Extent of Breast Cancer and the Role of Pre-Operative Sonography and MRI
NCT ID: NCT02587663
Last Updated: 2019-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
300 participants
INTERVENTIONAL
2005-11-20
2012-11-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis For Patients With Newly Diagnosed Breast Cancer
NCT03176979
MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer
NCT01805076
Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants
NCT00474604
Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery
NCT00033397
Evaluation of Patients With Breast Cancer Using DCE-MRI, MRS, and Proteomics
NCT00656604
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To determine how surgical treatment is influenced by the three imaging arms.
II. To compare three imaging arms in terms of accurately measuring the size of the index lesion and the number and location of tumor foci (using surgical pathology as gold standard).
SECONDARY OBJECTIVES:
I. In women with dense breasts: To retrospectively compare the accuracy of three imaging arms in measuring the size of the index lesion and the number and location of tumor foci (using surgical pathology as the gold standard).
II. To report the incidence of synchronous contralateral breast cancers detected by the three imaging arms.
OUTLINE: Patients are assigned to 1 of 3 treatment groups.
GROUP 1: Patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound.
GROUP 2: Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound.
GROUP 3: Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI.
All patients undergo standard of care breast conserving surgery, or mastectomy if the tests indicate a change in the surgical plan.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1 (standard of care)
Patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound.
Mammography
Undergo bilateral mammography
Therapeutic Conventional Surgery
Undergo breast conserving surgery
Ultrasonography
Undergo targeted breast ultrasound
Group 2 (bilateral whole-breast ultrasound)
Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound.
Mammography
Undergo bilateral mammography
Therapeutic Conventional Surgery
Undergo breast conserving surgery
Ultrasonography
Undergo bilateral whole-breast ultrasound
Ultrasonography
Undergo targeted breast ultrasound
Group 3 (bilateral breast contrast-enhanced MRI)
Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI.
Contrast-enhanced Magnetic Resonance Imaging
Undergo bilateral breast contrast enhanced MRI
Mammography
Undergo bilateral mammography
Therapeutic Conventional Surgery
Undergo breast conserving surgery
Ultrasonography
Undergo targeted breast ultrasound
Gadolinium
Contrast agent used in MRI
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Contrast-enhanced Magnetic Resonance Imaging
Undergo bilateral breast contrast enhanced MRI
Mammography
Undergo bilateral mammography
Therapeutic Conventional Surgery
Undergo breast conserving surgery
Ultrasonography
Undergo bilateral whole-breast ultrasound
Ultrasonography
Undergo targeted breast ultrasound
Gadolinium
Contrast agent used in MRI
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Pathologically proven invasive breast cancer or ductal carcinoma in situ (DCIS) originally identified clinically or mammographically and diagnosed by percutaneous core biopsy
* Eligible for breast conserving surgery followed by radiation therapy
Exclusion Criteria
* Women with clinical or mammographic findings where breast conserving surgery is not an option
* Women that clinically or mammographically have breast cancers that are fixed to skin
* Women receiving neoadjuvant chemotherapy prior to surgery
* Women having contraindications to contrast-enhanced (CE)-MRI examination (e.g., claustrophobia and allergy to gadolinium)
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Linda Hovanessian-Larsen
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2011-01365
Identifier Type: REGISTRY
Identifier Source: secondary_id
1B-05-5
Identifier Type: OTHER
Identifier Source: secondary_id
1B-05-5
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.