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

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ClinicalTrials.gov Identifier: NCT01190566
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : July 7, 2015
Last Update Posted : July 7, 2015
Sponsor:
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Woo Kyung Moon, Seoul National University Hospital

Study Description
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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


Condition or disease
Breast Cancer

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 Design
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Study Type : Observational
Actual Enrollment : 57 participants
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
Study Start Date : May 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Patholocial Response to Chemotherapy [ Time Frame: Post-operation ]
    Pathological complete response (pCR) or non-pCR


Secondary Outcome Measures :
  1. Tumor Size [ Time Frame: baseline, completion of 1st cycle of chemotherapy ]
    Maximal tumor diameter measured on magnetic resonance imaging

  2. Tumor Volume [ Time Frame: Baseline, post-1st chemotherapy ]
    Tumor volume measured on 3-dimensional magnetic resonance imaging

  3. 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.

  4. Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans) [ Time Frame: Baseline, post-1st chemotherapy ]
  5. 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 ]
  6. Extracellular Extravascular Space Per Unit Volume of Tissue (Ve) [ Time Frame: Baseline, post-1st chemotherapy ]
  7. 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.

  8. Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography [ Time Frame: Baseline, post-1st chemotherapy ]

Biospecimen Retention:   None Retained
Core biopsy specimens of breast cancer

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190566


Locations
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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
Investigators
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Principal Investigator: Woo Kyung Moon, M.D., Ph.D. Department of Radiology, Seoul National University Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Woo Kyung Moon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01190566    
Other Study ID Numbers: PET-MR Breast Cancer
First Posted: August 27, 2010    Key Record Dates
Results First Posted: July 7, 2015
Last Update Posted: July 7, 2015
Last Verified: June 2015
Keywords provided by Woo Kyung Moon, Seoul National University Hospital:
Magnetic Resonance Imaging, Functional
Tomography, Positron-Emission
chemotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases