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

Brief Title

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

Official Title

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

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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

diagnostic accuracy of Positron Lymphography

Secondary Outcome

 to evaluate several standard uptake value (SUV) (18F-FDG avidity)

Condition

Cervical Cancer

Intervention

18F-Fluorodeoxyglucose (18F-FDG)

Study Arms / Comparison Groups

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

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Radiation

Estimated Enrollment

Start Date

November 2014

Completion Date

November 2020

Primary Completion Date

November 2020

Eligibility 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

               -  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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jennifer Mueller, MD, 212-639-8229, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02285192

Organization ID

14-222

Responsible Party

Sponsor

Study Sponsor

Memorial Sloan Kettering Cancer Center

Study Sponsor

Jennifer Mueller, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center

Verification Date

January 2020