Cervical Adenocarcinoma, Cervical Adenosquamous Cell Carcinoma, Cervical Small Cell Carcinoma, Cervical Squamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma, Stage I Endometrial Carcinoma, Stage IB Cervical Cancer, Stage II Endometrial Carcinoma, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage III Endometrial Carcinoma, Stage IVA Cervical Cancer
Conditions
Brief summary
This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and radiation therapy in patients with locally advanced cervical cancer or high-risk endometrial cancer. Diagnostic procedures, such as a fludeoxyglucose F 18 positron emission tomography (PET) scan, computed tomography (CT) scan, and ferumoxtran-10 magnetic resonance imaging (MRI) scan, may help find lymph node metastasis in patients with cervical cancer or endometrial cancer.
Detailed description
PRIMARY OBJECTIVES: I. Determine the diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to abdominal (common iliac, para-aortic, and paracaval) lymph nodes in patients with locoregionally advanced cervical carcinoma. II. Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to retroperitoneal abdominal lymph nodes in patients with high-risk endometrial cancer. SECONDARY OBJECTIVES: I. Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to pelvic lymph nodes and pelvic and abdominal lymph nodes combined in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer. II. Compare the additive diagnostic value of CT fusion (PET/CT scan) vs PET scanning alone in identifying metastases to pelvic, abdominal, and combined (all regions) lymph nodes in these patients. III. Compare the diagnostic sensitivity and specificity of PET/CT scanning vs ferumoxtran-10 MRI scanning in identifying metastases to pelvic, abdominal, and combined lymph nodes in these patients. IV. Compare the diagnostic sensitivity and specificity of ferumoxtran-10 MRI vs MRI alone, in terms of size criteria in the abdomen and pelvis, in these patients. V. Determine the percentage of patients with locoregionally advanced cervical cancer or high-risk endometrial cancer who have biopsy-proven disease outside the abdominal or pelvic lymph nodes detected by PET/CT scanning. VI. Determine the accuracy of MRI in determining the depth of myometrial invasion and involvement of cervix in patients with high-risk endometrial cancer. VII. Determine the complications associated with extraperitoneal or laparoscopic abdominal and pelvic lymphadenectomy in patients with locoregionally advanced cervical cancer. VIII. Determine the cause(s) of delay in the initiation of radiotherapy or interruption in radiotherapy in patients with locoregionally advanced cervical cancer. IX. Collect data on the adverse effects of ferumoxtran-10 in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer. X. Compare the size of lymph nodes in pre- and post-ferumoxtran-10 MRI's in a subset of forty patients. OUTLINE: This is a multicenter study. Patients receive fludeoxyglucose F 18 (FDG) IV followed 60 minutes later by positron emission tomography (PET)/CT scanning on day 1. Patients also receive ferumoxtran-10 IV over 30-45 minutes on day 1 (or 24-36 hours before MRI) and undergo MRI on day 2. Patients undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Patients diagnosed with metastatic disease prior to lymph node biopsy proceed directly to primary treatment. Patients with cervical cancer undergo chemoradiotherapy within 4 weeks of PET/CT scan. After completion of study therapy, patients are followed at 6 weeks, 6 months, every 3 months for 2 years, and then every 6 months for 3 years.
