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Trial record 1 of 1 for:    NCT02751710
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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 : December 26, 2017
Sponsor:
Collaborator:
Cancer Care Ontario
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

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.

Condition or disease Intervention/treatment
Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4) Stage IIb Breast Cancer (T3N0) Other: Whole-body FDG PET-CT alone

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer
Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Whole-body FDG PET-CT alone Other: Whole-body FDG PET-CT alone
FDG PET-CT imaging
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Proportion of patients who receive multimodal therapy of curative intent [ Time Frame: Within 12 months from date of randomization ]
  2. Number of additional tests, such as imaging and biopsy, resulting from findings of study imaging [ Time Frame: Within 12 months from date of randomization ]
  3. 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 ]
  4. 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

  5. Overall Survival [ Time Frame: From date of randomization to date of event, assessed up to 5 years ]
    Defined by all-cause mortality

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751710


Contacts
Contact: Marc L Filion, MSc 905-527-2299 ext 42611 filion@mcmaster.ca

Locations
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Juliet Woll, BHSc    905-387-9711    wollj@HHSC.CA   
Principal Investigator: Bindi Dhesy, MD         
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Becky Petrie    519-685-8618    rebecca.petrie@lhsc.on.ca   
Principal Investigator: Phillip Blanchette, MD         
Ottawa Hospital Regional Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Luisa Ianni    613-798-5555    luianni@toh.ca   
Principal Investigator: Angele Arnaout, MD         
Thunder Bay Regional Health Sciences Centre Recruiting
Thunder Bay, Ontario, Canada, P7B 6V4
Contact: Lisa Miedema, RN       miedemal@tbh.net   
Principal Investigator: Adrien Chan, MD         
Sunnybrook Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Debra Burns       debra.burns@sunnybrook.ca   
Principal Investigator: Andrea Eisen, MD         
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Rehab Chahin    416-946-4501    Rehab.Chahin@uhn.ca   
Principal Investigator: Tulin Cil, MD         
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Cancer Care Ontario
Investigators
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)

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT02751710     History of Changes
Other Study ID Numbers: OCOG-2016-PETABC
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action