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MRI for Detecting Cancer in Women Who Are at High Risk of Developing Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
motexafin gadolinium
biopsy
breast imaging study
comparison of screening methods
magnetic resonance imaging
study of high risk factors
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring breast cancer

Eligibility Criteria

25 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Patients at greater than 25% lifetime risk for breast cancer on the basis of family history or a genetic test Prior breast cancer allowed if patient meets the greater than 25% lifetime risk Patients with greater than 5 years since diagnosis must have at least 50% probability for developing breast cancer by the Couch model or be positive for BRCA1 or BRCA2 mutation Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 25 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No contraindications to MRI scan including patients with pacemakers, magnetic aneurysm clips or other implanted magnetic devices, or severe claustrophobia Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Sites / Locations

  • UCSF Cancer Center and Cancer Research Institute
  • University of Colorado Cancer Center
  • Porter Adventist Hospital
  • Hartford Hospital
  • Lombardi Cancer Center
  • Roswell Park Cancer Institute
  • Lineberger Comprehensive Cancer Center, UNC
  • University of Pennsylvania Cancer Center
  • Simmons Cancer Center - Dallas
  • Cancer Center at the University of Virginia
  • University of Washington Medical Center
  • University of Toronto

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
September 23, 2019
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003736
Brief Title
MRI for Detecting Cancer in Women Who Are at High Risk of Developing Breast Cancer
Official Title
Pilot Study: High Risk Breast Cancer Screening Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
June 2002 (Actual)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for breast cancer. Diagnostic procedures such as MRI may improve the ability to detect breast cancer. PURPOSE: Screening and diagnostic trial to study the effectiveness of MRI scans in women who are at high risk for developing breast cancer.
Detailed Description
OBJECTIVES: Estimate the diagnostic yield and positive predictive value of breast magnetic resonance imaging (MRI) for the detection of cancer in women who are at greater than 25% lifetime risk for developing breast cancer. Compare the diagnostic yield and positive predictive value of MRI with conventional breast cancer screening (mammography and physical examination) for the detection of breast cancer in women with a greater than 25% lifetime risk of developing breast cancer. OUTLINE: All patients receive a physical exam within 90 days of initial MRI scan. Patients undergo a two view screening mammogram within 3 months prior to study entry. Patients undergo an MRI with gadolinium contrast at entry. All lesions identified as suspicious on physical examination, mammography, or MRI undergo a core needle or excisional biopsy. PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
motexafin gadolinium
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Type
Procedure
Intervention Name(s)
breast imaging study
Intervention Type
Procedure
Intervention Name(s)
comparison of screening methods
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
study of high risk factors

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Patients at greater than 25% lifetime risk for breast cancer on the basis of family history or a genetic test Prior breast cancer allowed if patient meets the greater than 25% lifetime risk Patients with greater than 5 years since diagnosis must have at least 50% probability for developing breast cancer by the Couch model or be positive for BRCA1 or BRCA2 mutation Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 25 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No contraindications to MRI scan including patients with pacemakers, magnetic aneurysm clips or other implanted magnetic devices, or severe claustrophobia Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Schnall, PhD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0128
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102-5037
Country
United States
Facility Name
Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Simmons Cancer Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9154
Country
United States
Facility Name
Cancer Center at the University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6043
Country
United States
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1A8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16180217
Citation
Lehman CD, Blume JD, Thickman D, Bluemke DA, Pisano E, Kuhl C, Julian TB, Hylton N, Weatherall P, O'loughlin M, Schnitt SJ, Gatsonis C, Schnall MD. Added cancer yield of MRI in screening the contralateral breast of women recently diagnosed with breast cancer: results from the International Breast Magnetic Resonance Consortium (IBMC) trial. J Surg Oncol. 2005 Oct 1;92(1):9-15; discussion 15-6. doi: 10.1002/jso.20350.
Results Reference
result
PubMed Identifier
15800894
Citation
Lehman CD, Blume JD, Weatherall P, Thickman D, Hylton N, Warner E, Pisano E, Schnitt SJ, Gatsonis C, Schnall M, DeAngelis GA, Stomper P, Rosen EL, O'Loughlin M, Harms S, Bluemke DA; International Breast MRI Consortium Working Group. Screening women at high risk for breast cancer with mammography and magnetic resonance imaging. Cancer. 2005 May 1;103(9):1898-905. doi: 10.1002/cncr.20971.
Results Reference
result

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MRI for Detecting Cancer in Women Who Are at High Risk of Developing Breast Cancer

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