PET/MRI for Evaluation of Endometriosis

Enrolling by invitationOBSERVATIONAL
Enrollment

60

Participants

Timeline

Start Date

January 6, 2025

Primary Completion Date

January 3, 2026

Study Completion Date

May 3, 2026

Conditions
EndometriosisEndometrioma
Interventions
DRUG

Radiotracer Injection

"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."

DIAGNOSTIC_TEST

Imaging

"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"

OTHER

Rectal Ultrasound Gel Injection

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.

Trial Locations (1)

02129

Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown

All Listed Sponsors
lead

Massachusetts General Hospital

OTHER