18F-fluorofuranylnorprogesterone PET/MRI for Endometriosis
Recruiting in Palo Alto (17 mi)
Overseen ByJorge Oldan, MD
Age: 18 - 65
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of North Carolina, Chapel Hill
No Placebo Group
Prior Safety Data
Approved in 2 jurisdictions
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.
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.
34567How 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.
12367Will 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.
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.Participant Groups
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.
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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of North Carolina at Chapel HillChapel Hill, NC
Loading ...
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
[Magnetic resonance imaging (MRI) of the pelvis in diagnosing endometriosis]. [2008]Widely accepted as an established method in the diagnostic imaging of diseases of the female pelvis, magnetic resonance imaging (MRI) holds promising potential for the diagnosis of endometriosis. This review describes the general prerequisites for performing MRI scans of the pelvis and presents, based on recent studies, an imaging protocol suited to the diagnosis of endometriosis. Typical manifestations and sites of endometriosis are discussed and illustrated with sample images. For endometriotic cysts and implants, axial T (1)-weighted, fat-saturated turbo spin echo sequences (TSE) have the highest diagnostic value. In diagnosing adenomyosis, sagittal T (2)-weighted TSE sequences visualise changes in the uterine zonal anatomy. In essence, MRI is capable of detecting many manifestations of endometriosis in a non-invasive, yet reliable manner, and its value in relation to laparoscopy must be considered as complementary.
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]This first-in-human study was designed to evaluate the safety and dosimetry of the progesterone analog 21-(18)F-fluoro-16α,17α-[(R)-(1'-α-furylmethylidene)dioxy]-19-norpregn-4-ene-3,20-dione ((18)F-FFNP), as well the feasibility of imaging tumor progesterone receptors (PRs) by PET in breast cancer.
The importance and perspective of magnetic resonance imaging in the evaluation of endometriosis. [2022]MR imaging is becoming increasingly important in the assessment of patients with endometriosis. Its multiplanar capabilities and superior soft tissue contrast are particularly useful in the detection of deep infiltrating endometriotic implants. Endometriosis, defined as the presence of endometrial glands and stroma outside the endometrium, is among the most common gynaecological disorders affecting women in their reproductive age. The diagnosis and evaluation of the extension of endometriosis are difficult only with physical examination and laparoscopy. According to the authors' personal experience, a special MRI technique and some imaging guidelines regarding different anatomical localizations of endometriosis are discussed. This review is a brief presentation of current evidence on the diagnostic accuracy of MRI in the evaluation of endometriosis concerning other diagnostic methods, the limitations of MRI and its essential usefulness for preoperative diagnosis of deep pelvic endometriosis, and future perspectives in monitoring this disease.
Comparison of routine pelvic US and MR imaging in patients with pathologically confirmed endometriosis. [2021]To estimate the benefit of pelvic magnetic resonance (MR) imaging after routine pelvic ultrasound (US) in patients with pathologically or surgically proven endometriosis.
Recommendations for MRI technique in the evaluation of pelvic endometriosis: consensus statement from the Society of Abdominal Radiology endometriosis disease-focused panel. [2021]Endometriosis is a common entity causing chronic pain and infertility in women. The gold standard method for diagnosis is diagnostic laparoscopy, which is invasive and costly. MRI has shown promise in its ability to diagnose endometriosis and its efficacy for preoperative planning. The Society of Abdominal Radiology established a Disease-Focused Panel (DFP) to improve patient care for patients with endometriosis. In this article, the DFP performs a literature review and uses its own experience to provide technical recommendations on optimizing MRI Pelvis for the evaluation of endometriosis.
Performance of imaging interpretation, intra- and inter-reader agreement for diagnosis of pelvic endometriosis: comparison between an abbreviated and full MRI protocol. [2023]To compare the performance of imaging interpretation, intra- and inter-reader agreement between an abbreviated (aMRI) and full (fMRI) MRI protocol for diagnosis of pelvic endometriosis.
Uterine uptake of estrogen and progestogen-based radiotracers in rhesus macaques with endometriosis. [2023]Label="Purpose" NlmCategory="UNASSIGNED">Few investigations have examined the uptake of radiotracers that target the prominent sex-steroid receptors in the uterus across the menstrual cycle and with disease state. We aimed to determine if uptake of the radiotracers that target estrogen and progesterone receptors (ER and PR) differ with the presence of endometriosis and/or across the menstrual cycle. We performed PET and computed tomography (CT) imaging procedures on rhesus macaques (Macaca mulatta) using 16α-[18F]fluoroestradiol (FES) and 21-[18F]fluoro-furanyl-nor-progesterone (FFNP) in individuals with and without endometriosis in the proliferative and secretory phases of the menstrual cycle.