Clinical trial NCT01190566: PET-MR for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer
Official title: PET-MR Fusion Imaging and Surrogate Marker for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Magnetic Resonance Imaging, Functional
Tomography, Positron-Emission
chemotherapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2010-08-27
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients who are candidates for neoadjuvant chemotherapy, pre-treatment MRI and PET scan, post-treatment MRI and PET scan for evaluation of chemotherapy response monitoring and residual disease

Brief 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

Detailed description: Enrolled women with breast cancers who had received an anthracycline-taxane regimen and subsequent surgery were prospectively enrolled. DCE-MRI and FDG-PET scan were performed before and after the 1st cycle of chemotherapy. MR imaging parameters and SUV on PET scan within a tumor were analyzed. Clinicopathologic (age, clinical tumor stage, hormonal receptor status, and surgery type) and imaging parameters were compared according to the pathological response.

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

Primary outcomes:
measure: Patholocial Response to Chemotherapy
timeFrame: Post-operation
Secondary outcomes:
measure: Tumor Size
timeFrame: baseline, completion of 1st cycle of chemotherapy
measure: Tumor Volume
timeFrame: Baseline, post-1st chemotherapy
measure: Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)
timeFrame: Baseline, post-1st chemotherapy
measure: Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)
timeFrame: Baseline, post-1st chemotherapy
measure: Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep)
timeFrame: Baseline, post-1st chemotherapy
measure: Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)
timeFrame: Baseline, post-1st chemotherapy
measure: Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy
timeFrame: Baseline, post-1st chemotherapy
measure: Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography
timeFrame: Baseline, post-1st chemotherapy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of Radiology, Seoul National University Hospital
name: Woo Kyung Moon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho N, Im SA, Park IA, Lee KH, Li M, Han W, Noh DY, Moon WK. Breast cancer: early prediction of response to neoadjuvant chemotherapy using parametric response maps for MR imaging. Radiology. 2014 Aug;272(2):385-96. doi: 10.1148/radiol.14131332. Epub 2014 Apr 13.