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NCT07523997

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

Sponsor: University of Edinburgh

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-04-01

Completion Date

2027-12-31

Last Updated

2026-04-13

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

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

Edinburgh, City of Edinburgh, United Kingdom