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Corticosteroid

18F-fluorofuranylnorprogesterone 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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial is testing if a PET/MRI scan can predict how well Levonorgestrel-releasing Intrauterine Device (LR-IUD) hormonal therapy works for Complex Atypical hyperplasia (CAH) and Endometrial Cancer (EC).

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 18F-fluorofuranylnorprogesterone PET / MRIExperimental Treatment1 Intervention

All enrolled subjects will receive the tracer and then have a PET/MRI scan.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

353 Previous Clinical Trials

90,404 Total Patients Enrolled

9 Trials studying Endometrial Cancer

322 Patients Enrolled for Endometrial Cancer

Radiological Society of North AmericaOTHER

25 Previous Clinical Trials

1,811 Total Patients Enrolled

Jorge Oldan, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

3 Previous Clinical Trials

50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any risks associated with 18F-fluorofuranylnorprogesterone PET / MRI scans?

"We have rated the safety of 18F-fluorofuranylnorprogesterone PET / MRI as a 2. This is due to it being in Phase 2 trials, where there is evidence for safety but not efficacy."

Answered by AI

Are patients presently being recruited for this trial?

"The study, which is currently seeking participants, was originally posted on September 8th 2022 and was last updated on October 18th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

18-fluorofuranylnorprogesterone (FFNP) PET/MRI as a Potential Biomarker of Response to Progesterone Therapy

2024. "18-fluorofuranylnorprogesterone (FFNP) PET/MRI as a Potential Biomarker of Response to Progesterone Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05483023.

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