PET/MRI for Evaluation of Endometriosis

Summary

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.

Conditions

• Endometriosis
• Endometrioma

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.

Sponsors & Collaborators

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Onofrio Catalano · Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-06

Primary Completion

2028-01-03

Completion

2029-05-03

FDA Drug

Yes

Countries

• United States

Study Locations