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Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer

NCT02751710 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 369

Last updated 2024-01-19

No results posted yet for this study

Summary

This trial is being conducted to determine the impact of whole body FDG PET-CT vs. conventional staging in the management of patients presenting with clinical Stage III breast cancer. Eligible consenting patients with ductal or mixed histology breast cancer will be randomized 1:1 to whole body FDG PET-CT or conventional staging. Eligible consenting patients with lobular only histology will be entered into a separate single arm prospective study and will undergo whole body FDG PET-CT, CT with contrast of the chest/abdomen \& pelvis and a bone scan.

Conditions

  • Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4)
  • Stage IIb Breast Cancer (T3N0)

Interventions

OTHER

Whole-body FDG PET-CT alone

FDG PET-CT imaging

Sponsors & Collaborators

  • Cancer Care Ontario

    collaborator OTHER

  • Ontario Clinical Oncology Group (OCOG)

    lead OTHER

Principal Investigators

  • Ian Dayes, MD · Juravinski Hospital and Cancer Centre

  • Andrea Eisen, MD · Sunnybrook Health Sciences Centre

  • Ralph George, MD · St. Michael's Hospital, CIBC Breast Centre

  • Ur Metser, MD · Princess Margaret Hospital, Canada

  • Mark Levine, MD · Ontario Clinical Oncology Group (OCOG)

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-06
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02751710 on ClinicalTrials.gov