NCT06377553Enrolling by invitation
PET/MRI for Evaluation of Endometriosis
PET/MRI Evaluation of Endometriosis Using Intercellular Matrix Radiopharmaceuticals
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 17 Apr 2024
- Start date
- 6 Jan 2025
- Primary completion date
- 3 Jan 2028
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Endometriosis
- NCT number
- NCT06377553
What you commit to
- Study type: Observational
- Planned participants: 60
- From 6 Jan 2025 to the primary completion date, 3 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of research-related radiation exposure exceeding current Radiology Department guidelines (i.e., 50 mSv in the prior 12 months).
Other illness
- 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.
Lab values
- 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
Age
- Subjects less than 18 years of age or greater than 70 years of age.
Other
- 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).
Who the study is looking for
- \- Patients with clinical diagnosis of endometriosis, in any stage, candidate for diagnostic overtherapeutic laparoscopic surgery.
Age in the registry: 18 years to 70 years · Sex: Female
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School Coordinator of this site? Confirm its status | Charlestown | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.