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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Gamma Medica, Inc.
Sponsor:
Information provided by (Responsible Party):
Gamma Medica, Inc.
ClinicalTrials.gov Identifier:
NCT02013726
First received: December 9, 2013
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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. 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. 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. Combining the use of MBI and breast tomosynthesis will provide performance superior to either technology alone, as manifest by a superior ROC curve area.

Condition Intervention
Breast Neoplasms
Device: MBI Scan: The LumaGEM®
Device: 3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions®

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study: Dedicated Dual Head Molecular Breast Imaging Compared to Breast Tomosynthesis for Evaluation of Patients With Type 3 or 4 Mammographic Breast Density.

Resource links provided by NLM:


Further study details as provided by Gamma Medica, Inc.:

Primary Outcome Measures:
  • Sensitivity/Cancer detection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Sensitivity being the number of scans read or labeled positive (by radiologist) divided by the total cancers confirmed by pathology results (i.e. biopsy).


Secondary Outcome Measures:
  • Specificity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Specificity being the total number of scans read or labeled as negative (by a radiologist) divided by number of total women without cancer. This "ground truth" of a true negative will involve in a second negative imaging scan at 12 months (follow-up exam).


Estimated Enrollment: 200
Study Start Date: April 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MBI Scan & Tomosynthesis Scan
Patients will receive both scans.
Device: MBI Scan: The LumaGEM®
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.
Device: 3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions®
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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Gamma Medica, Inc.
ClinicalTrials.gov Identifier: NCT02013726     History of Changes
Other Study ID Numbers: GMI_Sc-02
Study First Received: December 9, 2013
Last Updated: December 23, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 01, 2014