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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 1

Conditions: Endometrial Cancer; Cervical Cancer

Treatments: Radiation: 18F-Fluorodeoxyglucose (18F-FDG); Device: PET/CT imaging; Device: PET/MRI imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02285192

14-222

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

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

Experimental group

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.

Treatment:

Device: PET/MRI imaging

Device: PET/CT imaging

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