PET-MR for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01190566
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-08-26
• Study First Posted: 2010-08-27
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2013-12-30
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-11
• Last Update Submitted: 2015-06-11
• Results First Posted: 2015-07-07
• Last Update Posted: 2015-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patholocial Response to Chemotherapy	Post-operation	Pathological complete response (pCR) or non-pCR

Secondary Outcome Measures

Name	Time	Method
Tumor Size	baseline, completion of 1st cycle of chemotherapy	Maximal tumor diameter measured on magnetic resonance imaging
Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)	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.
Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep)	Baseline, post-1st chemotherapy
Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)	Baseline, post-1st chemotherapy
Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)	Baseline, post-1st chemotherapy
Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy	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.
Tumor Volume	Baseline, post-1st chemotherapy	Tumor volume measured on 3-dimensional magnetic resonance imaging
Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography	Baseline, post-1st chemotherapy

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of