PET-MR for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01190566|
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : July 7, 2015
Last Update Posted : July 7, 2015
The purpose of this study is:
To validate the efficacy of multiparametric MRI, FDG-PET, RGD-PET, and PET-MR fusion imaging in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients.
To identify the optimal combination parameters of MR spectroscopy, diffusion-weighted MRI, dynamic contrast-enhanced MRI, FDG-PET, and RGD-PET in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients.
To compare the performances of dynamic contrast-enhanced MRI using parametric response map analysis versus those of pharmacokinetic parameters (Ktrans, kep, or Ve) in the early prediction of pathological responsiveness to neoadjuvant chemotherapy in breast cancer patients
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||57 participants|
|Official Title:||PET-MR Fusion Imaging and Surrogate Marker for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer Patients|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
- Patholocial Response to Chemotherapy [ Time Frame: Post-operation ]Pathological complete response (pCR) or non-pCR
- Tumor Size [ Time Frame: baseline, completion of 1st cycle of chemotherapy ]Maximal tumor diameter measured on magnetic resonance imaging
- Tumor Volume [ Time Frame: Baseline, post-1st chemotherapy ]Tumor volume measured on 3-dimensional magnetic resonance imaging
- Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI) [ Time Frame: Baseline, post-1st chemotherapy ]Parametric response map analysis using a software calculates the interval change of signal intensity based on a voxel-to-voxel comparison between measurements at baseline and after the first cycle of chemotherapy. PRMSI+ indicates proportions of voxels within a tumor with increased signal intensity. PRMSI- indicates proportions of voxels within a tumor with decreased signal intensity. PRMSI0 indicates proportions of voxels within a tumor with unchanged signal intensity.
- Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans) [ Time Frame: Baseline, post-1st chemotherapy ]
- Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep) [ Time Frame: Baseline, post-1st chemotherapy ]
- Extracellular Extravascular Space Per Unit Volume of Tissue (Ve) [ Time Frame: Baseline, post-1st chemotherapy ]
- Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy [ Time Frame: Baseline, post-1st chemotherapy ]Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation.
- Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography [ Time Frame: Baseline, post-1st chemotherapy ]
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190566
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Woo Kyung Moon, M.D., Ph.D.||Department of Radiology, Seoul National University Hospital|