PET/MRI in Endometrial Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05390021|
Recruitment Status : Not yet recruiting
First Posted : May 25, 2022
Last Update Posted : May 25, 2022
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)
|Condition or disease||Intervention/treatment||Phase|
|Cytoreductive Surgery Grade 3 Endometrial Endometrioid Adenocarcinoma High Grade Serous Carcinoma Endometrial Undifferentiated Carcinoma Endometrial Mixed Cell Adenocarcinoma||Combination Product: PET/MRI with radiotracer ([18F]- fluorodeoxyglucose) and a gadolinium-based contrast agent||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||October 2022|
|Estimated Primary Completion Date :||February 1, 2024|
|Estimated Study Completion Date :||February 1, 2026|
Experimental: PET/MRI IN ENDOMETRIAL CANCER
PET/MRI in one study visit of approximately four hours
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.
- Percentage of patients with a metastatic lesion noted on PET/MRI that have a true malignancy noted on surgical pathology of that lesion [ Time Frame: Baseline ]Sensitivity of PET/MRI to detect metastatic lesions
- Percentage of patients without any metastatic lesion noted on PET/MRI that do not have malignancy noted on surgical pathology [ Time Frame: Baseline ]Specificity of PET/MRI to detect abscence of metastatic lesions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05390021
|Contact: Onofrio Catalono, MD, PhD||(617) firstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02115|
|Contact: Onofrio Catalano, MD, Ph.D 617-643-7920 email@example.com|
|Principal Investigator: Onofrio Catalano, MD, Ph.D|
|Principal Investigator:||Onofrio Catalono, MD, PhD||Massachusetts General Hospital|