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PET Imaging with 18F-FDG for Cervical Cancer

Phase 1

Waitlist Available

Led By Jennifer Mueller, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women with stage IB1 cervical cancer (any histologic subtype) deemed eligible for surgery

Women with clinical stage I high-grade endometrial cancer planning to undergo surgical staging

Must not have

For Stage 2: Patients unwilling or unable to undergo MRI including patients with contraindications to MRI such as presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study

Patient does not meet medical clearance for surgery and is not considered an appropriate surgical candidate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a radioactive substance can help doctors better see which lymph nodes contain cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions to the radioactive tracer like rash or itching (rare), discomfort from injection site, and typical risks associated with undergoing PET/CT or PET/MRI scans such as exposure to radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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My uterine cancer is of a high grade type.

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

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I am 18 years old or older.

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

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My high blood pressure is well-managed.

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I am medically cleared and considered suitable for surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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My high blood pressure is not under control.

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My kidney function is low with high creatinine levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

diagnostic accuracy of Positron Lymphography

Secondary study objectives

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

Side effects data

From 2018 Phase 2 & 3 trial • 385 Patients • NCT02981368

hyperkalaemia

spinal cord compression

atrial fibrillation

pyelonephritis, acute

coronary artery disease

Lower gastrointestinal haemmorhage

dysgeusia

100%

80%

60%

40%

20%

Study treatment Arm

Recurrent or Metastatic Prostate Cancer (Cohort B)

High Risk Prostate Cancer (Cohort A)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PET/CT imaging

2021

Completed Phase 3

~430

0 / 12Eligibility criteria met