MBI and Breast Tomosynthesis Screening Accuracies in Patients With Dense Breast Tissue

NCT02013726 | Withdrawn

• 1 other identifier: GMI_Sc-02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary: In women with heterogeneous or dense breast tissue (mammographic types 3 and 4), MBI (Molecular Breast Imaging) will detect more breast cancers and have greater sensitivity in detecting breast cancer than breast tomosynthesis. Secondary:

1. 1.In women with heterogeneous or dense breast tissue, the specificity of MBI in correctly classifying subjects without breast cancer will be non-inferior to breast tomosynthesis.
2. 2.In women with heterogeneous or dense breast tissue, the area under the receiver operating characteristic (ROC) curve for MBI will be non-inferior or superior to breast tomosynthesis.
3. 3.Combining the use of MBI and breast tomosynthesis will provide performance superior to either technology alone, as manifest by a superior ROC curve area.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Sensitivity/Cancer detection

  Sensitivity being the number of scans read or labeled positive (by radiologist) divided by the total cancers confirmed by pathology results (i.e. biopsy).

  12 months

Secondary Outcomes (1)

• Specificity

  12 months

Study Arms (1)

MBI Scan & Tomosynthesis Scan

EXPERIMENTAL

Patients will receive both scans.

Device: MBI Scan: The LumaGEM®; Device: 3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions®

Interventions

MBI Scan: The LumaGEM® DEVICE

The LumaGEM Scanner is a dual-head, MBI scanner that has previously been cleared for medical marketing (510(k) number K111791), and has been used to image more than 5,000 patients to date. The LumaGEM MBI scanner is used as a diagnostic adjunct to mammography screening for problem cases The efficacy of MBI has been well documented in clinical trials. The LumaGEM MBI scanner is a dual-head, small field-of-view (FOV) device for developing an MBI image of Tc99m-Sestamibi uptake within the breast. The device consists of solid-state detectors, a data acquisition system, and a computer. The detectors are also used to immobilize the breast during image acquisition by mild compression. The detectors are housed in two heads that are positioned on both sides of a compressed breast.

MBI Scan & Tomosynthesis Scan

3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions® DEVICE

The breast tomosynthesis procedure involves x-ray imaging of the breast using a moving x-ray source and digital detectors composed of cesium iodide crystals on an amorphous silicon layer or of solely selenium in order to produce an image of the breast. This procedure is considered to basically be a modification of mammography and also is used as a diagnostic adjunct to mammography screening for problem cases.

MBI Scan & Tomosynthesis Scan

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over 25 years of age with normal or increased risk of breast cancer.
• Women with type 3 or 4 breast density as determined by a breast imaging radiologist on a current unilateral (women with prior mastectomy) or bilateral mammography (within prior 6 weeks).
• No contraindications to breast MBI or breast tomosynthesis.

You may not qualify if:

• Women under the age of 25.
• Women who are or may be pregnant.
• Women who are currently lactating or have discontinued breast feeding \< 2 months prior to the study.
• Male patients are excluded as subjects.
• Those unable or unwilling to provide informed consent.

Sponsors & Collaborators

• Gamma Medica, Inc.: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 17, 2013
• Study Start: April 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 25, 2014

Record last verified: 2014-08