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Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer
Conditions
Cervical Cancer - Endometrial Cancer
Conditions: official terms
Endometrial Neoplasms - Uterine Cervical Neoplasms
Conditions: Keywords
18F-FDG Injection, Positron Lymphography, Lymphatic Mapping, sentinel lymph nodes, PET/CT, 14-222
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: 18F-Fluorodeoxyglucose (18F-FDG)
Type: Radiation
Name: PET/CT imaging
Type: Device
Overall Status
Recruiting
Summary
The purpose of this study is to see if a radioactive substance called 18F-Fluorodeoxyglucose (18F- FDG), injected into the cervix during a PET/CT scan done before surgery can show us more clearly which lymph nodes in the pelvis (the area near your uterus and cervix) contain cancer.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:
- The study population will include women with stage IB1 cervical cancer (any histologic subtype) deemed eligible for surgery, and women with a clinical stage I high-grade endometrial cancer planning to undergo surgical staging. High grade is defined by the following:
- Uterine serous carcinoma (all stage and grade)
- Clear cell endometrial carcinoma (all stage and grade)
- Grade 3 endometrial carcinoma (all histology)
- Endometrial carcinosarcoma (all stage and grade)
- Age ≥18 years
- Hemoglobin ≥10 g/dL
- Serum albumin ≥3 g/dL
- Elevated preoperative CA-125 > 35 U/ml or abnormal CA-125 level
- Deep myoinvasion ≥ 50% shown by preoperative MRI
- GOG performance status ≤2
- No active coronary artery disease (defined as unstable angina or positive cardiac stress test)
- No history of cerebrovascular disease
- Serum glucose ≤200 mg/dL
- Serum creatinine ≤1.6
- Well-controlled hypertension
- No history of restrictive or obstructive pulmonary disease
- No history of congestive heart failure
- No active infections
- Negative serum pregnancy test, if of child-bearing potential
- If, based on surgeon's assessment, the patient is recommended to undergo surgical staging for histologically confirmed endometrial cancer or if IB1 cervical cancer is deemed eligible for surgical treatment of disease
- Participation in other research protocols does not exclude a patient from participation in this study
Exclusion Criteria:
- Hemoglobin <10 g/dL
- Serum albumin <3 g/dL
- GOG performance status >2
- Active coronary artery disease (defined as unstable angina or positive cardiac stress test)
- History of cerebrovascular disease
- Serum glucose >200 mg/dL
- Renal insufficiency with serum creatinine >1.6
- Uncontrolled hypertension
- Restrictive or obstructive pulmonary disease
- Congestive heart failure
- Active infection
- Pregnancy
- The study population will include women with stage IB1 cervical cancer (any histologic subtype) deemed eligible for surgery, and women with a clinical stage I high-grade endometrial cancer planning to undergo surgical staging. High grade is defined by the following:
- Uterine serous carcinoma (all stage and grade)
- Clear cell endometrial carcinoma (all stage and grade)
- Grade 3 endometrial carcinoma (all histology)
- Endometrial carcinosarcoma (all stage and grade)
- Age ≥18 years
- Hemoglobin ≥10 g/dL
- Serum albumin ≥3 g/dL
- Elevated preoperative CA-125 > 35 U/ml or abnormal CA-125 level
- Deep myoinvasion ≥ 50% shown by preoperative MRI
- GOG performance status ≤2
- No active coronary artery disease (defined as unstable angina or positive cardiac stress test)
- No history of cerebrovascular disease
- Serum glucose ≤200 mg/dL
- Serum creatinine ≤1.6
- Well-controlled hypertension
- No history of restrictive or obstructive pulmonary disease
- No history of congestive heart failure
- No active infections
- Negative serum pregnancy test, if of child-bearing potential
- If, based on surgeon's assessment, the patient is recommended to undergo surgical staging for histologically confirmed endometrial cancer or if IB1 cervical cancer is deemed eligible for surgical treatment of disease
- Participation in other research protocols does not exclude a patient from participation in this study
Exclusion Criteria:
- Hemoglobin <10 g/dL
- Serum albumin <3 g/dL
- GOG performance status >2
- Active coronary artery disease (defined as unstable angina or positive cardiac stress test)
- History of cerebrovascular disease
- Serum glucose >200 mg/dL
- Renal insufficiency with serum creatinine >1.6
- Uncontrolled hypertension
- Restrictive or obstructive pulmonary disease
- Congestive heart failure
- Active infection
- Pregnancy
Location
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Nadeem Abu-Rustum, MD - 212-639-7051
Start Date
November 2014
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page