Breast CancerACRIN-6667NCT00058058

Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer

A study testing MRI in people with Breast Cancer and Contralateral Breast Cancer, run by American College of Radiology Imaging Network at 21 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may improve the ability to detect cancer in the unaffected breast of women recently diagnosed with unilateral breast cancer. Read more about this study

Who is it for?: Ages 18 to 120 years, women only
Conditions the study is for: Breast Cancer, Contralateral Breast Cancer
What is being tested?: MRI
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,007 participants
Where: 21 sitesin 3 countries
Study dates: Feb 2003to Aug 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 120 years
Women only
No healthy volunteers
Adult, Older adult

DISEASE CHARACTERISTICS:

Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast
Confirmed by biopsy or fine needle aspiration (FNA) within the past 60 days
Negative or benign mammogram (BI-RADS assessment 1 or 2) and negative or benign clinical breast exam of the contralateral breast within the past 90 days
Prior biopsy of the contralateral breast (including FNA) is allowed provided it was performed at least 6 months prior to study entry
Prior magnetic resonance exam of the contralateral breast is allowed provided it was performed at least 1 year prior to study entry
No remote history of breast cancer
No new breast symptoms within the past 60 days for which further evaluation is recommended
Hormone receptor status:
Not specified

PATIENT CHARACTERISTICS:

Age

18 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

Cardiovascular

No pacemaker
No magnetic aneurysm clips

Other

Not pregnant
No implanted magnetic device
No severe claustrophobia
No other contraindications to MRI
No psychiatric, psychological, or other condition that would preclude informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

At least 6 months since prior anticancer chemotherapy

Endocrine therapy

No concurrent therapeutic hormonal therapy, tamoxifen, or aromatase inhibitors (preventive therapy allowed)

Radiotherapy

Not specified

Surgery

Not specified

Trial locations and contacts

21 sites in 3 countries.

Country

City, postcode or hospital

21 sites in 3 countries

United States19 sites

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287-6681
Boca Raton Community Hospital
Boca Raton, Florida, 33486
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60610
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267-0772
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390-9085
Porter Adventist Hospital
Denver, Colorado, 80210
Hartford Hospital
Hartford, Connecticut, 06102-5037
Mayo Clinic
Jacksonville, Florida, 32224
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104-4283
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Memorial Medical Center
Springfield, Illinois, 62781
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307

Other trials in United States

Canada1 site

University of Toronto
Toronto, Ontario, M5S 1A8

Other trials in Canada

Germany1 site

Universitaetsklinikum Bonn
Bonn, D-53105

Other trials in Germany

About this study

Official title: MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer

RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may improve the ability to detect cancer in the unaffected breast of women recently diagnosed with unilateral breast cancer.

PURPOSE: Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected breast of women recently diagnosed with unilateral breast cancer.

Read the detailed description

OBJECTIVES:

Determine the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam.
Determine the sensitivity, specificity, positive predictive value for both call backs for additional imaging and biopsy recommendations, and receiver operating characteristic curves of MRI in evaluating these patients.
Determine the effect of the following patient-related factors: age (50 years old and over vs less than 50 years old), breast parenchymal density (fatty vs non fatty breast), and tumor histology (invasive lobular vs invasive ductal, invasive vs in situ) on the performance of MRI (cancer yield, sensitivity, specificity, and PPV).

OUTLINE: This is a multicenter study.

Patients receive gadopentetate dimeglumine IV and then undergo magnetic resonance imaging of the contralateral breast.

Patients are followed at 12-18 and 24-30 months.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

Conditions: Breast Cancer, Contralateral Breast Cancer
Being tested: MRI
Keywords: ductal breast carcinoma in situ, invasive ductal breast carcinoma, invasive lobular breast carcinoma, breast cancer in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, Magnetic resonance imaging, MRI
Medical subject headings: Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Ductal, Breast, Carcinoma, Lobular, Breast Carcinoma In Situ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MRIProcedure or surgery
Also called magnetic resonance imaging
Breast contralateral to the breast diagnosed with cancer was scanned prior to initiation of chemotherapy and within 90 days of a negative mammogram of the study breast. A recent (within 90 days) negative or benign mammogram (defined by final BI RADS category 1 or 2) and negative or benign clinical breast exam of the study breast were required for entry into the study.

Study groups in NCT00058058
Study group	Role	What they receive
MRI Evaluation of Contralateral Breast	Experimental	The cohort is a distinct population of women at high risk for breast carcinoma: women with a recent (within 60 days) personal diagnosis of breast cancer who will have MRI to evaluate the contralateral breast. Receives: Procedure: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

MRI Diagnostic Yield of Cancers in the Contralateral Breast
To assess the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam.
the "Test" status was defined based on combinations of the following 4 factors:
1. The initial BI-RADs: from the MRI of the contralateral breast
2. The final BI-RADs: determined after all subsequent work-up and follow-up within 365 from the initial MRI (an explicit recommendation for biopsy always resulted in a final BI-RADs of 4).
3. Subsequent work-up includes all procedures resultant from an Initial MRI finding (generally triggered by a BI-RADs 0 or 3) within 365 from the initial MRI
4. Whether or not biopsy procedure (Bx) were performed on the contralateral (Study) breast within 365 from the initial MRI
Measured: within 90 days of a negative mammogram of the study breast

