PET Imaging with 18F-FDG for Cervical Cancer

Palo Alto (17 mi)

Overseen byJennifer Mueller, MD

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for women over 18 with stage IB1 cervical cancer or high-grade endometrial cancer, who are fit for surgery and have controlled blood pressure. They must not be pregnant, have a hemoglobin level of at least 10 g/dL, albumin of at least 3 g/dL, glucose under 200 mg/dL, creatinine under 1.6 mg/dL, and no severe health conditions that would interfere with an MRI.

Inclusion Criteria

I am a woman with early-stage cervical cancer eligible for surgery.

I have stage I high-grade endometrial cancer and plan to have surgery.

My uterine cancer is of a high grade type.

My endometrial cancer is early stage but aggressive, shown by MRI or high CA-125 levels.

I am 18 years old or older.

I can carry out all self-care but cannot work.

My high blood pressure is well-managed.

I am medically cleared and considered suitable for surgery.

Exclusion Criteria

I cannot have an MRI due to a medical condition or device, or because I can't lie flat.

I am not cleared for surgery due to my health condition.

My high blood pressure is not under control.

My kidney function is low with high creatinine levels.

Treatment Details

The study tests if injecting a radioactive substance called 18F-FDG into the cervix before surgery can better identify which pelvic lymph nodes contain cancer using PET/CT or PET/MRI imaging techniques.

1Treatment groups

Experimental Treatment

Group I: intracervical 18F-FDG injection during a dynamic PET/CTExperimental Treatment3 Interventions

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.