Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2023-02-16
2032-12-31
Brief Summary
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Hypothesis The hypothesis is that 18F-FDG PET/CT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III or locoregional recurrent BC.
Objectives
Primary:
To evaluate if a 18F-FDG PET/CT scan in the initial work up of patients diagnosed with stage II/III or locoregional recurrent BC will lead to change in staging and/or treatment.
Secondary:
* Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET/CT scan compared with the patients with unchanged stage of disease following 18F-FDG PET/CT.
* Obtain size of the primary BC from CT/MRI scan and evaluate if these metrics are correlated to outcome.
* Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome.
* Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome.
* Blood and tumor samples for molecular characterisation:
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Primary breast cancer
Patients diagnosed with new breast cancer determined to have "high risk" disease by a multidisciplinary team.
18F-FDG PET/CT
Included breast cancer patients will undergo a 18F-FDG PET/CT scan in addition to conventional imaging with CT and bone scintigraphy.
Recurrent breast cancer
Patients with suspected or proven locoregional recurrent breast cancer.
18F-FDG PET/CT
Included breast cancer patients will undergo a 18F-FDG PET/CT scan in addition to conventional imaging with CT and bone scintigraphy.
Interventions
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18F-FDG PET/CT
Included breast cancer patients will undergo a 18F-FDG PET/CT scan in addition to conventional imaging with CT and bone scintigraphy.
Eligibility Criteria
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Inclusion Criteria
* Non pregnant women \> 18 years
* Not receiving active treatment of other cancer types.
* Eastern Cooperative Oncology Group (ECOG) status 0-2.
Exclusion Criteria
* Males
* Age under 18
* Patients receiving active treatment for other cancers
* Poor general conditipon (ECOG 3 or higher)
18 Years
FEMALE
No
Sponsors
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Vestre Viken Hospital Trust
OTHER
Responsible Party
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Principal Investigators
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Harald Grut, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Vestre Viken Hospital Trust
Locations
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Drammen Hospital - Vestre Viken HF
Drammen, , Norway
Countries
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Central Contacts
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Facility Contacts
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Harald Grut, MD, PHD
Role: primary
Other Identifiers
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495077
Identifier Type: -
Identifier Source: org_study_id
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