PET/MRI for Evaluation of Endometriosis
Enrolling by invitation
Conditions studied: Endometriosis, Endometrioma
In brief
This study aims to determine if PET/MRI can detect endometriosis and potentially improve upon currently available non-invasive diagnostic capabilities. Specifically, the authors will investigate the ability of PET/MRI to detect and quantify endometriosis, as well as differentiate among subcategories such as inflammatory peritoneal lesions, fibrotic deep infiltrating endometriosis lesions (DIE), and ovarian endometriomas. The authors will compare \[68Ga\]CBP8 or \[18F\]-FAPI-74 PET/MRI imaging versus the current gold standard diagnostic methods, including laparoscopic surgery, clinical follow-up, and follow-up imaging.
Key facts
- Study ID
- NCT06377553
- Run by
- Massachusetts General Hospital
- People needed
- 60
- Starts
- 2025-01-06
- Expected to finish
- 2029-05-03
- Last updated by the study team
- 2026-03-12
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients with clinical diagnosis of endometriosis, in any stage, candidate for diagnostic overtherapeutic laparoscopic surgery.
You may not qualify if…
- Subjects less than 18 years of age or greater than 70 years of age.
- Any contraindication to MRI, including electrical implants, such as cardiac pacemakers or perfusion pumps. MRI non-compatible ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, prosthetic heart valves that are not compatible with the gradient maps of our scanners, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, steel implants, and/or ferromagnetic objects such as jewelry, or metal clips in clothing that cannot be removed.
- History of claustrophobic reactions.
- Individuals who do not speak or understand English since providing a translated version of the entire consent form is not practicable
- Any contraindication to PET including active breastfeeding (a negative STAT quantitative serum hCG pregnancy test is required on the day of the scan before the subject can participate)
- History of research-related radiation exposure exceeding current Radiology Department guidelines (i.e., 50 mSv in the prior 12 months).
- QTc>460msec obtained within 30 days from the PET/MR
- eGFR <60mL/min/1.73m2 obtained within 30 days from the PET/MR
- AST >40U/L and/or ALT >55 U/L obtained within 30 days from the PET/MR
- A greater risk than normal for potential cardiac arrest such as history of non compensated congestive heart failure, poorly controlled arrythmias, symptomatic non compensated cardiopathies.
- History of major head trauma (i.e., multiple concussions, traumatic brain injury).
- History of bleeding disorders.
- Inability to lie comfortably on a bed inside the PET/MRI bore as assessed by physical examination and medical history (e.g., back pain, severe arthritis).
- Subjects under the direct supervision of the principal investigator.
- Body weight of > 300 lbs. (weight limit of the MRI table) or BMI >33.0 per the standard operating procedure of PET/MRI safety at the Martinos Center.
- Subjects from any other at-risk populations (e.g., children and minors cognitively impaired persons, prisoners).
Where it is running
- Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School — Charlestown, Massachusetts, United States
Full record on ClinicalTrials.gov
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