Secondary outcomes (2)

MRI Detection of Cancer in the Contralateral Breast for the Estimation of Diagnostic Accuracy
Accuracy values (Sensitivity, Specificity, Positive Predicative Value (PPV), Negative Predictive Value (NPV), Diagnostic Yield, and Area Under the Curve (AUC)) of MRI in evaluating the contralateral breast of women with recent personal diagnosis of breast cancer will be determine from the reference standard (a diagnosed cancer in the study breast) and the Test result defined as either the Probability of malignancy from the initial MRI interpretation (for AUC) or the "Final BI-RADs", where the final BI-RADS is defined as the BI-RADS assigned after all subsequent work-up and follow-up within 365 from the initial MRI are complete (an explicit recommendation for biopsy always results in a final BI-RADs of 4).
Measured: within 90 days of a negative mammogram of the study breast
AUC as a Measure of the Accuracy of MRI for the Detection of Cancer in the Contralateral Breast
Area Under the Curve (AUC) of MRI in evaluating the contralateral breast of women with recent personal diagnosis of breast cancer will be determine from the reference standard (a diagnosed cancer in the study breast) and the Test result defined as the Probability of malignancy from the initial MRI interpretation.
Measured: within 90 days of a negative mammogram of the study breast

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2003Aug 2008

First posted9 Apr 2003 (estimated)
Study startFeb 2003
Primary completion8 Aug 2006
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
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
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,007 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00058058
Sponsor's protocol ID: CDR0000285698
Other IDs: ACRIN-6667, U01CA079778, U01CA080098
Acronym: ACRIN-6667
Status last verified: Jul 2019
First submitted: 7 Apr 2003
Last updated: 16 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

DeMartini WB, Hanna L, Gatsonis C, Mahoney MC, Lehman CD. Evaluation of tissue sampling methods used for MRI-detected contralateral breast lesions in the American College of Radiology Imaging Network 6667 trial. AJR Am J Roentgenol. 2012 Sep;199(3):W386-91. doi: 10.2214/AJR.11.7000.
PubMed 22915431
Weinstein SP, Hanna LG, Gatsonis C, Schnall MD, Rosen MA, Lehman CD. Frequency of malignancy seen in probably benign lesions at contrast-enhanced breast MR imaging: findings from ACRIN 6667. Radiology. 2010 Jun;255(3):731-7. doi: 10.1148/radiol.10081712.
PubMed 20501712
Lehman CD, Gatsonis C, Kuhl CK, Hendrick RE, Pisano ED, Hanna L, Peacock S, Smazal SF, Maki DD, Julian TB, DePeri ER, Bluemke DA, Schnall MD; ACRIN Trial 6667 Investigators Group. MRI evaluation of the contralateral breast in women with recently diagnosed breast cancer. N Engl J Med. 2007 Mar 29;356(13):1295-303. doi: 10.1056/NEJMoa065447. Epub 2007 Mar 28.
PubMed 17392300

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer
ClinicalTrials.gov ID: NCT00058058
Acronym / sponsor ID: ACRIN-6667 / CDR0000285698
Conditions: Breast Cancer, Contralateral Breast Cancer
Keywords: ductal breast carcinoma in situ, invasive ductal breast carcinoma, invasive lobular breast carcinoma, breast cancer in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,007 participants (actual)
Lead sponsor: American College of Radiology Imaging NetworkResearch network
Collaborators: National Cancer Institute (NCI)
Study start: Feb 2003 (actual)
Primary completion: 8 Aug 2006 (actual)
Study completion: Aug 2008 (actual)
First posted: 9 Apr 2003 (estimated)
Results: Posted 27 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may improve the ability to detect cancer in the unaffected breast of women recently diagnosed with unilateral breast cancer.

PURPOSE: Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected breast of women recently diagnosed with unilateral breast cancer.

Detailed description

OBJECTIVES:

Determine the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam.
Determine the sensitivity, specificity, positive predictive value for both call backs for additional imaging and biopsy recommendations, and receiver operating characteristic curves of MRI in evaluating these patients.
Determine the effect of the following patient-related factors: age (50 years old and over vs less than 50 years old), breast parenchymal density (fatty vs non fatty breast), and tumor histology (invasive lobular vs invasive ductal, invasive vs in situ) on the performance of MRI (cancer yield, sensitivity, specificity, and PPV).

OUTLINE: This is a multicenter study.

Patients receive gadopentetate dimeglumine IV and then undergo magnetic resonance imaging of the contralateral breast.

Patients are followed at 12-18 and 24-30 months.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MRI Evaluation of Contralateral Breast	Experimental	Procedure: MRIThe cohort is a distinct population of women at high risk for breast carcinoma: women with a recent (within 60 days) personal diagnosis of breast cancer who will have MRI to evaluate the contralateral breast.

