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

NCT02426489 | Terminated

• 1 other identifier: WMP-2
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Diagnostic accuracy with MRI alone

NO INTERVENTION

The MRI of the breast lesion will be examined. Measures of performance accuracy will be evaluated, including diagnostic sensitivity (true positives divided by true positives and false negatives), diagnostic specificity (true negatives divided by true negatives and false positives), and diagnostic accuracy, defined as the number of correct assessments divided by the number of all assessments.

Diagnostic accuracy with MRI + PEM image

EXPERIMENTAL

The combined PEM/MRI image will be examined.

Device: MRI + PEM image

Interventions

MRI + PEM image DEVICE

Effect of positron emission mammography on diagnostic accuracy

Also known as: flurodeoxyglucose

Diagnostic accuracy with MRI + PEM image

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weinberg Medical Physics LLC: lead
• University of California, Irvine: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Irving Weinberg, MD PhD

  Weinberg Medical Physics LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: April 27, 2015
• Study Start: July 1, 2015
• Primary Completion: May 8, 2016
• Study Completion: May 8, 2016
• Last Updated: October 7, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share