NCT02426489

Improving Diagnosis of Breast Cancer by Using a Combined MRI and Positron Emission Mammography (MRI-PEM) System

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Weinberg Medical Physics LLC · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess whether the addition of positron emission mammography will add diagnostic value to magnetic resonance imaging of the breast, in patients with lesions of the breast that are suspicious enough to warrant biopsy, or which have been confirmed as containing cancer cells.

Detailed description

70 eligible subjects will be asked to undergo contrast-enhanced MRI studies of the breast containing the lesion. Subjects will be asked to fast for 6 hours prior to the imaging session. Each subject will be tested for glucose, and if the glucose is not too high, the subject will be injected with a dose of radioactive sugar (fluoro-deoxyglucose) which has been shown in other studies to accumulate in breast cancers. The subject will be asked to sit quietly for 30 minutes and to empty the bladder. The subject will then be asked to be re-examined in the MRI scanner with MRI contrast injection. The examination bed will be moved out of the MRI scanner and detectors of the radioactive sugar will be placed near the breast in order to obtain a positron emission mammogram for a 10-minute period. The subject will then leave the MRI suite.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	MRI + PEM image	Effect of positron emission mammography on diagnostic accuracy

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-05-08
• Completion: 2016-05-08
• First posted: 2015-04-27
• Last updated: 2021-10-07