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

This study is currently recruiting participants.
Verified July 2011 by Seoul National University Hospital
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01190566
First received: August 25, 2010
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition
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:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Change in the maximum dimension of the tumor over time [ Time Frame: baseline, completion of 1st cycle of chemotherapy, and completion of 6th cycle of chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Imaging parameters including MRI volume, choline peak, ADC, volume transfer constant, and SUV [ Time Frame: baseline, completion of 1st cycle of chemotherapy, and completion of 6th cycle of chemotherapy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Core biopsy specimens of breast cancer


Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190566

Contacts
Contact: Woo Kyung Moon, M.D., Ph.D. 82-2-2072-3928 ext 2584 moonwk@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Seock-Ah Im, M.D., Ph.D.     82-2-2072-0850     moisa@snu.ac.kr    
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Woo Kyung Moon, M.D., Ph.D. Department of Radiology, Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Department of Radiology, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01190566     History of Changes
Other Study ID Numbers: PET-MR Breast Cancer
Study First Received: August 25, 2010
Last Updated: July 20, 2011
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013