Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants
MRI Evaluation of Breast Tumor Growth and Treatment Response
4 other identifiers
interventional
209
1 country
1
Brief Summary
RATIONALE: Diagnostic procedures, such as MRI, may help diagnose breast cancer. It may also help doctors predict a patient's response to treatment. PURPOSE: This clinical trial is studying breast MRI in women with known or suspected breast cancer and in healthy participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Mar 2006
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 16, 2007
CompletedFirst Posted
Study publicly available on registry
May 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2023
CompletedNovember 27, 2023
November 1, 2023
17.2 years
May 16, 2007
November 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of advanced, quantitative, multi-parametric magnetic resonance imaging (MRI) methods for characterizing breast tumors to develop potential surrogate imaging markers for diagnosis and prediction of treatment response
Quantitative, multi-parametric MRI imaging methods include Dynamic Contrast MRI, Diffusion Weighted MRI, and Magnetic Resonance Spectroscopy. Patients will include healthy female volunteers and women diagnosed with breast cancer. Time frames begin at study entry (healthy volunteers) , pre-surgical and pre- and post-chemotherapy (breast cancer patients)
on-study date and at 6 months, up to 4 years
Secondary Outcomes (2)
Correlation of biochemical data obtained from magnetic resonance analysis with clinical, radiological, and pathological findings
at 6 months
Establishment of an imaging data bank
at 6 months
Study Arms (2)
Participants without breast cancer
ACTIVE COMPARATORParticipants with breast cancer
EXPERIMENTALInterventions
A scan will be performed.
A scan will be performed.
A scan will be performed.
Eligibility Criteria
You may qualify if:
- Women who satisfy the following conditions are the only subjects who will be eligible for this study:
- Normal volunteers
- Subjects with known or suspected breast disease
- Subjects must have signed an approved consent form.
- Subjects must be ≥ 18 years old.
- The protocol nurse will check with the patient that there is no h/o kidney disease
- Normal creatinine and estimated GFR\* within 30 days under the following circumstances
- Had abnormal creatinine in the last 60 days
- Are over 60 years of age
- Has received chemotherapy within the past 30 days
- Has diabetes, HIV, renal disease or hx of renal cancer
- \* GFR will be calculated using: http://www.kidney.org/professionals/kdoqi/gfr\_calculator.cfm
- Patients with an eGFR\>90ml/min reported within 30 days, and who have not had intervening chemotherapy or other treatment or condition that might deteriorate renal function, may receive any gadolinium agent.
You may not qualify if:
- Children will be excluded from this study.
- Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology "MRI Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for each pre-menopausal subject.)
- Subjects found to have any constitutionally present non-MR compatible ferromagnetic materials will be excluded from this study.
- Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study
- Subjects for whom an MRI is technically not feasible (e.g. breast volume, obesity)
- Subjects who have vascular access ports or other implanted devices rated as anything other than "Safe" or "Conditional 6"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
Related Publications (2)
Yankeelov TE, Lepage M, Chakravarthy A, Broome EE, Niermann KJ, Kelley MC, Meszoely I, Mayer IA, Herman CR, McManus K, Price RR, Gore JC. Integration of quantitative DCE-MRI and ADC mapping to monitor treatment response in human breast cancer: initial results. Magn Reson Imaging. 2007 Jan;25(1):1-13. doi: 10.1016/j.mri.2006.09.006. Epub 2006 Nov 21.
PMID: 17222711RESULTLi X, Abramson RG, Arlinghaus LR, Chakravarthy AB, Abramson V, Mayer I, Farley J, Delbeke D, Yankeelov TE. An algorithm for longitudinal registration of PET/CT images acquired during neoadjuvant chemotherapy in breast cancer: preliminary results. EJNMMI Res. 2012 Nov 16;2(1):62. doi: 10.1186/2191-219X-2-62.
PMID: 23157877DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
A. Bapsi Chakravarthy, MD
Vanderbilt-Ingram Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor; Radiation Oncology
Study Record Dates
First Submitted
May 16, 2007
First Posted
May 17, 2007
Study Start
March 1, 2006
Primary Completion
April 25, 2023
Study Completion
April 25, 2023
Last Updated
November 27, 2023
Record last verified: 2023-11