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Role of 3D Tomography in Breast Cancer

This study is currently recruiting participants.
Verified November 2012 by University of Rochester
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01090687
First received: February 22, 2010
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

The primary aim of this pilot study is to define the role of dedicated cone beam breast computed tomography in breast cancer imaging. This research is a prelude of a more comprehensive clinical trial that may follow.


Condition Intervention Phase
Breast Cancer
 Radiation: computed tomography (CT scan)
Device: computed tomography (CT scan)
 Phase 1
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of 3D Tomography in Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Correlation between mammography and breast CT on lesion detection [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    There are two specific aims of this pilot study. One specific aim is to determine if the lesions that are detected by mammography and referred for biopsy, are visible with breast CT. The other specific aim is to determine if there is a correlation between CT numbers and malignancy, in particular for soft tissue (solid masses) abnormalities and to determine if image processing techniques improve correlation between CT numbers and malignancy.


Estimated Enrollment: 150
Study Start Date: March 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group I Microcalcifications
After classification as BI-RADS 4/5, approximately 75 to 100 subjects with primary findings based on microcalcifications will be recruited to have a breast CT scan.
 Radiation: computed tomography (CT scan)
Subjects will undergo cone beam breast CT scan
Other Name: CT scan
Group II Soft tissue findings
After classification as BI-RADS 4/5, approximately 75 to 100 subjects with primary soft tissue findings, with or without associated microcalcifications, will be recruited to have a breast CT scan.
 Device: computed tomography (CT scan)
Subjects will undergo cone beam breast CT scan
Other Name: CT scan

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women, age 40 or older, who are scheduled for biopsy after classification as BI-RADS 4/5 and have had a screening or diagnostic full-field digital mammography (FFDM) exam, and who meet the inclusion criteria, are eligible to participate.

Criteria

Inclusion Criteria:

  • All women, age 40 or older, who are scheduled for biopsy after classification as BI-RADS 4/5 and have had a screening or diagnostic full-field digital mammography (FFDM) exam are eligible to participate, except for exclusions noted below.
  • Able to provide informed consent.

Exclusion Criteria:

  • Males
  • Women less than 40 years old
  • Pregnant women
  • Lactating women
  • Woman who have had bilateral mastectomies
  • Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker
  • Women who are unable to tolerate study constraints, frail or unable to cooperate
  • Women with large breasts that cannot be accommodated within the field of view of the CT system

  • Women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)

    • Treatment for enlarged thymus gland as an infant
    • Irradiation for benign breast conditions, including breast inflammation after giving birth
    • Treatment for Hodgkin's disease
  • Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.

  • Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

    • Tuberculosis
    • Severe scoliosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090687

Contacts
Contact: Avice O'Connell, MD 585-487-3319 avice_oconnell@urmc.rochester.edu

Locations
United States, New York
University of Rochester Medical Center, Highland Breast Imaging Center Recruiting
Rochester, New York, United States, 14623
Principal Investigator: Avice O'Connell, MD            
Sponsors and Collaborators
University of Rochester
National Cancer Institute (NCI)
Investigators
Principal Investigator: Andrew Karellas, PhD University of Massachusetts, Worcester
Principal Investigator: Stephen Glick, PhD University of Massachusetts, Worcester
  More Information

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT01090687     History of Changes
Other Study ID Numbers: URMC-UMASS, 1R21CA134128-01A2
Study First Received: February 22, 2010
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
breast cancer, CT scans, mammography

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

ClinicalTrials.gov processed this record on May 19, 2013