Interventions
RADIATIONfludeoxyglucose F 18
Undergo FDG PET/CT
PROCEDUREpositron emission tomography
Undergo FDG PET/CT
PROCEDUREcomputed tomography
Undergo FDG PET/CT
DRUGferumoxtran-10
Undergo femoxtran-10 MRI
PROCEDUREmagnetic resonance imaging
Undergo femoxtran-10 MRI
PROCEDUREdiagnostic lymphadenectomy
Undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy
PROCEDURElymph node biopsy
Undergo pelvic and abdominal lymph node biopsy
Sponsors
NRG Oncology
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed diagnosis of 1 of the following: * Invasive carcinoma of the cervix meeting all of the following criteria: * Previously untreated, primary disease * Locoregionally advanced (stage IB2, IIA \[\>= 4 cm\], or IIB-IVA) disease * Any cell type allowed * High-risk endometrial carcinoma meeting 1 of the following criteria: * Grade 3 endometrioid or non-endometrioid endometrial carcinoma (clear cell or serous papillary) or carcinosarcoma diagnosed from an endometrial biopsy or dilation and curettage or * Grade 1 or 2 endometrioid endometrial carcinoma with cervical stromal involvement overt on clinical examination or confirmed by endocervical curettage * Under consideration for chemoradiotherapy (patients with cervical cancer) * Undergone appropriate surgery for cervical or endometrial carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage * Appropriate surgical candidate to undergo extraperitoneal or laparoscopic lymph node sampling OR hysterectomy and lymph node sampling * No surgery for patients with advanced lymphadenopathy * No recurrent invasive carcinoma of the uterus or uterine cervix regardless of previous treatment * No known metastases to the lungs or scalene lymph nodes * No metastases to other organs outside of the pelvis or abdominal lymph nodes at the time of the original clinical diagnosis * Patients with endometrial cancer with known intraperitoneal disease are eligible provided they undergo pelvic and para-aortic lymphadenectomy per protocol * Participants must be enrolled at an American College of Radiology Imaging Network (ACRIN)-affiliated institution that is accredited by Gynecologic Oncology Group (GOG) * GOG performance status 0-2 * Creatinine within normal institutional limits OR, in participants with creatinine levels above institutional normal, glomerular filtration rate (GFR) must be \> 60 mL/min; there is no lower limit of normal for serum creatinine for this protocol * Ferritin levels =\< 600 ng/mL OR saturation of transferrin level =\< 50% * Patients with high levels of ferritin or transferrin are eligible if documented hematology rules out iron overload * Not pregnant or nursing * Negative pregnancy test * No patients weighing greater than that allowable by the PET/CT scanner * No renal abnormalities, such as a pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of the lymphadenectomy * No history of anaphylactic or life-threatening allergic reactions to any contrast media * No other invasive malignancies within the past 5 years with the exception of nonmelanoma skin cancer * No contraindication to MRI (e.g., severe claustrophobia, pacemaker, aneurysm clips, defibrillators, or other institutional contraindication to MRI) * No history of allergic reactions attributed to compounds of similar chemical or biological composition to ferumoxtran-10 (e.g., iron preparations, parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations) * No immunodeficiencies that would predispose patient to specific or nonspecific mediator release * No history of cirrhosis * No poorly controlled, insulin-dependent diabetes (i.e., fasting blood glucose level \> 200 mg/dL) * No prior pelvic or abdominal lymphadenectomy * No prior pelvic radiotherapy * No prior anticancer therapy that would contraindicate study participation * No ferumoxides within the past 2 weeks * No investigational agents within the past 30 days * No other concurrent investigational agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen | Before surgery (FDG-PET-CT) and after surgery (pathology) | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported sensitivity is reader average sensitivity by seven experienced PET-CT readers. |
| The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen | Before surgery (FDG-PET/CT) and after surgery (pathology) | The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in abdomen. The reported specificity is reader average specificity by seven experienced PET-CT readers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis | Before surgery (FDG-PET/CT) and after surgery (pathology) | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported sensitivity is reader-average sensitivity. |
| The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis | Before surgery (FDG-PET/CT) and after surgery (pathology) | The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported specificity is reader-averaged specificity. |
| Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone | Before surgery (FDG-PET/CT) and after surgery (pathology) | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative CT alone among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers. |
| Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone | Before surgery (FDG-PET/CT) and after surgery (pathology) | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative either CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers. |
| Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone | Before surgery (FDG-PET/CT) and after surgery (pathology) | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative by CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers. |
| Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone | Before surgery (FDG-PET/CT) and after surgery (pathology) | The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers. |
| The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis | Before surgery (DCT) and after surgery (pathology) | The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported sensitivity is reader-averaged sensitivity. |
| Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone | Before surgery (FDG-PET/CT) and after surgery (pathology) | The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers. |
| Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes | Before surgery (FDG-PET/CT) and after surgery (pathology) | — |
| Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node | Before surgery (FDG-PET/CT) and after surgery (pathology) | — |
| Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy | During surgery and up to 30 days after surgery. | Number of participants with cervical cancer and a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0. |
| Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients | Within 4 weeks from PET/CT | Number of cervical cancer patients with reasons of delay in the initiation of chemo-radiation therapy |
| Cause of Interruption in Radiation Therapy in Cervical Cancer Patients | Within 6 weeks after surgery | Number of cervical cancer patients with reasons of interruption in radiation therapy |
| Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone | Before surgery (FDG-PET/CT) and after surgery (pathology) | The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative byCT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers. |
| The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis | Before surgery (FDG-PET/CT) and after surgery (pathology) | The specificity is defined as the percentage of patients who test without lymph node metastases in pelvis by pre-operative PET/CT among the patients who do not have lymph node metastases in pelvis identified by post-surgery pathology. The reported specificity is reader-averaged specificity. |
Countries
Canada, Japan, South Korea, United States
Participant flow
Recruitment details
The study was activated on 9/24/2007. Combidex MRI was discontinued on 11/09/2009 due to lack of study drug. GOG 0233 (NCT 00416455) closed to accrual on 6/21/2013.
