Cervical Cancer, Endometrial Cancer
Conditions
Keywords
18F-FDG Injection, Positron Lymphography, Lymphatic Mapping, sentinel lymph nodes, PET/CT, 14-222
Brief 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.
Interventions
Sponsors
Memorial Sloan Kettering Cancer Center
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
* 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 * Clear cell endometrial carcinoma * Grade 3 endometrioid carcinoma * Endometrial carcinosarcoma * Clinical stage I grade 1-2 endometrial cancer also eligible with deep myoinvasion ≥ 50% shown on preop MRI and/or elevated preop CA-125 \> 35 U/ml. * Age ≥18 years * Hemoglobin ≥10 g/dL * Plasma albumin ≥3 g/dL * GOG performance status ≤2 * Plasma glucose ≤200 mg/dL * Plasma creatinine ≤1.6 * Well-controlled hypertension * Medical clearance for surgery and considered an appropriate surgical candidate * 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 * Plasma albumin \<3 g/dL * GOG performance status \>2 * Plasma glucose \>200 mg/dL * Renal insufficiency with plasma creatinine \>1.6 * Uncontrolled hypertension * Patient does not meet medical clearance for surgery and is not considered an appropriate surgical candidate * Pregnancy For Stage 2: * Patient who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers of non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc. * Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diagnostic accuracy of Positron Lymphography | 2 years | Accuracy of Positron Lymphography will be defined in terms of sensitivity and will consist of pathology review of labelled, excised specimens compared with lymph node imaging data acquired preoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| to evaluate several standard uptake value (SUV) (18F-FDG avidity) | 2 years | will assess the ability of SUV to predict malignant disease. The continuous variable of SUV assigned to a given lymph node during Positron Lymphography will be compared with the pathologic assessment (benign vs malignant) of each labelled lymph node. The SUV assigned to a given lymph node is done using the the imaging software and not up to the discretion of the radiologist. |
Countries
United States
Outcome results
None listed