What this study is
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.
What's being tested
- Radiotracer Injection
Intervention · 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
Intervention · 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
Intervention · 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
- Official title
- PET/MRI Evaluation of Endometriosis Using Intercellular Matrix Radiopharmaceuticals
- Sponsor
- Massachusetts General Hospital
- Conditions
- Endometriosis · Endometrioma
- Enrolling
- 60 people
- Starts
- 2025-01-06
- Est. completion
- 2029-05-03
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 70 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Patients with clinical diagnosis of endometriosis, in any stage, candidate for diagnostic overtherapeutic laparoscopic surgery.
You can't join if
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openAthinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School
Charlestown, Massachusetts, United States
Study team
Sponsor
Massachusetts General Hospital
Study ID 2023P000955
Principal investigator
Onofrio Catalano
Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.