NCT05390021

PET/MRI in Endometrial Cancer

Diagnostic Performance of PET/MRI Versus Standard of Care Imaging (PET/CT and/or CT and/or PET) in Preoperative Women With Presumed Early-stage High Grade Endometrial Carcinoma

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is investigating if positron emission tomography (PET)/Magnetic resonance imaging (MRI) is more effective than the currently used imaging modalities (computed tomography \[CT\], or PET/CT) for high-risk endometrial cancer. The name of the intervention involved in this study is: Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI)

Detailed description

This research study involves undergoing a diagnostic imaging procedure called positron emission tomography/magnetic resonance imaging (PET/MRI). This type of scan uses a powerful magnet and a special drug that emits a small but detectable amount of radiation to show detailed images of tumors. This study, will examine the diagnostic effectiveness of positron emission tomography/magnetic resonance imaging (PET/MRI), which will be the intervention. The study will compare the results of this scan to either the computed tomography (CT) or PET/CT that participants would normally undergo as a standard of care for high-risk endometrial cancer. The research study procedures include a screening for eligibility and a single study visit. * Participants will undergo the PET/MRI in one study visit of approximately four hours. * It is expected that about thirty-three (33) people will take part in this research study. The U.S. Food and Drug Administration (FDA) has approved the PET/MRI scanner as a diagnostic modality option for indications that include for high-risk endometrial cancer.

Conditions

• Cytoreductive Surgery
• Grade 3 Endometrial Endometrioid Adenocarcinoma
• High Grade Serous Carcinoma
• Endometrial Undifferentiated Carcinoma
• Endometrial Mixed Cell Adenocarcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent	The research study procedures include a screening for eligibility and a single study visit. PET/MRI in one study visit of approximately four hours.

Timeline

• Start date: 2024-03-30
• Primary completion: 2025-02-01
• Completion: 2026-02-01
• First posted: 2022-05-25
• Last updated: 2024-04-02

Regulatory

• FDA-regulated device study