Clinical trial · Interventional
Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants
MRI Evaluation of Breast Tumor Growth and Treatment Response
NCT00474604CI-TRIAL-00071697completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diffusion-weighted magnetic resonance imaging | Procedure | — | UNRESOLVED |
| dynamic contrast-enhanced magnetic resonance imaging | Procedure | — | UNRESOLVED |
| magnetic resonance spectroscopic imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Participants without breast cancer
- interventionNames
- Procedure: diffusion-weighted magnetic resonance imaging
- Procedure: dynamic contrast-enhanced magnetic resonance imaging
- Procedure: magnetic resonance spectroscopic imaging
- type
- EXPERIMENTAL
- label
- Participants with breast cancer
- interventionNames
- Procedure: diffusion-weighted magnetic resonance imaging
- Procedure: dynamic contrast-enhanced magnetic resonance imaging
- Procedure: magnetic resonance spectroscopic imaging
Primary outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 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. Exclusion Criteria: * 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"
References
Publications (2)
- RESULTYankeelov 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 17222711
- DERIVEDLi 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 23157877