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

NCT02285192 | Active Not Recruiting Phase 1

• 1 other identifier: 14-222
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 7

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.

Conditions

Cervical Cancer; Endometrial Cancer

Keywords

18F-FDG Injection; Positron Lymphography; Lymphatic Mapping; sentinel lymph nodes; PET/CT; 14-222

Outcome Measures

Primary Outcomes (1)

• diagnostic accuracy of Positron Lymphography

  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.

  2 years

Secondary Outcomes (1)

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

  2 years

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

18F-Fluorodeoxyglucose (18F-FDG) RADIATION

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

PET/CT imaging DEVICE

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

PET/MRI imaging DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Consent only)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Consent only)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, United States

Location

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Consent only)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Jennifer Mueller, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 6, 2014
• Study Start: November 1, 2014
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

US (7)