NCT01931709

Brief Summary

This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) in predicting response to treatment in patients with breast cancer. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 14, 2017

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2022

Completed
Last Updated

November 18, 2023

Status Verified

October 1, 2023

Enrollment Period

4.3 years

First QC Date

August 26, 2013

Results QC Date

March 24, 2017

Last Update Submit

October 25, 2023

Conditions

Male Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Favorable Pathologic Response at Surgery

    The primary clinical endpoint is dichotomous (yes/no) - Has patient achieved favorable microscopic pathologic response at surgery? This favorable pathologic response is defined as: 1. No evidence of microscopic invasive tumor at the primary tumor site and in regional axillary lymph nodes = Residual Cancer Burden class 0 (RCB 0) 2. Minimal invasive residual disease at primary tumor site and/or in regional axillary lymph nodes = Residual Cancer Burden class I (RCB I)

    At time of surgery

Secondary Outcomes (5)

  • Percent Change in PET K1 Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response

    Baseline to up to 12 weeks (mid-therapy)

  • Percent Change in Tumor Metabolism / Perfusion Ratio (MRFDG/K1) Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response

    Baseline to up to 12 weeks (mid-therapy)

  • Time From Surgery to Breast Cancer Recurrence

    The time from surgery to breast cancer recurrence. If recurrence does not occur during follow-up, the endpoint will be censored at the time of last documented disease-free status.

  • Time of Surgery to Overall Survival

    Overall survival from time of surgery. If death does not occur during follow-up, the endpoint will be censored at the date of last contact when the patient was verified as alive.

  • Percent Change in DCE-MRI Peak Percent Enhancement (Peak PE) Between Mid-therapy and Pre-therapy Breast MRI Scans and Its Association With Pathologic Response

    Baseline to up to 12 weeks (mid-therapy)

Study Arms (1)

Diagnostic (FDG PET and DCE-MRI)

EXPERIMENTAL

Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).

Radiation: fludeoxyglucose F 18Device: positron emission tomographyDevice: dynamic contrast-enhanced magnetic resonance imagingOther: laboratory biomarker analysis

Interventions

fludeoxyglucose F 18RADIATION

Undergo FDG PET

Also known as: 18FDG, FDG
Diagnostic (FDG PET and DCE-MRI)
positron emission tomographyDEVICE

Undergo FDG PET

Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Diagnostic (FDG PET and DCE-MRI)
dynamic contrast-enhanced magnetic resonance imagingDEVICE

Undergo DCE-MRI

Also known as: DCE-MRI
Diagnostic (FDG PET and DCE-MRI)
laboratory biomarker analysisOTHER

Correlative studies

Diagnostic (FDG PET and DCE-MRI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy
  • Primary tumor 2.0 cm or greater, and/or clinical evidence of axillary disease (palpable N1 or N2 or biopsy proven)
  • No obvious contraindications for primary chemotherapy
  • Able to lie still for PET and MRI scanning
  • Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines

You may not qualify if:

  • Serious systemic illness other than breast cancer
  • Contraindication to MRI or history of adverse reaction to gadolinium
  • Evidence of distant disease outside of regional lymph nodes
  • Pregnant
  • Poorly controlled diabetes mellitus (fasting blood glucose \> 200)
  • Prior systemic cancer therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • Kazerouni AS, Peterson LM, Jenkins I, Novakova-Jiresova A, Linden HM, Gralow JR, Hockenbery DM, Mankoff DA, Porter PL, Partridge SC, Specht JM. Multimodal prediction of neoadjuvant treatment outcome by serial FDG PET and MRI in women with locally advanced breast cancer. Breast Cancer Res. 2023 Nov 9;25(1):138. doi: 10.1186/s13058-023-01722-4.

    PMID: 37946201DERIVED

MeSH Terms

Conditions

Breast Neoplasms, MaleBreast Neoplasms

Interventions

Fluorodeoxyglucose F18Positron-Emission TomographyTomography, Emission-ComputedDynamic Contrast Enhanced Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydratesImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, RadioisotopeMagnetic Resonance Imaging

Results Point of Contact

Title
Jennifer Specht, MD
Organization
University of Washington
jspecht@uw.edu
206-288-6889

Study Officials

  • Jennifer Specht

    Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2013

First Posted

August 29, 2013

Study Start

November 1, 2011

Primary Completion

February 1, 2016

Study Completion

October 26, 2022

Last Updated

November 18, 2023

Results First Posted

June 14, 2017

Record last verified: 2023-10

Locations

US(1)