18F-fluorofuranylnorprogesterone PET/MRI for Endometriosis

Overseen By Yueh Lee, MD, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Chronic progestins, GnRH analogues

Disqualifiers: Male, Cancer history, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method, 18F-fluorofuranylnorprogesterone PET/MRI (FFNP PET/MRI), to determine its accuracy in diagnosing endometriosis. This condition occurs when tissue similar to the uterine lining grows outside the uterus, often causing pain and other symptoms. The trial aims to compare the effectiveness of this imaging technique with existing methods. Women experiencing symptoms of endometriosis and planning laparoscopic surgery may qualify. Participants should avoid certain hormone treatments for a few cycles before joining. As a Phase 2 trial, this research measures the imaging method's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in diagnosing endometriosis.

Will I have to stop taking my current medications?

The trial requires that participants stop taking hormone treatments for at least two cycles before joining. If you are on chronic progestin-containing medications or GnRH analogues, you must discontinue them for 10-16 days or two cycles, respectively.

What prior data suggests that this method is safe for diagnosing endometriosis?

Research shows that a new type of scan called FFNP PET/MRI is being tested to help diagnose endometriosis. This scan uses a special substance, known as a tracer, to enhance image clarity. Interest surrounds the safety of this tracer for humans.

Currently, specific information about the safety of FFNP PET/MRI in people is limited. However, PET/MRI scans are commonly used in medicine and are generally safe, with few serious side effects.

This study is in its early stages, so researchers are still determining the safety and effectiveness of FFNP PET/MRI for diagnosing endometriosis. Early studies usually involve fewer participants to closely monitor any side effects. So far, this study has shown no strong evidence of major safety issues with FFNP PET/MRI. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 18F-fluorofuranylnorprogesterone PET/MRI for endometriosis because it offers a novel way to detect and visualize endometriosis lesions. Unlike current methods, which often rely on invasive surgery or less specific imaging techniques, this approach uses a specialized tracer that specifically highlights areas affected by endometriosis during the scan. This could lead to more accurate diagnoses and help doctors tailor treatments more effectively, potentially improving outcomes for patients suffering from this condition.

What evidence suggests that FFNP PET/MRI is effective for diagnosing endometriosis?

Research shows that a new imaging method called FFNP PET/MRI holds promise for diagnosing endometriosis. Studies have found that a shorter version of the MRI used in this method matches the full version's accuracy, with rates between 83% and 86%. This trial will evaluate FFNP PET/MRI as a reliable tool for detecting endometriosis. The technique aims to enhance the accuracy of diagnosing endometriosis, which current methods often struggle to achieve. These early results suggest that this imaging method could offer improved precision in diagnosis. ^{1 2 3 4 6}

Who Is on the Research Team?

Jorge Oldan, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for women aged 18-55 who may have endometriosis, are scheduled for laparoscopy, and haven't taken hormone treatments recently. Participants must be able to consent and not be institutionalized or pregnant. They should not have a history of certain cancers or allergies to contrast used in MRI.

Inclusion Criteria

My doctor suspects I have endometriosis based on my symptoms.

Able to provide informed consent

I am scheduled for a laparoscopy and haven't taken hormone treatment for at least two cycles.

Exclusion Criteria

I am male.

Institutionalized subject (prisoner or nursing home patient)

I haven't taken hormone therapies like progestin or GnRH analogues in the last 10-16 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive the 18F-fluorofuranylnorprogesterone tracer and undergo a PET/MRI scan to assess the presence of endometriosis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for diagnostic accuracy and correlation of imaging results with clinical outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• 18F-fluorofuranylnorprogesterone PET / MRI

Trial Overview The study tests the effectiveness of a PET/MRI scan using a tracer called FFNP to diagnose endometriosis in women with symptoms suggestive of the condition. It's a single-group study aiming to determine how well this imaging technique can identify endometriosis.

How Is the Trial Designed?

Group I: 18F-fluorofuranylnorprogesterone PET / MRI Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

An abbreviated MRI protocol for diagnosing pelvic endometriosis demonstrated comparable accuracy (0.83-0.86) to a full MRI protocol (0.83-0.87), indicating it can be an effective alternative.

Both intra-reader and inter-reader agreements were substantial to almost perfect, suggesting that the abbreviated protocol is reliable and reproducible regardless of the radiologists' experience levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of imaging interpretation, intra- and inter-reader agreement for diagnosis of pelvic endometriosis: comparison between an abbreviated and full MRI protocol. da Silva, LLC., Torres, US., Torres, LR., et al.[2023]

The study demonstrated that (18)F-FFNP PET is a safe and effective method for imaging progesterone receptors in breast cancer, with no adverse effects reported in 20 patients.

