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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Seoul National University Hospital.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014