RecruitingNCT07523997

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

Novel Non-invasive Imaging of Endometriosis Using Total-body PET-CT Programme (PET-Endo)


Sponsor

University of Edinburgh

Enrollment

30 participants

Start Date

Apr 8, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Inclusion Criteria2

  • Chronic pelvic pain
  • Clinical/radiological diagnosis of likely endometriosis and due to undergo confirmatory laparoscopy in the subsequent four months

Exclusion Criteria10

  • Inability or unwilling to give informed consent
  • Actively trying to conceive, pregnant or breastfeeding
  • Post menopausal (no periods for >12 months and not taking hormonal treatments to prevent periods or bilateral oophorectomy performed)
  • Previous hysterectomy
  • Confirmed or suspected pelvic malignancy
  • Contraindication to MRI (ferromagnetic material in the body, metallic device implantation or claustrophobia)
  • Contraindication to buscopan (e.g. glaucoma, unstable cardiac disease, arrythmias, myasthenia, previous hypersensitivity to buscopan)
  • Taking part in a CTIMP or interventional non-CTIMP study
  • Previous severe pelvic inflammatory disease
  • Previous peritonitis

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Interventions

DIAGNOSTIC_TESTPET/CT

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

DIAGNOSTIC_TESTPET/MRI

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

DRUGBuscopan 20 MG/ML Injectable Solution

IV injection prior to PET/MRI


Locations(1)

Centre for Reproductive Health, Institute for Regeneration and Repair, University of Edinburgh

Edinburgh, City Of Edinburgh, United Kingdom

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NCT07523997


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