PET/MRI for Evaluation of Endometriosis

Launched by MASSACHUSETTS GENERAL HOSPITAL · Apr 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called PET/MRI to see if it can better detect and measure endometriosis, a condition where tissue similar to the lining of the uterus grows outside of it. The researchers want to find out if this new method can identify different types of endometriosis, such as lesions in the abdomen or cysts on the ovaries, and see how it compares to the current best methods, which often involve surgery.

To participate in this trial, you need to be a woman between the ages of 18 and 70 who has been diagnosed with endometriosis and is scheduled for a surgery to diagnose it. However, there are some restrictions; for instance, if you have certain medical implants, experience claustrophobia, or have specific health conditions, you may not be eligible. If you join the study, you will undergo PET/MRI imaging, which is a type of scan that combines two different imaging techniques to give a detailed view of your condition. This could help improve how doctors diagnose and treat endometriosis in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • - Patients with clinical diagnosis of endometriosis, in any stage, candidate for diagnostic overtherapeutic laparoscopic surgery.
• Exclusion Criteria:
• • 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).