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

Breast Cancer Clinical Trial

— MRI-PEM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02426489
• Other study ID #: WMP-2
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2015
• Est. completion date: May 8, 2016

Study information

• Verified date: October 2021
• Source: Weinberg Medical Physics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 8, 2016
• Est. primary completion date: May 8, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Female over 21 years of age;

• with a suspicious lesion found in the breast and recommended for biopsy or have a confirmed diagnosis of cancer;

• and in good health (other than having breast lesions);

• and can lie still in a prone position for 30 minutes in an MRI scanner.

Exclusion Criteria:

• Pregnancy;

• unwilling to give informed consent;

• have implanted prosthetic heart valve,

• pacemaker,

• neurostimulator,

• surgical clips or other metallic implants;

• have engaged in occupations or received orthodontic work which may have caused lodging of ferromagnetic materials in the body;

• are claustrophobic;

• have been allergic to contrast agents;

• are diabetic;

• or have a history of kidney disease.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• MRI + PEM image
Effect of positron emission mammography on diagnostic accuracy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Weinberg Medical Physics LLC	University of California, Irvine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of combination MRI/positron emission mammography (diagnostic accuracy, defined as the number of correct assessments divided by the number of all assessments)	Patients with benign disease on biopsy may be followed for up to 2 years after imaging	up to 2 years