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

Breast Cancer Clinical Trial

Official title:

PET-MR Fusion Imaging and Surrogate Marker for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190566
• Other study ID #: PET-MR Breast Cancer
• Status: Completed
• Phase: N/A
• First received: August 25, 2010
• Last updated: June 11, 2015
• Start date: May 2010
• Est. completion date: May 2013

Study information

• Verified date: June 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patholocial Response to Chemotherapy	Pathological complete response (pCR) or non-pCR	Post-operation	No
Secondary	Tumor Size	Maximal tumor diameter measured on magnetic resonance imaging	baseline, completion of 1st cycle of chemotherapy	No
Secondary	Tumor Volume	Tumor volume measured on 3-dimensional magnetic resonance imaging	Baseline, post-1st chemotherapy	No
Secondary	Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)	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.	Baseline, post-1st chemotherapy	No
Secondary	Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)		Baseline, post-1st chemotherapy	No
Secondary	Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep)		Baseline, post-1st chemotherapy	No
Secondary	Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)		Baseline, post-1st chemotherapy	No
Secondary	Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy	Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation.	Baseline, post-1st chemotherapy	No
Secondary	Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography		Baseline, post-1st chemotherapy	No

External Links

•   Homepage of Seoul National University Hospital Biomedical Research Institute