NCT06377553
PET/MRI for Evaluation of Endometriosis
Enrolling by Invitation
Not specifiedAges 18–70ObservationalMassachusetts General HospitalInvestigator-initiated
~60 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:Radiotracer InjectionImagingRectal Ultrasound Gel Injection
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnostic Accuracy of PET/MR in Preoperative Endometriosis Detection
Measured over 1-2 Months
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Study leadership
- Onofrio Catalano · PRINCIPAL_INVESTIGATOR · Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Exclusion
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).
What this trial measures
- Diagnostic Accuracy of PET/MR in Preoperative Endometriosis Detection1-2 Months
To determine the accuracy, sensitivity, and specificity of \[18F\]-FAPI-74 and/or \[68Ga\]CBP8 PET/MRI in detecting and classifying endometriosis, using the gold standard methods as the reference.
- Diagnostic Performance of PET/MRI vs. Conventional Imaging1-2 Months
To determine the accuracy, sensitivity, and specificity of \[18F\]-FAPI-74 or \[68Ga\]CBP8-PET/MR images versus stand-alone wholebody MRI and/or pelvic MRI and/or ultrasound and/or computed tomography in pre-operative patients with suspected endometriosis lesion.