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Trial Title:
18F-FDG PET/CT Imaging for Breast Cancer
NCT ID:
NCT05730608
Condition:
Breast Cancer Female
Breast Cancer Recurrent
Conditions: Official terms:
Breast Neoplasms
Fluorodeoxyglucose F18
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
18F-FDG PET/CT
Description:
Included breast cancer patients will undergo a 18F-FDG PET/CT scan in addition to
conventional imaging with CT and bone scintigraphy.
Arm group label:
Primary breast cancer
Arm group label:
Recurrent breast cancer
Summary:
Purpose To investigate the ability of 18F-FDG PET/CT imaging to detect metastases not
detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with
stage II/III and locoregional recurrent breast cancer (BC) which can affect the choice of
treatment.
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:
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with high risk primary or recurrent breast cancer
- Non pregnant women > 18 years
- Not receiving active treatment of other cancer types.
- Eastern Cooperative Oncology Group (ECOG) status 0-2.
Exclusion Criteria:
- Pregnant woman
- Males
- Age under 18
- Patients receiving active treatment for other cancers
- Poor general conditipon (ECOG 3 or higher)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Drammen Hospital - Vestre Viken HF
Address:
City:
Drammen
Zip:
N-3004
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Harald Grut, MD, PHD
Start date:
February 16, 2023
Completion date:
December 31, 2032
Lead sponsor:
Agency:
Vestre Viken Hospital Trust
Agency class:
Other
Source:
Vestre Viken Hospital Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05730608
