Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments tomosynthesis, standard mammography
Sponsor Massachusetts General Hospital
Collaborator Hologic, Inc.
Start date November 2007
End date October 2012
Trial size 600 participants
Trial identifier NCT01669148, 2007p-001197

Summary

The primary hypothesis to be tested is:

Detection of breast cancer will be increased with tomosynthesis (3D) imaging.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
standard mammography
standard mammography
(Experimental)
tomosynthesis
tomosynthesis
The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).
standard mammography

Primary Outcomes

Measure
image quality
time frame: concurrent assessment of image quality with up to two year follow up for development of breast cancer

Eligibility Criteria

Female participants at least 35 years old.

Inclusion Criteria: - Female - Any ethnic origin - No contraindication for routine bilateral mammography Exclusion Criteria: Potential subjects with any of the following will not be enrolled in the study: - Any contraindications to mammographic screening, including, but not limited to: - Significant existing breast trauma - Under the age of 30 at the time of consent - Breast Implants - Prior Surgeries - Unable to understand and execute written informed consent - Pregnant - Lactating

Additional Information

Official title Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography
Principal investigator Elizabeth A Rafferty, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.