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Corticosteroid

FFNP PET/MRI for Endometrial Cancer

Phase 2

Recruiting

Led By Jorge Oldan, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Histologically confirmed CAH or Grade 1 EC

No prior surgical or hormonal treatment for CAH or Grade 1 EC

Must not have

Known hypersensitivity to gadolinium or FFNP or to any component of gadolinium or FFNP refractory to standard medications (antihistamines, steroids)

Impaired kidney function (serum creatinine level > 1.8 mg/dl or a glomerular filtration rate < 60 as approximated using serum creatinine levels) unless anuric and on dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up upon completion of all study image data collection for all participants [approximately 1 year]

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a hormonal device and a special scan to see if they can predict how well women with certain uterine conditions will respond to treatment. The device releases a hormone to stop abnormal cell growth, and the scan checks if it's working.

Who is the study for?

This trial is for women aged 18 or older with confirmed Complex Atypical Hyperplasia (CAH) or Grade 1 Endometrial Cancer (EC), who are planning to be treated with a Levonorgestrel-releasing Intrauterine Device (LR-IUD). Participants should not have had previous surgical or hormonal treatments for these conditions. Women with certain metal implants, allergies to gadolinium or FFNP, severe kidney issues, pregnancy, prior hormone treatment for breast cancer, or extreme claustrophobia cannot join.

What is being tested?

The study is testing the effectiveness of an imaging scan called FFNP PET/MRI in predicting how well CAH and EC respond to hormonal therapy via LR-IUD. It's a small-scale pilot study involving eight participants who will undergo one FFNP PET/MRI scan each and have their medical records reviewed over six months.

What are the potential side effects?

Potential side effects may include allergic reactions to the FFNP compound used during the PET/MRI scan or gadolinium contrast agent. Kidney function might also be affected by the gadolinium if pre-existing conditions are present.

Eligibility Criteria

Inclusion Criteria

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

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My condition is confirmed as CAH or Grade 1 endometrial cancer.

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I have not had surgery or hormone treatment for CAH or early-stage endometrial cancer.

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I am a woman aged 18 or older.

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I am planning to use an IUD for my uterine condition.

Exclusion Criteria

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

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I am allergic to gadolinium or FFNP, and medications like antihistamines or steroids don't help.

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My kidney function is impaired, with high creatinine or low filtration rate, unless I'm on dialysis.

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I have received hormone therapy for breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ upon completion of all study image data collection for all participants [approximately 1 year]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~upon completion of all study image data collection for all participants [approximately 1 year]

This trial's timeline: 3 weeks for screening, Varies for treatment, and upon completion of all study image data collection for all participants [approximately 1 year] for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients

Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients

Secondary study objectives

Correlate FFNP Maximum Standardized Uptake Value (SUVmax) at baseline and on repeat examination with estrogen and progesterone receptor expression in the CAH/EC tissues at baseline and after 6 months of treatment.

Correlate FFNP Mean Standardized Uptake Value (SUVmean) at baseline and on repeat examination with estrogen and progesterone receptor expression in the CAH/EC tissues at baseline and after 6 months of treatment.