NCT01190566

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

July 7, 2015

Completed
Last Updated

July 7, 2015

Status Verified

June 1, 2015

Enrollment Period

3 years

First QC Date

August 25, 2010

Results QC Date

December 30, 2013

Last Update Submit

June 11, 2015

Conditions

Breast Cancer

Keywords

Magnetic Resonance Imaging, FunctionalTomography, Positron-Emissionchemotherapy

Outcome Measures

Primary Outcomes (1)

  • Patholocial Response to Chemotherapy

    Pathological complete response (pCR) or non-pCR

    Post-operation

Secondary Outcomes (8)

  • Tumor Size

    baseline, completion of 1st cycle of chemotherapy

  • Tumor Volume

    Baseline, post-1st chemotherapy

  • Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)

    Baseline, post-1st chemotherapy

  • Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)

    Baseline, post-1st chemotherapy

  • Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep)

    Baseline, post-1st chemotherapy

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 24738612DERIVED

Related Links

Biospecimen

Retention: NONE RETAINED

Core biopsy specimens of breast cancer

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Woo Kyung Moon
Organization
Seoul National University Hospital
moonwk@snu.ac.kr
82-2-2072-2584

Study Officials

  • Woo Kyung Moon, M.D., Ph.D.

    Department of Radiology, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 25, 2010

First Posted

August 27, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 7, 2015

Results First Posted

July 7, 2015

Record last verified: 2015-06

Locations

KR(1)