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

Trial Summary

What is the purpose of this trial?

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 participants will be recruited from individuals with clinically suspected endometriosis. Procedures (methods): This is a prospective, one arm, single center study of 24 subjects with clinically suspected endometriosis to demonstrate FFNP PET-MRI's clinical utility for diagnosis of 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 data supports the effectiveness of the treatment 18F-fluorofuranylnorprogesterone PET/MRI for endometriosis?

Research on rhesus macaques suggests that the radiotracer 18F-fluorofuranylnorprogesterone (FFNP) can target progesterone receptors, which may help in identifying endometriosis. Additionally, MRI is recognized for its ability to diagnose endometriosis effectively, especially in detecting deep infiltrating implants. ^{1 2 3 4 5}

How does the 18F-fluorofuranylnorprogesterone PET/MRI treatment for endometriosis differ from other treatments?

This treatment is unique because it uses a special imaging technique (PET/MRI) with a radiotracer that targets progesterone receptors, allowing for non-invasive detection and assessment of endometriosis, unlike traditional methods that often require surgery. ^{1 2 4 6 7}

Research Team

Jorge Oldan, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

References

1. United States 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The importance and perspective of magnetic resonance imaging in the evaluation of endometriosis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of routine pelvic US and MR imaging in patients with pathologically confirmed endometriosis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Uterine uptake of estrogen and progestogen-based radiotracers in rhesus macaques with endometriosis. [2023]

5. United States 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. [2021]

6. United States 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. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

[Magnetic resonance imaging (MRI) of the pelvis in diagnosing endometriosis]. [2008]