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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

February 22, 2010
November 1, 2012
March 2010
November 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01090687 on ClinicalTrials.gov Archive Site
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Role of 3D Tomography in Breast Cancer
Role of 3D Tomography in Breast Cancer

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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.
Breast Cancer
  • Radiation: computed tomography (CT scan)
    Subjects will undergo cone beam breast CT scan
    Other Name: CT scan
  • Device: computed tomography (CT scan)
    Subjects will undergo cone beam breast CT scan
    Other Name: CT scan
  • 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.
    Intervention: Radiation: computed tomography (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.
    Intervention: Device: computed tomography (CT scan)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2012
November 2012   (final data collection date for primary outcome measure)

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
Female
40 Years and older
No
Contact: Avice O'Connell, MD 585-487-3319 avice_oconnell@urmc.rochester.edu
United States
 
NCT01090687
URMC-UMASS, 1R21CA134128-01A2
Yes
University of Rochester
University of Rochester
National Cancer Institute (NCI)
Principal Investigator: Andrew Karellas, PhD University of Massachusetts, Worcester
Principal Investigator: Stephen Glick, PhD University of Massachusetts, Worcester
University of Rochester
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP