MRI to Detect Breast Tumors in Women

NCT00003302 | Completed

• 2 other identifiers: CDR0000066242UPCC-ACR-6883
• Study Type: interventional
• Target: 1,500
• Locations: 3 countries
• Sites: 15

Brief Summary

RATIONALE: New imaging procedures, such as MRI, may improve the ability to detect breast tumors. PURPOSE: Diagnostic study to determine the value of MRI in detecting breast tumors in women who have had suspicious mammographic or clinical examinations.

Conditions

Breast Cancer

Keywords

breast cancer

Interventions

biopsy PROCEDURE

magnetic resonance imaging DIAGNOSTIC_TEST

mammography DIAGNOSTIC_TEST

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Suspicious mammographic finding or palpable abnormality OR Suspicious clinical or ultrasound finding without associated benign mammographic features May have more than one suspicious lesion based on mammography or clinical exam if an index lesion is present Mammogram within 2 months prior to MRI scan and copy of films required of all patients 30 years of age and over Eligibility maintained if patient meets above criteria and has had: Breast implant Prior benign excisional or core biopsy at least 6 months prior to study Fine needle aspiration performed at any time Cancer in the contralateral breast No history of prior breast cancer in the study breast No benign excisional or core biopsy of the affected breast within the last 6 months PATIENT CHARACTERISTICS: Age: 18 to 79 Sex: Women Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No implanted pacemaker Other: No implanted ferromagnetic device No ferromagnetic aneurysm clip No severe claustrophobia No ocular metal fragments No shrapnel injury No difficulty lying prone No poor venous access No impaired decision-making abilities Not pregnant PRIOR CONCURRENT THERAPY: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (15)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21231-2410, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University of Toronto

Toronto, Ontario, M5S 1A8, Canada

Location

Universitaetskliniken Bonn

Bonn, D-53127, Germany

Location

Martin Luther Universitaet

Halle, DOH-0-6112, Germany

Location

Related Publications (3)

• Schnall MD, Blume J, Bluemke DA, DeAngelis GA, DeBruhl N, Harms S, Heywang-Kobrunner SH, Hylton N, Kuhl CK, Pisano ED, Causer P, Schnitt SJ, Thickman D, Stelling CB, Weatherall PT, Lehman C, Gatsonis CA. Diagnostic architectural and dynamic features at breast MR imaging: multicenter study. Radiology. 2006 Jan;238(1):42-53. doi: 10.1148/radiol.2381042117.

  PMID: 16373758 RESULT

• Schnall MD, Blume J, Bluemke DA, Deangelis GA, Debruhl N, Harms S, Heywang-Kobrunner SH, Hylton N, Kuhl CK, Pisano ED, Causer P, Schnitt SJ, Smazal SF, Stelling CB, Lehman C, Weatherall PT, Gatsonis CA. MRI detection of distinct incidental cancer in women with primary breast cancer studied in IBMC 6883. J Surg Oncol. 2005 Oct 1;92(1):32-8. doi: 10.1002/jso.20381.

  PMID: 16180227 RESULT

• Bluemke DA, Gatsonis CA, Chen MH, DeAngelis GA, DeBruhl N, Harms S, Heywang-Kobrunner SH, Hylton N, Kuhl CK, Lehman C, Pisano ED, Causer P, Schnitt SJ, Smazal SF, Stelling CB, Weatherall PT, Schnall MD. Magnetic resonance imaging of the breast prior to biopsy. JAMA. 2004 Dec 8;292(22):2735-42. doi: 10.1001/jama.292.22.2735.

  PMID: 15585733 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy; Magnetic Resonance Imaging; Mammography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Tomography; Diagnostic Imaging; Radiography

Study Officials

• Mitchell Schnall, PhD

  Abramson Cancer Center at Penn Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 1, 2004
• Study Start: May 1, 1998
• Primary Completion: June 30, 2000
• Study Completion: June 30, 2000
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

US (12); DE (2); CA (1)