At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- PET/CT (diagnostic test), PET/MRI (diagnostic test), Buscopan 20 MG/ML Injectable Solution (drug)
- How long the study runs
- Study runs about 20 months (dates as stated)
- About the drug or intervention
- PET/CT — diagnostic test: Hybrid positron emission tomography and computed tomography will be performed after intravenous administration of the 68Ga-FAPI or the 18F-GP1 radiotracer and images centred on the pelvis. · PET/MRI — diagnostic test: Hybrid PET/MRI will be performed on a 3T scanner with T1 mapping immediately after the PET/CT with images acquired centred on the pelvis after injection of buscopan · Buscopan 20 MG/ML Injectable Solution — drug: IV injection prior to PET/MRI
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years to 60 Years
- Who
- Female
- Number of participants
- 30
- Started
- 2026-04-08
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for endometriosis
- • Clinical study - 30 participants
- • Endometriosis is a disease that affects 1 in 10 women and is associated with debilitating pain and infertility
Who can take part?
- • Ages 18 Years to 60 Years
- • Diagnosed with endometriosis
- • Female only
Where?
- • Edinburgh - Centre for Reproductive Health, Institute for Regeneration and Repair, University of Edinburgh
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Endometriosis is a disease that affects 1 in 10 women and is associated with debilitating pain and infertility. Endometriosis is where cells similar to those lining the womb (the 'endometrium') grow elsewhere in the body, forming 'lesions'. Most commonly the lesions grow on the lining of the pelvic cavity, called 'peritoneal' endometriosis. Lesions can also grow on the ovary, this is called 'ovarian' endometriosis, or form nodules, called 'deep' endometriosis. At present the only way to confidently identify endometriosis is through surgery, this exposes patient to the risks of surgery and contributes to the diagnostic delay associated with endometriosis. PET/CT is a specialist scan that is commonly used to identify cancers which cannot be seen on other types of scans. PET/CT uses a 'tracer', a substance given into a vein which then temporarily accumulates in areas of disease. This project will determine if a new specialist scan, total body PET/CT, and novel tracers that were developed for other conditions can be used to identify some of the key pathways in endometriosis: bleeding and scarring. Being able to identify these processes in endometriosis lesions and being able to track how they change over time would improve our understanding of endometriosis. The investigators also want to know if these pathways are different between superficial, deep and ovarian endometriosis, and what the impact is of the hormones related to the menstrual cycle. In this study up to 30 people who have suspected endometriosis and are already due to undergo diagnostic surgery will be asked to undergo two total-body PET/CT scans in Edinburgh, one at one visit and one another visit. Participants will also have a PET/MRI scan at visit. Participants will have a different tracer at each visit. The investigators will then compare the scan findings with their subsequent surgical findings.
More detail
This will be an observational cohort study using a prospectively recruited cohorts for both cross-sectional and longitudinal comparison across the spectrum of endometriosis subtypes. Up to 30 participants with a clinical/radiological diagnosis of likely endometriosis and due to undergo confirmatory laparoscopy in the subsequent four months will be recruited. Data collected at baseline includes demographics, clinical history including previous imaging. Participants will complete the WERF EPHect questionnaire Participants will attend two visits for imaging. They will undergo advanced imaging by total-body positron emission tomography and computed tomography (PET/CT), followed by PET/MRI for anatomical reconciliation of lesions and additional information about tracer dynamics. At one visit 68Ga-FAPI will be administered, and at the other 18F-GP1. IV buscopan will be given prior to the PET/MRI. Following completion of imaging studies, participants will be invited to complete an online acceptability questionnaire, and complete and optional qualitative interview about their experience. Subsequent surgical findings and associated histopathology will be correlated with tracer uptake
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 60 Years
- Who can join: Female only
What the study is looking for
- ✓Chronic pelvic pain
- ✓Clinical/radiological diagnosis of likely endometriosis and due to undergo confirmatory laparoscopy in the...
Who cannot take part
- ✗Inability or unwilling to give agreement to take part
- ✗Actively trying to conceive, pregnant or breastfeeding
- ✗Post menopausal (no periods for \>12 months and not taking hormonal treatments to prevent periods or bilateral...
- ✗Previous hysterectomy
- ✗Confirmed or suspected pelvic cancer
See the full criteria
Where Is This Study? (1 UK site)
Centre for Reproductive Health, Institute for Regeneration and Repair, University of Edinburgh
Edinburgh EH16 4UU, United Kingdom
How to Get in Touch
Lucy HR Whitaker, MD
Sponsor contactCONTACT