NCT07523997

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Endometriosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PET/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_TEST	PET/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
DRUG	Buscopan 20 MG/ML Injectable Solution	IV injection prior to PET/MRI

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-12-31
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: United Kingdom