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

This study has been completed.
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Woo Kyung Moon, Seoul National University Hospital Identifier:
First received: August 25, 2010
Last updated: June 11, 2015
Last verified: June 2015

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

Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PET-MR Fusion Imaging and Surrogate Marker for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer Patients

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Patholocial Response to Chemotherapy [ Time Frame: Post-operation ] [ Designated as safety issue: No ]
    Pathological complete response (pCR) or non-pCR

Secondary Outcome Measures:
  • Tumor Size [ Time Frame: baseline, completion of 1st cycle of chemotherapy ] [ Designated as safety issue: No ]
    Maximal tumor diameter measured on magnetic resonance imaging

  • Tumor Volume [ Time Frame: Baseline, post-1st chemotherapy ] [ Designated as safety issue: No ]
    Tumor volume measured on 3-dimensional magnetic resonance imaging

  • Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI) [ Time Frame: Baseline, post-1st chemotherapy ] [ Designated as safety issue: No ]
    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.

  • Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans) [ Time Frame: Baseline, post-1st chemotherapy ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Extracellular Extravascular Space Per Unit Volume of Tissue (Ve) [ Time Frame: Baseline, post-1st chemotherapy ] [ Designated as safety issue: No ]
  • Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy [ Time Frame: Baseline, post-1st chemotherapy ] [ Designated as safety issue: No ]
    Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation.

  • Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography [ Time Frame: Baseline, post-1st chemotherapy ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained
Core biopsy specimens of breast cancer

Enrollment: 57
Study Start Date: May 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01190566

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Health & Welfare, Korea
Principal Investigator: Woo Kyung Moon, M.D., Ph.D. Department of Radiology, Seoul National University Hospital
  More Information

Additional Information:
No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Woo Kyung Moon, Professor, Seoul National University Hospital Identifier: NCT01190566     History of Changes
Other Study ID Numbers: PET-MR Breast Cancer
Study First Received: August 25, 2010
Results First Received: December 30, 2013
Last Updated: June 11, 2015
Health Authority: Korea: Ministry for Health and Welfare

Keywords provided by Seoul National University Hospital:
Magnetic Resonance Imaging, Functional
Tomography, Positron-Emission

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases processed this record on November 24, 2015