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PET/MRI for Evaluation of Endometriosis

Key facts

Where
Charlestown, United StatesSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Source: NCT06377553, who can take part

Where in United States

  • Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical SchoolCharlestown, United StatesNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Massachusetts General Hospital
Trial code
NCT06377553
Record updated
12 March 2026
Original description
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.Read full original descriptionShow less

PET/MRI Evaluation of Endometriosis Using Intercellular Matrix Radiopharmaceuticals

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.

Inclusion: Patients with clinical diagnosis of endometriosis, in any stage, candidate for diagnostic overtherapeutic laparoscopic surgery.

Exclusion: History of research-related radiation exposure exceeding current Radiology Department guidelines (i.e., 50 mSv in the prior 12 months); 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; 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; 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); 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; Subjects less than 18 years of age or greater than 70 years of age; Individuals who do not speak or understand English since providing a translated version of the entire consent form is not practicable; 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).

ClinicalTrials.gov NCT06377553