Participants by arm
| Arm | Count |
|---|---|
| Cervical Cancer Patients PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 - 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan | 153 |
| Endometrial Cancer Patients PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan | 207 |
| Total | 360 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Inadequate pathology | 11 | 2 |
| Overall Study | PET / CT not done | 3 | 5 |
| Overall Study | PET / CT poor quality | 2 | 1 |
Baseline characteristics
| Characteristic | Cervical Cancer Patients | Endometrial Cancer Patients | Total |
|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 11.6 | 64.8 years STANDARD_DEVIATION 9.9 | 58 years STANDARD_DEVIATION 13.2 |
| Sex: Female, Male Female | 153 Participants | 207 Participants | 360 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 108 / 169 | 132 / 215 |
| serious Total, serious adverse events | 17 / 169 | 19 / 215 |
Outcome results
Primary
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported sensitivity is reader average sensitivity by seven experienced PET-CT readers.
Time frame: Before surgery (FDG-PET-CT) and after surgery (pathology)
Population: Abdominal positive and negative patients. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cervical Cancer Patients | The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen | 50 percentage of participants |
| Endometrial Cancer Patients | The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen | 65 percentage of participants |
Primary
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in abdomen. The reported specificity is reader average specificity by seven experienced PET-CT readers.
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Population: Patients with abdominal positive and negative lymph nodes. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cervical Cancer Patients | The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen | 85 percentage of participants |
| Endometrial Cancer Patients | The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen | 88 percentage of participants |
Secondary
Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients
Number of cervical cancer patients with reasons of delay in the initiation of chemo-radiation therapy
Time frame: Within 4 weeks from PET/CT
Population: All Loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy and the reason they experienced a delay in the initiation of chemo-radiation
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervical Cancer Patients | Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients | Surgery related adverse events | 3 Participants |
| Cervical Cancer Patients | Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients | Patient preference/scheduling difficulty | 21 Participants |
| Cervical Cancer Patients | Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients | Other | 6 Participants |
| Cervical Cancer Patients | Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients | Not reported | 3 Participants |
| Cervical Cancer Patients | Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients | No Delay | 94 Participants |
Secondary
Cause of Interruption in Radiation Therapy in Cervical Cancer Patients
Number of cervical cancer patients with reasons of interruption in radiation therapy
Time frame: Within 6 weeks after surgery
Population: Loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy who experienced an interruption in radiation therapy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervical Cancer Patients | Cause of Interruption in Radiation Therapy in Cervical Cancer Patients | Chemoradiation related adverse events | 1 Participants |
| Cervical Cancer Patients | Cause of Interruption in Radiation Therapy in Cervical Cancer Patients | Patient preference/scheduling difficulty | 1 Participants |
| Cervical Cancer Patients | Cause of Interruption in Radiation Therapy in Cervical Cancer Patients | Other | 9 Participants |
| Cervical Cancer Patients | Cause of Interruption in Radiation Therapy in Cervical Cancer Patients | Not reported | 14 Participants |
| Cervical Cancer Patients | Cause of Interruption in Radiation Therapy in Cervical Cancer Patients | No interruption | 102 Participants |
Secondary
Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy
Number of participants with cervical cancer and a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0.
Time frame: During surgery and up to 30 days after surgery.
