Tomosynthesis in Screening Mammography

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hologic, Inc.
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT01086241
First received: March 11, 2010
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

Tomosynthesis is a new digital mammographic tool which can be performed at the same time as routine screening mammography. It creates CT-like slices through the breast, minimizing the tissue overlap. Tomosynthesis has the potential to improve screening mammography outcomes by increasing cancer detection rates, decreasing false negative rates and false positive rates. This trial will help determine if tomosynthesis is useful in a screening setting.


Condition Intervention
Breast Density >25%
Procedure: 2D Mammogram
Procedure: Tomosynthesis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: A Study to Determine Patient Benefit of Tomosynthesis in Screening Mammography

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Interpretation Time of Scan [ Time Frame: Within 1 month of receiving scan ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recall Rates [ Time Frame: 6 month intervals for 2 years after initial scan ] [ Designated as safety issue: No ]
  • Discomfort Scale [ Time Frame: Immediately after the subject receives scan ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: May 2010
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A: routine 2D mammogram
Subject receives regular 2D mammogram.
Procedure: 2D Mammogram
Those patients randomized to the mammogram arm will receive a regular 2D mammogram. Compression lasts several seconds in order to obtain 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast.
Active Comparator: B: Routine Mammogram + tomosynthesis
Routine Mammogram and tomosynthesis
Procedure: Tomosynthesis
Those patients randomized to the tomosynthesis arm will receive a combination of 3D and 2D screening mammogram. The additional tomosynthesis data is obtained immediately after acquisition of the 2D study, with the patient and breast remaining in the same position and compression. Compression lasts about 7 seconds longer for each of the 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast.

Detailed Description:

We will evaluate the effect of tomosynthesis mammography outcomes in a screening setting. We will collect data on interpretation time, recall rates, cancer detection rates, and interval cancer rates in dense breasts(≥ 50% glandular density). If the interpretation time is less than 4X a routine read, and the recall rates have dropped < 30% of initial values, we will then conduct a study with larger numbers to better evaluate cancer detection rates and interval cancer rates.

  Eligibility

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females 40-69 years of age attending Screen Test Kingsway referred for a screening mammogram as defined by Canadian Cancer Society guidelines.
  • Prior mammogram report indicating ≥ 25% breast density.

Exclusion Criteria:

  • Prior mammogram report indicating <25% breast density.
  • Breast implants
  • Pregnancy
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086241

Locations
Canada, Alberta
Alberta Screen Test
Edmonton, Alberta, Canada
Sponsors and Collaborators
AHS Cancer Control Alberta
Hologic, Inc.
Investigators
Study Chair: Aalo Bistritz, MD Cross Cancer Institute
Principal Investigator: Aalo Bistritz, MD Cross Cancer Institute
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01086241     History of Changes
Other Study ID Numbers: DX-TOM-001 25232, DX-TOM-001 25232
Study First Received: March 11, 2010
Last Updated: October 25, 2013
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
Tomography
Mammography
Breast Neoplasms
Prevention and Control

ClinicalTrials.gov processed this record on September 18, 2014