Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
N/A N=1,007 Diagnostic

Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer

Breast Cancer · Contralateral Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00058058 ↗
Enrolled (actual)
1,007
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: MRI Diagnostic Yield of Cancers in the Contralateral Breast — 30; 114; 3; 822 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
MRI (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
American College of Radiology Imaging Network
Primary completion
Aug 2006

Outcome Measures

OutcomeResultp-value
PRIMARY
MRI Diagnostic Yield of Cancers in the Contralateral Breast		 30; 114; 3; 822; 30; 105 —
SECONDARY
MRI Detection of Cancer in the Contralateral Breast for the Estimation of Diagnostic Accuracy		 30; 114; 3; 822 —
SECONDARY
AUC as a Measure of the Accuracy of MRI for the Detection of Cancer in the Contralateral Breast		 2; 565; 2; 256; 10; 92 —

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

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00058058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search