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

NCT ID: NCT01190566

Last Updated: 2015-07-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-05-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health & Welfare, Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Woo Kyung Moon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Woo Kyung Moon, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Radiology, Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Cho N, Im SA, Park IA, Lee KH, Li M, Han W, Noh DY, Moon WK. Breast cancer: early prediction of response to neoadjuvant chemotherapy using parametric response maps for MR imaging. Radiology. 2014 Aug;272(2):385-96. doi: 10.1148/radiol.14131332. Epub 2014 Apr 13.

Reference Type DERIVED
PMID: 24738612 (View on PubMed)

Related Links

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http://bri.snuh.org/pub/_/singlecont/view.do

Homepage of Seoul National University Hospital Biomedical Research Institute

Other Identifiers

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PET-MR Breast Cancer

Identifier Type: -

Identifier Source: org_study_id

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