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

June 11, 2015 updated by: Woo Kyung Moon, Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patholocial Response to Chemotherapy
Time Frame: Post-operation
Pathological complete response (pCR) or non-pCR
Post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Size
Time Frame: baseline, completion of 1st cycle of chemotherapy
Maximal tumor diameter measured on magnetic resonance imaging
baseline, completion of 1st cycle of chemotherapy
Tumor Volume
Time Frame: Baseline, post-1st chemotherapy
Tumor volume measured on 3-dimensional magnetic resonance imaging
Baseline, post-1st chemotherapy
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.
Baseline, post-1st chemotherapy
Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)
Time Frame: Baseline, post-1st chemotherapy
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
Baseline, post-1st chemotherapy
Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)
Time Frame: Baseline, post-1st chemotherapy
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.
Baseline, post-1st chemotherapy
Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography
Time Frame: Baseline, post-1st chemotherapy
Baseline, post-1st chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ministry of Health & Welfare, Korea

Investigators

  • Principal Investigator: Woo Kyung Moon, M.D., Ph.D., Department of Radiology, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

August 25, 2010

First Submitted That Met QC Criteria

August 26, 2010

First Posted (Estimate)

August 27, 2010

Study Record Updates

Last Update Posted (Estimate)

July 7, 2015

Last Update Submitted That Met QC Criteria

June 11, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PET-MR Breast Cancer

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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