Population: All loco-regionally advanced cervical cancer patients who had extra-peritoneal or laparoscopic abdominal and pelvic lymphadenectomy
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervical Cancer Patients | Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy | Leukopenia | 1 Participants |
| Cervical Cancer Patients | Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy | Thrombocytopenia | 1 Participants |
| Cervical Cancer Patients | Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy | Anemia | 7 Participants |
| Cervical Cancer Patients | Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy | Other Hematologic | 1 Participants |
| Cervical Cancer Patients | Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy | Dermatologic | 1 Participants |
| Cervical Cancer Patients | Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy | Gastrointestinal | 4 Participants |
| Cervical Cancer Patients | Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy | Infection | 9 Participants |
| Cervical Cancer Patients | Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy | Lymphatics | 5 Participants |
| Cervical Cancer Patients | Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy | Metabolic | 3 Participants |
| Cervical Cancer Patients | Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy | Musculoskeletal | 1 Participants |
| Cervical Cancer Patients | Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy | Pain | 2 Participants |
| Cervical Cancer Patients | Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy | Vascular | 3 Participants |
Secondary
Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Population: Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervical Cancer Patients | Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes | 9 percentage of participants |
| Endometrial Cancer Patients | Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes | 10 percentage of participants |
Secondary
Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Population: Particpants with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervical Cancer Patients | Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node | 10 percentage of participants |
| Endometrial Cancer Patients | Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node | 6 percentage of participants |
Secondary
Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative by CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Population: Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cervical Cancer Patients | Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone | 77 percentage of participants |
| Endometrial Cancer Patients | Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone | 54 percentage of participants |
Secondary
Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative CT alone among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Population: Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cervical Cancer Patients | Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone | 42 percentage of participants |
| Endometrial Cancer Patients | Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone | 50 percentage of participants |
Secondary
Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative either CT alone among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of sensitivity is reader-average sensitivity across all 7 experienced PET-CT readers.
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Population: Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cervical Cancer Patients | Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone | 79 percentage of participants |
| Endometrial Cancer Patients | Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone | 48 percentage of participants |
Secondary
Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative byCT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Population: Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 23 randomly selected abdominal negative patients
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cervical Cancer Patients | Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone | 62 percentage of participants |
| Endometrial Cancer Patients | Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone | 89 percentage of participants |
Secondary
Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Population: Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cervical Cancer Patients | Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone | 89 percentage of participants |
| Endometrial Cancer Patients | Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone | 93 percentage of participants |
Secondary
Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative CT alone among the patients who do not have lymph node metastases identified by post-surgery pathology in pelvis. The reported estimate of specificity is reader-average specificity across all 7 experienced PET-CT readers.
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Population: Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cervical Cancer Patients | Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone | 63 percentage of participants |
| Endometrial Cancer Patients | Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone | 85 percentage of participants |
Secondary
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported sensitivity is reader-average sensitivity.
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Population: Patients with abdominal positive and negative lymph nodes. Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cervical Cancer Patients | The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis | 81 Percentage of participants |
| Endometrial Cancer Patients | The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis | 63 Percentage of participants |
Secondary
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis
The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in pelvis. The reported sensitivity is reader-averaged sensitivity.
Time frame: Before surgery (DCT) and after surgery (pathology)
Population: Patients with abdominal positive and negative lymph nodes. Cervical cancer cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cervical Cancer Patients | The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis | 83 percentage of participants |
| Endometrial Cancer Patients | The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis | 65 percentage of participants |
Secondary
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis
The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in combination of abdomen and pelvis. The reported specificity is reader-averaged specificity.
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Population: Cervical cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cervical Cancer Patients | The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis | 69 percentage of participants |
| Endometrial Cancer Patients | The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis | 83 percentage of participants |
Secondary
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis
The specificity is defined as the percentage of patients who test without lymph node metastases in pelvis by pre-operative PET/CT among the patients who do not have lymph node metastases in pelvis identified by post-surgery pathology. The reported specificity is reader-averaged specificity.
Time frame: Before surgery (FDG-PET/CT) and after surgery (pathology)
Population: Cervix cohort, first 40 abdominal positive and 40 randomly selected abdominal negative patients. Endometrial cancer cohort, all 23 abdominal positive and 26 randomly selected abdominal negative patients
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cervical Cancer Patients | The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis | 63 percentage of participants |
| Endometrial Cancer Patients | The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis | 93 percentage of participants |