Imaging of Endometriosis With Total-body PET-CT (PET-Endo)
ConditionEndometriosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-60
SponsorUniversity of Edinburgh
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chronic pelvic pain
Clinical/radiological diagnosis of likely endometriosis and due to undergo confirmatory laparoscopy in the subsequent four months
Disqualifiers
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
Trial population
30 patients in NHS Lothian with clinically diagnosed endometriosis due to undergo confirmatory laparoscopy in the subsequent four months will be recruited. All subjects recruited for the study will be able to withdraw from the study at any time. The patients will be referred to the study by their treating physicians to investigate clinically diagnosed endometriosis. We will not recruit or enroll healthy volunteers in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
PET/CT
Diagnostic testHybrid 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 testHybrid 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
DrugIV injection prior to PET/MRI
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Suspected endometriosis3 interventions
Trial outcomes
Primary outcomes
1
In vivo uptake of 18F-GP1 and 68Ga-FAPI in endometriosis
Tracer uptake will be quantified by determining standardized uptake values (SUVs) and tissue to background ratio (TBR) in areas of increased uptake within the abdomen. This will correlated with surgical findings, specifically presence and location of endometriosis lesions.
Time frame
within 3 months post surgerySecondary outcomes
1
Non-invasive in vivo imaging-based characterisation of thrombosis and fibrosis characterisation in superficial, ovarian and deep endometriosis lesions
Tracer uptake will be quantified by determining standardized uptake values (SUVs) and tissue to background ratio (TBR) in areas of increased uptake within the abdomen. The relative values for the two separate tracers GP1 (activated platelets) and FAPI (fibrosis) will be correlated with the macroscopic appearance of lesions of differing subtypes at surgery.
Time frame
within 3 months post surgery2
Acceptability of PET imaging for characterisation of endometriosis
Bespoke acceptability questionnaire will be administered following surgery. Acceptability of the overall study and specific aspects will be rated on a 5 point Likert scale, with free text options for further detail. Data will summarised despitative, with thematic analysis of free text where able. Additional acceptability data will be derived from qualitative interviews of a purposive sample of participants and analysed thematically.
Time frame
within 3 months post surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Edinburgh
Lead sponsor
Life Molecular Imaging Ltd
Collaborator
Source ClinicalTrials.gov