions were measured at 4 time points after injection. |
| Number of Participants With Serious and Non-Serious Adverse Events | Date treatment consent signed to date off study, approximately 20 months and 12 days. | Here is the number of participants with serious and 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
Pre-assignment details
No participants were enrolled in the 2/Oral Tetrahydrouridine (THU) Group.
Participants by arm
| Arm | Count |
|---|---|
| 1/Intravenous (IV) Tetrahydrouridine (THU) \[F-18\]-5-fluoro-2'-deoxycytidine plus Tetrahydrouridine
\[F-18\]-5-FLUORO-2'-DEOXYCYTIDINE: 18FdCyd radiotracer
Tetrahydrouridine intravenous (IV): Total dose of Tetrahydrouridine (THU) = 350 mg/m\^2, IV
Tetrahydrouridine (oral): Total dose of THU is 3000 mg, oral
Positron emission tomography (PET)/Computed tomography (CT): One prior CT and 3 sequential whole body PET | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | 1/Intravenous (IV) Tetrahydrouridine (THU) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 55.46 years STANDARD_DEVIATION 15.19 |
| Baseline Tumor Types Head & Neck Carcinoma | 2 Participants |
| Baseline Tumor Types Hepatocellular Carcinoma | 1 Participants |
| Baseline Tumor Types Non-Small Cell Lung Carcinoma | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 5 |
| other Total, other adverse events | 2 / 5 |
| serious Total, serious adverse events | 2 / 5 |
Outcome results
Primary
Frequency and Severity of Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
\[F-18\]-5-fluoro-2'-deoxycytidine (FdCyd) was administered intravenously with administration of tetrahydrouridine (THU) and the frequency and severity of adverse events was observed. 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. Grade 0 is normal, Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe or medically significant but not immediately life-threatening, Grade 4 is life-threatening consequences, and Grade 5 is death related to adverse event.
Time frame: Within 5 days after interventions
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Frequency and Severity of Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | Day 1 Adverse Events | 0 adverse events |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Frequency and Severity of Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | Day 2, Grade 2 Hypoalbuminemia | 1 adverse events |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Frequency and Severity of Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | Day 2, Grade 3 Anemia | 1 adverse events |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Frequency and Severity of Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | Day 3 Adverse Events | 0 adverse events |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Frequency and Severity of Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | Day 4 Adverse Events | 0 adverse events |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Frequency and Severity of Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | Day 5 Adverse Events | 0 adverse events |
Primary
Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans
Radiation dosimetry was determined based on the first patients. This involved making region of interest measurements on the scan for each major organ and measuring the uptake. Using standard dosimetry software this is converted into mSv/MBq, a standard measure of dosimetry. The software is known as Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA) and is commonly used to generate this kind of data.
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Adrenals | 1.83 mSv/MBq | Standard Deviation 9.3 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Brain | 8.17 mSv/MBq | Standard Deviation 2.04 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Breasts | 1.03 mSv/MBq | Standard Deviation 1.01 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Gallbladder wall | 4.05 mSv/MBq | Standard Deviation 7.55 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Lower large intestine wall | 2.52 mSv/MBq | Standard Deviation 7.82 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Small intestine | 2.13 mSv/MBq | Standard Deviation 4.57 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Stomach wall | 1.90 mSv/MBq | Standard Deviation 3.27 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Upper large intestine wall | 2.04 mSv/MBq | Standard Deviation 6.43 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Heart wall | 1.10 mSv/MBq | Standard Deviation 1.82 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Kidneys | 5.26 mSv/MBq | Standard Deviation 2.23 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Liver | 6.02 mSv/MBq | Standard Deviation 2.74 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Lungs | 1.82 mSv/MBq | Standard Deviation 7.1 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Muscle | 1.16 mSv/MBq | Standard Deviation 1.35 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Ovaries | 1.57 mSv/MBq | Standard Deviation 2.22 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Pancreas | 1.63 mSv/MBq | Standard Deviation 4.27 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Red marrow | 1.14 mSv/MBq | Standard Deviation 2.19 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Osteogenic cells | 1.71 mSv/MBq | Standard Deviation 6.41 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Skin | 8.65 mSv/MBq | Standard Deviation 1.19 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Spleen | 1.69 mSv/MBq | Standard Deviation 5.55 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Testes | 1.03 mSv/MBq | Standard Deviation 2.38 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Thymus | 1.12 mSv/MBq | Standard Deviation 3.01 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Thyroid | 8.23 mSv/MBq | Standard Deviation 4.39 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Urinary bladder wall | 7.96 mSv/MBq | Standard Deviation 5.24 |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Radiation Dosimetry Estimates of 5-fluoro-2'-Deoxycytidine (FdCyd) in Humans | Uterus | 1.63 mSv/MBq | Standard Deviation 4.99 |
Secondary
Number of Participants With Serious and Non-Serious Adverse Events
Here is the number of participants with serious and 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 20 months and 12 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Number of Participants With Serious and Non-Serious Adverse Events | 2 Participants |
Secondary
Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection
Participants were scanned by positron emission tomography (PET) and lesions were measured at 4 time points after injection.
Time frame: 9 minutes, 32 minutes, 56 minutes and 2 hours after injection
Population: One participant contributed to data in each row.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 3 Non-small Cell Lung Ca at 56 min | 1.5 TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 1 L. Parotid adenosquam. cell ca at 9 min | 1.4 TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 1 L. Parotid adenosquam. cell ca at 32 min | 1.5 TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 1 L. Parotid adenosquam. cell ca at 56 min | 1.5 TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 1 L. Parotid adenosquam. cell ca at 2 hrs | 1.6 TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 2 R. Parapharyngeal Spindle Cell Ca at 9 min | 1.9 TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 2 R. Parapharyngeal Spindle Cell Ca at 32 min | 1.7 TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 2 R. Parapharyngeal Spindle Cell Ca at 56 min | 1.7 TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 2 R. Parapharyngeal Spindle Cell Ca at 2 hrs | 1.6 TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 3 Non-small Cell Lung Ca at 9 min | 1.4 TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 3 Non-small Cell Lung Ca at 32 min | 1.4 TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 3 Non-small Cell Lung Ca at 2 hrs | 1.7 TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 4 Non-small Cell Lung Ca at 9 min | 2.4 TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 4 Non-small Cell Lung Ca at 32 min | 2.1 TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 4 Non-small Cell Lung Ca at 56 min | 1.6 TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 4 Non-small Cell Lung Ca at 2 hrs | 2.0 TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 5 Hepatocellular Ca at 9 min | NA TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 5 Hepatocellular Ca at 32 min | NA TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 5 Hepatocellular Ca at 56 min | NA TBR ratio |
| 1/Intravenous (IV) Tetrahydrouridine (THU) | Tumor to Background Ratios (TBRs) of Target Lesions at 4 Time Points After Injection | Pt 5 Hepatocellular Ca at 2 hrs | NA TBR ratio |