Newer Breast MRI Sequences for the Evaluation of Breast Cancer -FIESTA, Vibrant-DE and IDEAL: Feasibility Evaluation
This study is ongoing, but not recruiting participants.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00579800
First received: December 20, 2007
Last updated: January 31, 2013
Last verified: January 2013
| Tracking Information | |||||
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| First Received Date ICMJE | December 20, 2007 | ||||
| Last Updated Date | January 31, 2013 | ||||
| Start Date ICMJE | July 2007 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To evaluate the feasibility of three new pulse sequences for breast MRI using newly developed software; FIESTA, Vibrant DE and IDEAL [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
To quantitatively and qualitatively assess performance of the two breast pulse sequences, and compare these results with the same parameters on standard breast MRI sequences. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00579800 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To quantitatively and qualitatively assess performance of the three breast pulse sequences, and compare these results with the same parameters on standard breast MRI sequences. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Newer Breast MRI Sequences for the Evaluation of Breast Cancer -FIESTA, Vibrant-DE and IDEAL: Feasibility Evaluation | ||||
| Official Title ICMJE | Newer Breast MRI Sequences for the Evaluation of Breast Cancer -FIESTA, Vibrant-DE and IDEAL: Feasibility Evaluation | ||||
| Brief Summary | The purpose of this study is to evaluate new computer software on breast magnetic resonance imaging (MRI). The information from this study may help doctors and scientists develop better ways to find breast cancer, and may help future patents with cancer. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE | Procedure: new software sequences, FIESTA and Vibrant-DE and IDEAL
Conventional images will be taken using the standard sequences consisting of T2-weighted imaging and T1-weighted imaging before and after contrast; these will be used for the diagnostic examination. FIESTA will be performed on 50 patients, while Vibrant-DE and IDEAL will be performed on the other 50 patients. |
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| Study Arm (s) | Experimental: women undergoing routine breast MRI
Conventional images will be taken using the standard sequences consisting of T2-weighted imaging and T1-weighted imaging before and after contrast; these will be used for the diagnostic examination. FIESTA will be performed on 50 patients, while Vibrant-DE and IDEAL will be performed on the other 50 patients.
Intervention: Procedure: new software sequences, FIESTA and Vibrant-DE and IDEAL |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 76 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00579800 | ||||
| Other Study ID Numbers ICMJE | 07-091 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Memorial Sloan-Kettering Cancer Center | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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