Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-30 @ 5:09 AM
Study NCT ID:
NCT00474604
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2007-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Study Overview
Official Title:
MRI Evaluation of Breast Tumor Growth and Treatment Response
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
PURPOSE: This clinical trial is studying breast MRI in women with known or suspected breast cancer and in healthy participants.
Detailed Description:
OBJECTIVES:
* Develop and combine advanced, quantitative, multiparametric magnetic resonance imaging methods (i.e., dynamic contrast-enhanced MRI \[DCE-MRI\], diffusion-weighted MRI \[DW-MRI\], and magnetic resonance spectroscopy \[MRS\]) to characterize breast tumors in women with known or suspected breast cancer.
* Identify surrogate biomarkers that can guide diagnosis and treatment of breast cancer using these methods.
* Correlate biochemical information obtained from magnetic resonance analysis with clinical, radiologic, and pathologic findings in these patients.
* Establish an imaging data bank that includes information on DCE-MRI, DW-MRI, and MRS findings in these patients and in healthy participants.
OUTLINE: Quantitative, multi-parametric magnetic imaging methods will be employed for breast imaging for the following subjects:
* Group A: Healthy volunteers who undergo up to 3 breast MRIs over 6 weeks.
* Group B: Patients diagnosed with breast cancer who will: 1) undergo preoperative breast MRI followed by definitive surgery or 2) undergo MRI prior to initiating neoadjuvant chemotherapy, at 1-2 weeks after initiation of chemotherapy, and prior to definitive surgery.
Clinical information, including radiologic and pathologic data, on all patients is collected for inclusion in the imaging data bank.
After completion of the study, patients and healthy participants are followed periodically.
* Develop and combine advanced, quantitative, multiparametric magnetic resonance imaging methods (i.e., dynamic contrast-enhanced MRI \[DCE-MRI\], diffusion-weighted MRI \[DW-MRI\], and magnetic resonance spectroscopy \[MRS\]) to characterize breast tumors in women with known or suspected breast cancer.
* Identify surrogate biomarkers that can guide diagnosis and treatment of breast cancer using these methods.
* Correlate biochemical information obtained from magnetic resonance analysis with clinical, radiologic, and pathologic findings in these patients.
* Establish an imaging data bank that includes information on DCE-MRI, DW-MRI, and MRS findings in these patients and in healthy participants.
OUTLINE: Quantitative, multi-parametric magnetic imaging methods will be employed for breast imaging for the following subjects:
* Group A: Healthy volunteers who undergo up to 3 breast MRIs over 6 weeks.
* Group B: Patients diagnosed with breast cancer who will: 1) undergo preoperative breast MRI followed by definitive surgery or 2) undergo MRI prior to initiating neoadjuvant chemotherapy, at 1-2 weeks after initiation of chemotherapy, and prior to definitive surgery.
Clinical information, including radiologic and pathologic data, on all patients is collected for inclusion in the imaging data bank.
After completion of the study, patients and healthy participants are followed periodically.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA068485 | NIH | None | https://reporter.nih.gov/quic… | View |
| VU-VICC-BRE-0588 | None | None | View | |
| VU-VICC-IRB-051230 | None | None | View |