18F-FDG PET/CT Imaging for Breast Cancer
Primary Purpose
Breast Cancer Female, Breast Cancer Recurrent
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
18F-FDG PET/CT
Sponsored by

About this trial
This is an interventional diagnostic trial for Breast Cancer Female
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)
Sites / Locations
- Drammen Hospital - Vestre Viken HFRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Primary breast cancer
Recurrent breast cancer
Arm Description
Patients diagnosed with new breast cancer determined to have "high risk" disease by a multidisciplinary team.
Patients with suspected or proven locoregional recurrent breast cancer.
Outcomes
Primary Outcome Measures
Change in staging and/or management due to added 18F-FDG PET/CT scan
Percentage of the patients with change in staging and/or management
Secondary Outcome Measures
Overall survival
Survival after 18F-FDG PET/CT scan
Full Information
NCT ID
NCT05730608
First Posted
January 27, 2023
Last Updated
February 17, 2023
Sponsor
Vestre Viken Hospital Trust
1. Study Identification
Unique Protocol Identification Number
NCT05730608
Brief Title
18F-FDG PET/CT Imaging for Breast Cancer
Official Title
Improving Breast Cancer Staging With 18F-FDG PET/CT Imaging (The IMBRECAS PET Study)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2023 (Actual)
Primary Completion Date
December 31, 2032 (Anticipated)
Study Completion Date
December 31, 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vestre Viken Hospital Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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:
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Breast Cancer Recurrent
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Primary breast cancer
Arm Type
Other
Arm Description
Patients diagnosed with new breast cancer determined to have "high risk" disease by a multidisciplinary team.
Arm Title
Recurrent breast cancer
Arm Type
Other
Arm Description
Patients with suspected or proven locoregional recurrent breast cancer.
Intervention Type
Other
Intervention Name(s)
18F-FDG PET/CT
Intervention Description
Included breast cancer patients will undergo a 18F-FDG PET/CT scan in addition to conventional imaging with CT and bone scintigraphy.
Primary Outcome Measure Information:
Title
Change in staging and/or management due to added 18F-FDG PET/CT scan
Description
Percentage of the patients with change in staging and/or management
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Survival after 18F-FDG PET/CT scan
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harald Grut, MD, PHD
Phone
004797108503
Email
harald.grut@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harald Grut, MD, PHD
Organizational Affiliation
Vestre Viken Hospital Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drammen Hospital - Vestre Viken HF
City
Drammen
ZIP/Postal Code
N-3004
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harald Grut, MD, PHD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD available by request (Harald Grut, harald.grut@gmail.com)
IPD Sharing Time Frame
10.02.23 to 31.12.32
IPD Sharing Access Criteria
IPD available by request (Harald Grut, harald.grut@gmail.com)
Learn more about this trial
18F-FDG PET/CT Imaging for Breast Cancer
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