N/A
Completed N=48
PET-MR for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer
Source: ClinicalTrials.gov NCT01190566 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: Patholocial Response to Chemotherapy — 6; 42 participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patholocial Response to Chemotherapy |
6; 42 | — |
| SECONDARY Tumor Size |
4.9; 5.0; 4.2; 4.5 | — |
| SECONDARY Tumor Volume |
22.0; 38.9; 11.0; 26.4 | — |
| SECONDARY Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI) |
14.0; 40.7; 83.4; 56.4; 2.7; 2.9 | — |
| SECONDARY Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans) |
0.263; 0.254; 0.224; 0.234 | — |
| SECONDARY Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep) |
0.616; 0.787; 0.992; 0.616 | — |
| SECONDARY Extracellular Extravascular Space Per Unit Volume of Tissue (Ve) |
0.563; 0.550; 0.467; 0.557 | — |
| SECONDARY Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy |
15.0; 13.5; 3.4; 7.8 | — |
| SECONDARY Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography |
18.9; 10.7; 9.7; 7.6 | — |
Eligibility Criteria
Inclusion Criteria
- Pathologically confirmed breast cancer
- Clinical stage IIb, IIIa, IIIb, IIIc
- Must have measurable disease
- Performance status of ECOG 0-2
- Adequate, bone marrow, liver, heart, and renal function
- Who did not receive chemotherapy for breast cancer
- Must agree with and signed informed consent
Exclusion Criteria
- Prior history of cancer besides breast cancer
- Active bacterial infection
- Pregnant or lactating women
- Psychological disease or seizure
- History of arrhythmia, congestive heart failure, myocardial infarct, or unstable angina
- Male breast cancer
- Who had a pacemaker or history of open heart surgery
Data sourced from ClinicalTrials.gov (NCT01190566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.