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| Name | Class |
|---|---|
| Cancer Care Ontario | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole-body FDG PET-CT alone | Experimental |
| |
| Conventional breast cancer staging | No Intervention | Conventional breast cancer staging consisting of a bone scan and CT imaging with contrast of the chest / abdomen & pelvis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole-body FDG PET-CT alone | Other | FDG PET-CT imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients upstaged to Stage IV disease | Proportion of patients upstaged to Stage IV disease as a result of the imaging study, between the groups | Within 30 days from date of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who receive multimodal therapy of curative intent | Within 12 months from date of randomization | |
| Number of additional tests, such as imaging and biopsy, resulting from findings of study imaging | Within 12 months from date of randomization |
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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):
Considered for combined modality therapy (surgical resection, chemotherapy, radiotherapy) of curative intent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Mark Levine, MD | Ontario Clinical Oncology Group (OCOG) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada | ||
| London Regional Cancer Program |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41772273 | Derived | Metser U, Dayes IS, Parpia S, Eisen AF, Hodgson N, Cil TD, George R, Blanchette P, Arnaout A, Chan A, Levine MN. Prospective study on 18F-FDG PET-CT for staging locally advanced invasive lobular breast carcinoma. Br J Cancer. 2026 May;134(10):1387-1392. doi: 10.1038/s41416-026-03362-9. Epub 2026 Mar 2. | |
| 40762843 | Derived |
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| Prognostic ability of PET SUV of the primary lesion on the pathological response rate to neo-adjuvant chemotherapy | Within 12 months from date of randomization |
| Disease Free Survival | Objectively defined local or distance recurrence or death | From date of randomization to date of event, assessed up to 5 years |
| Overall Survival | Defined by all-cause mortality | From date of randomization to date of event, assessed up to 5 years |
| Incremental economic analysis comparing the costs and outcomes of the treatment arms | 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. | Within 5 years from date of randomization |
| London |
| Ontario |
| N6A 4L6 |
| Canada |
| Ottawa Hospital Regional Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario | P7B 6V4 | Canada |
| Sunnybrook Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Metser U, Ali Mirshahvalad S, Dayes IS, Parpia S, Levine MN. 18F-FDG PET/CT of Oligometastatic Disease in Locally Advanced Breast Cancer: PETABC Trial Post Hoc Analysis. Radiology. 2025 Aug;316(2):e243788. doi: 10.1148/radiol.243788. |
| 37235845 | Derived | Dayes IS, Metser U, Hodgson N, Parpia S, Eisen AF, George R, Blanchette P, Cil TD, Arnaout A, Chan A, Levine MN. Impact of 18F-Labeled Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography Versus Conventional Staging in Patients With Locally Advanced Breast Cancer. J Clin Oncol. 2023 Aug 10;41(23):3909-3916. doi: 10.1200/JCO.23.00249. Epub 2023 May 26. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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