Imaging of Endometriosis With Total-body PET-CT (PET-Endo)

Sponsor
University of Edinburgh
Study ID
NCT07523997
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • 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. Attenuation-correction CT will be performed before acquisition of PET data
  • 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

Study Details

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.

Key Dates

First listed
Apr 13, 2026
Start date
Apr 8, 2026
Status verified
May 2026
Primary completion
Apr 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Suspected endometriosis
    Women/those assigned female at birth (aged ≥18 years) with chronic pelvic pain and a clinical/radiological diagnosis of likely endometriosis and due to undergo confirmatory laparoscopy in the subsequent four months.

Primary Outcome Measure

In vivo uptake of 18F-GP1 and 68Ga-FAPI in endometriosis [ Time Frame: within 3 months post surgery ]

Central Contacts

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