PET/MRI for Evaluation of Endometriosis

Part of paid clinical trials in Charlestown, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06377553
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Radiotracer Injection — DRUG
    An intravenous catheter will be placed in an arm or hand vein for injection of \[68Ga\]CBP8; 6-10 mCi of \[68Ga\]CBP8 or 5-9 mCi of FAPI will be injected into the Biograph mMR system. The injected dose and the time of injection will be recorded; The catheter will be flushed with 0.9% saline solution; The subjects will then be positioned on the scanner table; support devices under the back or legs will be used to enable the patient to maintain his/her position throughout the scan comfortably.
  • Imaging — DIAGNOSTIC_TEST
    MRI and PET scanner to be used: 3.0 T Laboratory (Bay 7) Siemens Biograph mMR. Magnetic resonance images of the pelvis and abdomen will be acquired using the Martinos Center's combined 3 Tesla PET/MRI scanner. The image quality on these 3 Tesla devices will be very high, equivalent to or better than any other standard clinical MRI system. PET images of the target body site will be acquired when necessary, the data acquisition will be started shortly before radiotracer injection; Coincidence event data will be acquired and stored in list mode or compressed (i.e., sinogram space) format. Subjects will be asked to lie still for the duration of the study. The entire imaging session will last up to 120 minutes
  • Rectal Ultrasound Gel Injection — OTHER
    About 50ml of ultrasound gel will be placed into the vagina using the blunt end of the ultrasound gel tube or a Foley catheter or a syringe with a blunt Christmas tree end. No ultrasound probe will be inserted into the vagina, no external ultrasound probe will be used. No ultrasound study will be performed. The ultrasound gel will only be used to distend the vagina and improve the quality of MRI images; this is standard of practice in MRI for endometriosis and for several other gynecological diseases.

Study Details

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 Dates

Start date
Jan 6, 2025
Status verified
Mar 2026
Primary completion
Jan 3, 2028
Completion
May 3, 2029

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Endometriosis
    Patient with clinical diagnosis of endometriosis, in any stage, candidate for diagnostic or therapeutic laparoscopic surgery.

Primary Outcome Measure

Diagnostic Accuracy of PET/MR in Preoperative Endometriosis Detection [ Time Frame: 1-2 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical SchoolCharlestownMassachusetts02129-

Find similar trials in Charlestown, MA

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School· Charlestown, MA

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