Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02285192

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Endometrial Cancer	Radiation: 18F-Fluorodeoxyglucose (18F-FDG) Device: PET/CT imaging Device: PET/MRI imaging	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer

Actual Study Start Date :

Nov 1, 2014

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intracervical 18F-FDG injection during a dynamic PET/CT The first 20 eligible patients will be consented to undergo intracervical 18F-FDG injection during a dynamic PET/CT scan. Study enrollment will occur in the clinic during the visit in which they are consented for surgery. Recruited patients will undergo 18F-FDG-guided PET imaging on the day of their scheduled staging surgery. The experimental PET/CT is anticipated to take 2 hours. The second stage of accrual will replace PET/CT with PET/MRI imaging. In every other aspect, patients will receive standard peri- and postoperative care.	Radiation: 18F-Fluorodeoxyglucose (18F-FDG) Device: PET/CT imaging Device: PET/MRI imaging

Arm

Intervention/Treatment

Experimental: intracervical 18F-FDG injection during a dynamic PET/CT

The first 20 eligible patients will be consented to undergo intracervical 18F-FDG injection during a dynamic PET/CT scan. Study enrollment will occur in the clinic during the visit in which they are consented for surgery. Recruited patients will undergo 18F-FDG-guided PET imaging on the day of their scheduled staging surgery. The experimental PET/CT is anticipated to take 2 hours. The second stage of accrual will replace PET/CT with PET/MRI imaging. In every other aspect, patients will receive standard peri- and postoperative care.

Radiation: 18F-Fluorodeoxyglucose (18F-FDG)

Device: PET/CT imaging

Device: PET/MRI imaging

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Basking Ridge (Consent only)	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth (Consent only)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Consent only)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Commack (Consent only)	Commack	New York	United States
5	Memorial Sloan Kettering Westchester (Consent only)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (Consent only)	Uniondale	New York	United States	11553