While the maximum uptake of (18)F-FFNP was similar in both PR-positive and PR-negative tumors, the tumor-to-normal breast activity ratio was significantly higher in PR-positive cancers, indicating better imaging potential for these tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of progesterone receptors in breast carcinoma by PET with 21-18F-fluoro-16α,17α-[(R)-(1'-α-furylmethylidene)dioxy]-19-norpregn-4-ene-3,20-dione. Dehdashti, F., Laforest, R., Gao, F., et al.[2021]

MRI is highly effective in diagnosing endometriosis, particularly for detecting deep infiltrating implants, due to its superior soft tissue contrast and multiplanar imaging capabilities.

The review highlights that MRI can significantly enhance preoperative diagnosis of endometriosis compared to traditional methods like physical exams and laparoscopy, although it also notes some limitations in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance and perspective of magnetic resonance imaging in the evaluation of endometriosis. Bianek-Bodzak, A., Szurowska, E., Sawicki, S., et al.[2022]

In a study of 83 women with confirmed endometriosis, pelvic magnetic resonance (MR) imaging detected endometriosis in 61% of cases, significantly higher than the 22% detection rate from routine pelvic ultrasound (US).

MR imaging not only identified more cases of endometriosis but also revealed additional disease locations and complications in many patients, highlighting its superior efficacy in assessing the extent of the disease compared to US.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of routine pelvic US and MR imaging in patients with pathologically confirmed endometriosis. Bartlett, DJ., Burkett, BJ., Burnett, TL., et al.[2021]

MRI is a promising non-invasive alternative for diagnosing endometriosis, which is traditionally diagnosed through invasive and costly diagnostic laparoscopy.

The Society of Abdominal Radiology's Disease-Focused Panel provides technical recommendations to enhance the effectiveness of MRI in evaluating endometriosis, potentially improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for MRI technique in the evaluation of pelvic endometriosis: consensus statement from the Society of Abdominal Radiology endometriosis disease-focused panel. Tong, A., VanBuren, WM., Chamié, L., et al.[2021]

In a study involving rhesus macaques, uterine uptake of radiotracers targeting estrogen and progesterone receptors was found to be higher during the proliferative phase of the menstrual cycle compared to the secretory phase, indicating hormonal influence on receptor activity.

Macaques with endometriosis showed significantly higher uterine uptake of the estrogen receptor-targeting radiotracer (FES) compared to those without the condition, suggesting that endometriosis alters typical reproductive tract function and may help in identifying affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uterine uptake of estrogen and progestogen-based radiotracers in rhesus macaques with endometriosis. Wilson, RC., Link, JM., Lee, YZ., et al.[2023]

MRI is a reliable and non-invasive method for diagnosing endometriosis, showing high diagnostic value for detecting endometriotic cysts and implants using specific imaging sequences.

The review emphasizes that MRI should be considered a complementary tool to laparoscopy, particularly for visualizing changes in uterine anatomy associated with adenomyosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Magnetic resonance imaging (MRI) of the pelvis in diagnosing endometriosis]. Hauth, EA., Stattaus, J., Kimmig, R., et al.[2008]

Citations

1. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/542097

Evaluation of Endometriosis With 18F ... Purpose: The aim of this study is to assess the sensitivity and specificity of FFNP PET/MRI for diagnosis of endometriosis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05480995

NCT05480995 | Evaluation of Endometriosis With 18F- ... Purpose: The aim of this study is to assess the sensitivity and specificity of FFNP PET/MRI for diagnosis of endometriosis. Participants: A total of 24 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05480995?tab=table

Researcher View | Evaluation of Endometriosis With 18F- ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

4. withpower.com withpower.com/trial/phase-2-endometriosis-8-2022-e7090

18F-fluorofuranylnorprogesterone PET/MRI for Endometriosis An abbreviated MRI protocol for diagnosing pelvic endometriosis demonstrated comparable accuracy (0.83-0.86) to a full MRI protocol (0.83-0.87), indicating it ...

5. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct05480995

Evaluation of Endometriosis With 18F ... Purpose: The aim of this study is to assess the sensitivity and specificity of FFNP PET/MRI for diagnosis of endometriosis. Participants: A total of 24 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05483023

18-fluorofuranylnorprogesterone (FFNP) PET/MRI as a ... Purpose: The purpose of this study is to evaluate FFNP PET/MRI's utility for predicting response to Levonorgestrel-releasing Intrauterine Device (LR-IUD) ...