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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 (PET ABC)

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ClinicalTrials.gov Identifier: NCT02751710
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : November 11, 2021
Sponsor:
Collaborator:
Cancer Care Ontario
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

Tracking Information
First Submitted Date  ICMJE April 15, 2016
First Posted Date  ICMJE April 26, 2016
Last Update Posted Date November 11, 2021
Actual Study Start Date  ICMJE December 6, 2016
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2016)
Proportion of patients upstaged to Stage IV disease [ Time Frame: Within 30 days from date of randomization ]
Proportion of patients upstaged to Stage IV disease as a result of the imaging study, between the groups
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2016)
  • Proportion of patients who receive multimodal therapy of curative intent [ Time Frame: Within 12 months from date of randomization ]
  • Number of additional tests, such as imaging and biopsy, resulting from findings of study imaging [ Time Frame: Within 12 months from date of randomization ]
  • Prognostic ability of PET SUV of the primary lesion on the pathological response rate to neo-adjuvant chemotherapy [ Time Frame: Within 12 months from date of randomization ]
  • Disease Free Survival [ Time Frame: From date of randomization to date of event, assessed up to 5 years ]
    Objectively defined local or distance recurrence or death
  • Overall Survival [ Time Frame: From date of randomization to date of event, assessed up to 5 years ]
    Defined by all-cause mortality
  • Incremental economic analysis comparing the costs and outcomes of the treatment arms [ Time Frame: Within 5 years from date of randomization ]
    Utility values will be collected using the EQ-5D Health Utility Questionnaire and converted to quality adjusted life years (QALYs) by considering Overall Survival. Direct medical resources (i.e. tests, complications, hospitalizations, clinic visits, emergency dept., etc.) will be obtained. Costs ($CAN2016) for each resource identified and utilized will be determined. Finally, an incremental cost-utility analysis will be calculated comparing the 2 randomized arms to generate an incremental cost per QALY outcome.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer
Official Title  ICMJE Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4)
  • Stage IIb Breast Cancer (T3N0)
Intervention  ICMJE Other: Whole-body FDG PET-CT alone
FDG PET-CT imaging
Study Arms  ICMJE
  • Experimental: Whole-body FDG PET-CT alone
    Intervention: Other: Whole-body FDG PET-CT alone
  • No Intervention: Conventional breast cancer staging
    Conventional breast cancer staging consisting of a bone scan and CT imaging with contrast of the chest / abdomen & pelvis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 21, 2016)
370
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women (or men) with histological evidence of breast cancer for whom potentially curative treatment is planned.
  • Based on clinical information (physical exam, imaging):

    1. Stage III breast cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4), or
    2. Stage IIb breast cancer (T3N0), Note: T2N1 is not eligible
  • Considered for combined modality therapy (surgical resection, chemotherapy, radiotherapy) of curative intent.

Exclusion Criteria:

  • Age < 18 years,
  • ECOG performance status > and = 3,
  • Prior systemic therapy (e.g. neo-adjuvant chemotherapy or hormonal therapy) for current breast cancer,
  • Previous staging investigations for current breast cancer,
  • Breast cancer with primary histological subtypes other than ductal or lobular (Note: Patients with mixed disease will be eligible for randomization),
  • Clinical suspicion of metastatic disease,
  • Relative contraindications to PET (e.g. uncontrolled diabetes (i.e. inability to decrease serum glucose below 10.2 mmol/L), claustrophobia, inability to be still for 30 minutes),
  • Inability to lie supine for imaging with PET-CT,
  • Inability to undergo CT because of known allergy to contrast,
  • History of another invasive malignancy within the previous two years (exception of non melanoma skin cancer) or a synchronous primary cancer, including a synchronous contralateral breast cancer (Note: Patients found to have a contralateral breast cancer on study imaging following randomization will remain in the study),
  • Known pregnancy or lactating female,
  • Inability to complete the study or required follow-up.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Donna McCarty 905-527-2299 ext 42605 mcccartyd@mcmaster.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02751710
Other Study ID Numbers  ICMJE OCOG-2016-PETABC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ontario Clinical Oncology Group (OCOG)
Study Sponsor  ICMJE Ontario Clinical Oncology Group (OCOG)
Collaborators  ICMJE Cancer Care Ontario
Investigators  ICMJE
Principal Investigator: Ian Dayes, MD Juravinski Hospital and Cancer Centre
Principal Investigator: Andrea Eisen, MD Sunnybrook Health Sciences Centre
Principal Investigator: Ralph George, MD St. Michael's Hospital, CIBC Breast Centre
Principal Investigator: Ur Metser, MD Princess Margaret Hospital, Canada
Study Director: Mark Levine, MD Ontario Clinical Oncology Group (OCOG)
PRS Account Ontario Clinical Oncology Group (OCOG)
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP