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Efficacy of Tomosynthesis in the BIRADS 3 Population

This study has been completed.
Sponsor:
Collaborator:
Hologic, Inc.
Information provided by:
WellSpan Health
ClinicalTrials.gov Identifier:
NCT00763100
First received: September 26, 2008
Last updated: January 5, 2011
Last verified: January 2011
  Purpose

There are three main objectives, centering on those patients targeted for surveillance imaging. The first objective is to compare image quality and specificity of breast tomosynthesis and conventional 2D mammography in a BIRADS 3 diagnostic population. The second objective is to compare image quality and ability to determine post-surgical and post-radiation changes from recurrence in a post-cancer subset of a BIRADS 3 population having undergone conservation therapy (lumpectomy with or without radiation. The final objective is to compare image quality and the ability to determine chemoresponsiveness in a post-cancer subset of a BIRADS 3 population, who are undergoing neoadjuvant chemotherapy.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: The Efficacy of Tomosynthesis in the BIRADS 3 Population Including Surveillance of Patients in the Treatment or Post-Treatment for Breast Cancer

Resource links provided by NLM:


Further study details as provided by WellSpan Health:

Primary Outcome Measures:
  • to see if Breast Tomosynthesis, a three-dimensional (3D) imaging study is more accurate than standard mammography (a two-dimensional (2D) study). [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 690
Study Start Date: May 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast cancer
Patients in treatment or post-treatment for breast cancer

  Eligibility

Ages Eligible for Study:   26 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Three groups of patients will be enrolled:

Group 1 will enroll patients that have been categorized as a BIRADS 3 on the basis of screening and diagnostic conventional imaging work-up.

Group II will enroll patients that have been categorized as a BIRADS 3 for surveillance imaging because they have undergone breast conservation therapy for breast cancer.

Group III will enroll patients that have been categorized as a BIRADS 3 for surveillance imaging because they are currently undergoing primary systemic therapy.

Criteria

Inclusion Criteria:

GROUP 1

  • female of any race and ethnicity
  • 35 years or older
  • after routine and diagnostic imaging, subject is categorized as a BI-RADS 3 and will undergo study imaging within 30 days of routine or diagnostic imaging.
  • subject is returning for surveillance imaging after a categorization of a BI-RADS 3 and will undergo study imaging within 30 days of surveillance imaging GROUP 2
  • female of any race and ethnicity
  • 26 years or older
  • subject has completed cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging
  • subject will undergo study imaging within 30 days of surveillance imaging GROUP 3
  • female of any race and ethnicity
  • 26 years or older
  • subject is currently undergoing cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging OR
  • subject will undergo study imaging within 30 days of surveillance imaging

Exclusion Criteria:

  • GROUP 1, 2 and 3
  • subjects unable or unwilling to participate
  • subjects who are unable or unwilling to tolerate compression
  • subjects who are pregnant or who think they may be pregnant
  • subjects who are breastfeeding
  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: NCT00763100

Sponsors and Collaborators
WellSpan Health
Hologic, Inc.
Investigators
Principal Investigator: Joanne Trapeni, DO WellSpan Health
  More Information

No publications provided

Responsible Party: Joanne Trapeni, DO, Women's Imaging Center
ClinicalTrials.gov Identifier: NCT00763100     History of Changes
Other Study ID Numbers: 0708023
Study First Received: September 26, 2008
Last Updated: January 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by WellSpan Health:
Breast cancer
Three dimensional versus two dimensional
Breast cancer surveillance
Tomosynthesis

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

ClinicalTrials.gov processed this record on November 27, 2014