Breast CancerNCT00003302
MRI to Detect Breast Tumors in Women
A study testing biopsy, magnetic resonance imaging and mammography in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 15 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- biopsy, magnetic resonance imaging and mammography
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 15 sitesin 3 countries
- Study dates
- May 1998to 30 Jun 2000
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States12 sites
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231-2410
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
University of Colorado Cancer Center
Denver, Colorado, 80010
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
Germany2 sites
Universitaetskliniken Bonn
Bonn, D-53127
Martin Luther Universitaet
Halle, DOH-0-6112
About this study
Official title: Breast MRI Protocol
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.
Read the detailed description
OBJECTIVES: I. Evaluate the performance of breast magnetic resonance imaging (MRI) in conjunction with mammography for the detection and characterization of lesions in women with suspicious mammographic or clinical examinations. II. Assess the incremental value of breast MRI to determine the local extent of cancer in these patients. III. Assess the value of breast MRI to determine the prevalence and characteristics of incidental enhancing lesions in the remainder of the breast.
OUTLINE: This is a multicenter study. Patients undergo a high resolution 3D post contrast magnetic resonance imaging (MRI) scan. Patients with enhancing abnormalities undergo a dynamic scan no less than 18 hours later. Some patients may require a third scan if a core biopsy is to be performed. Patients who are ultimately found to have cancer are assessed for extent of cancer including measurement of the index lesion and identification of other present foci of cancer in relation to the index lesion. Further histological diagnosis of index lesions is determined by MRI-guided needle localization excisional biopsy. Patients with benign needle biopsy are followed for 2 years. Patients with benign primary lesions receive a follow up MRI scan 1 year after the initial scan. Patients with benign primary lesions and incidental enhancing lesions (IEL) are followed at 2 years. Patients with negative needle biopsies not yielding a specific diagnosis and who do not undergo subsequent excisional biopsy are followed yearly for 2 years.
PROJECTED ACCRUAL: A total of 1500 patients will be accrued for this study over 4.25 years.
- Conditions
- Breast Cancer
- Being tested
- biopsy, magnetic resonance imaging, mammography
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyProcedure or surgery
magnetic resonance imagingDiagnostic test
mammographyDiagnostic test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2004 (estimated)
- Study startMay 1998
- Primary completion30 Jun 2000
- Study completion30 Jun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mitchell Schnall, PhD, Study chair, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003302
- Sponsor's protocol ID
- CDR0000066242
- Other IDs
- UPCC-ACR-6883
- Status last verified
- Sep 2019
- First submitted
- 1 Nov 1999
- Last updated
- 25 Sep 2019
- Results posted
- No
Publications
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.
PubMed 16373758Schnall 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.
PubMed 16180227Bluemke 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.
PubMed 15585733
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast MRI Protocol
- ClinicalTrials.gov ID
- NCT00003302
- Acronym / sponsor ID
- CDR0000066242
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1998
- Primary completion
- 30 Jun 2000 (actual)
- Study completion
- 30 Jun 2000
- First posted
- 1 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES: I. Evaluate the performance of breast magnetic resonance imaging (MRI) in conjunction with mammography for the detection and characterization of lesions in women with suspicious mammographic or clinical examinations. II. Assess the incremental value of breast MRI to determine the local extent of cancer in these patients. III. Assess the value of breast MRI to determine the prevalence and characteristics of incidental enhancing lesions in the remainder of the breast.
OUTLINE: This is a multicenter study. Patients undergo a high resolution 3D post contrast magnetic resonance imaging (MRI) scan. Patients with enhancing abnormalities undergo a dynamic scan no less than 18 hours later. Some patients may require a third scan if a core biopsy is to be performed. Patients who are ultimately found to have cancer are assessed for extent of cancer including measurement of the index lesion and identification of other present foci of cancer in relation to the index lesion. Further histological diagnosis of index lesions is determined by MRI-guided needle localization excisional biopsy. Patients with benign needle biopsy are followed for 2 years. Patients with benign primary lesions receive a follow up MRI scan 1 year after the initial scan. Patients with benign primary lesions and incidental enhancing lesions (IEL) are followed at 2 years. Patients with negative needle biopsies not yielding a specific diagnosis and who do not undergo subsequent excisional biopsy are followed yearly for 2 years.
PROJECTED ACCRUAL: A total of 1500 patients will be accrued for this study over 4.25 years.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsy | Procedure or surgery | – |
| magnetic resonance imaging | Diagnostic test | – |
| mammography | Diagnostic test | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Results publication: PubMed 16373758Schnall 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.
- Results publication: PubMed 16180227Schnall 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.
- Results publication: PubMed 15585733Bluemke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Schnall, PhD study chair
Abramson Cancer Center at Penn Medicine
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsy, magnetic resonance imaging and mammography in people with Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 15 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Germany, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003302, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.