Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474604
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2007-05-16
Brief Title:
Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
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 patients 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 ie 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 ie 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VU-VICC-IRB-051230 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA068485 |
| P30CA068485 | NIH | None | None |
| VU-VICC-BRE-0588 | None | None | None |