Who may qualify

Ages: 18 to 120 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
MRIAlso: magnetic resonance imagingBreast contralateral to the breast diagnosed with cancer was scanned prior to initiation of chemotherapy and within 90 days of a negative mammogram of the study breast. A recent (within 90 days) negative or benign mammogram (defined by final BI RADS category 1 or 2) and negative or benign clinical breast exam of the study breast were required for entry into the study.	Procedure or surgery	MRI Evaluation of Contralateral Breast

Primary outcome

MRI Diagnostic Yield of Cancers in the Contralateral Breast
Time frame: within 90 days of a negative mammogram of the study breast
To assess the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam. the "Test" status was defined based on combinations of the following 4 factors: 1. The initial BI-RADs: from the MRI of the contralateral breast 2. The final BI-RADs: determined after all subsequent work-up and follow-up within 365 from the initial MRI (an explicit recommendation for biopsy always resulted in a final BI-RADs of 4). 3. Subsequent work-up includes all procedures resultant from an Initial MRI finding (generally triggered by a BI-RADs 0 or 3) within 365 from the initial MRI 4. Whether or not biopsy procedure (Bx) were performed on the contralateral (Study) breast within 365 from the initial MRI

2 secondary outcomes

MRI Detection of Cancer in the Contralateral Breast for the Estimation of Diagnostic Accuracy
Time frame: within 90 days of a negative mammogram of the study breast
AUC as a Measure of the Accuracy of MRI for the Detection of Cancer in the Contralateral Breast
Time frame: within 90 days of a negative mammogram of the study breast

Results and safety

Results posted to the registry on 27 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MRI Evaluation of Contralateral Breast	1,007	969

Primary outcome: MRI Diagnostic Yield of Cancers in the Contralateral Breast

Time frame: within 90 days of a negative mammogram of the study breast. Count of participants. Unit: Participants

Measure	Reference Standard Positive (RS+) n = 33	Reference Standard Negative (RS-) n = 936
Test + (Final BI-RAD 0, 4, 5): Test Positive (T+)	30	114
Test + (Final BI-RAD 0, 4, 5): Test Negative (T-)	3	822
Test + (Initial MRI BI-RAD 4, 5/work-up): Test Positive (T+)	30	105
Test + (Initial MRI BI-RAD 4, 5/work-up): Test Negative (T-)	3	831
Test + (Initial MRI BI-RAD 4, 5/work-up/comp bx): Test Positive (T+)	30	91
Test + (Initial MRI BI-RAD 4, 5/work-up/comp bx): Test Negative (T-)	3	845
Test + (Initial MRI BI-RAD 0, 4, 5): Test Positive (T+)	30	143
Test + (Initial MRI BI-RAD 0, 4, 5): Test Negative (T-)	3	793

Reference Standard Positive (RS+): Binomial proportion: 0.031 (95% CI 0.020 to 0.042)
Reference Standard Positive (RS+): Binomial Proportion: 0.031 (95% CI 0.021 to 0.044)
Reference Standard Positive (RS+): Binomial Proportion: 0.031 (95% CI 0.020 to 0.042)

Population analysed: All eligible participants with an analyzable MRI

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 DAYS POST Intervention. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MRI Evaluation of Contralateral Breast	0 of 1,007 (0%)	0 of 1,007 (0%)	0 of 1,007

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22915431DeMartini WB, Hanna L, Gatsonis C, Mahoney MC, Lehman CD. Evaluation of tissue sampling methods used for MRI-detected contralateral breast lesions in the American College of Radiology Imaging Network 6667 trial. AJR Am J Roentgenol. 2012 Sep;199(3):W386-91. doi: 10.2214/AJR.11.7000.
Results publication: PubMed 20501712Weinstein SP, Hanna LG, Gatsonis C, Schnall MD, Rosen MA, Lehman CD. Frequency of malignancy seen in probably benign lesions at contrast-enhanced breast MR imaging: findings from ACRIN 6667. Radiology. 2010 Jun;255(3):731-7. doi: 10.1148/radiol.10081712.
Results publication: PubMed 17392300Lehman CD, Gatsonis C, Kuhl CK, Hendrick RE, Pisano ED, Hanna L, Peacock S, Smazal SF, Maki DD, Julian TB, DePeri ER, Bluemke DA, Schnall MD; ACRIN Trial 6667 Investigators Group. MRI evaluation of the contralateral breast in women with recently diagnosed breast cancer. N Engl J Med. 2007 Mar 29;356(13):1295-303. doi: 10.1056/NEJMoa065447. Epub 2007 Mar 28.
Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Constance Lehman, MD, PhD study chair

Seattle Cancer Care Alliance

21 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MRI in people with Breast Cancer and Contralateral Breast Cancer, run by American College of Radiology Imaging Network at 21 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 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Canada, Germany. 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?

Yes. Results are posted in the registry (first posted 27 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

MRI Diagnostic Yield of Cancers in the Contralateral Breast (time frame: within 90 days of a negative mammogram of the study breast). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00058058, 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 16 Jul 2019.