Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05730608
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-01-27
Brief Title:
18F-FDG PETCT Imaging for Breast Cancer
Sponsor:
Vestre Viken Hospital Trust
Organization:
Vestre Viken Hospital Trust
Study Overview
Official Title:
Improving Breast Cancer Staging With 18F-FDG PETCT Imaging The IMBRECAS PET Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose To investigate the ability of 18F-FDG PETCT imaging to detect metastases not detected by conventional imaging CT and bone scintigraphy in patients diagnosed with stage IIIII and locoregional recurrent breast cancer BC which can affect the choice of treatment
Hypothesis The hypothesis is that 18F-FDG PETCT can provide information about disease stage beyond the currently used conventional imaging CT and bone scintigraphy in patients diagnosed with stage IIIII or locoregional recurrent BC
Objectives
Primary
To evaluate if a 18F-FDG PETCT scan in the initial work up of patients diagnosed with stage IIIII or locoregional recurrent BC will lead to change in staging andor treatment
Secondary
Overall survival OS and progression-free survival PFS in the patients with upstaging based on findings on 18F-FDG PETCT scan compared with the patients with unchanged stage of disease following 18F-FDG PETCT
Obtain size of the primary BC from CTMRI 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
Hypothesis The hypothesis is that 18F-FDG PETCT can provide information about disease stage beyond the currently used conventional imaging CT and bone scintigraphy in patients diagnosed with stage IIIII or locoregional recurrent BC
Objectives
Primary
To evaluate if a 18F-FDG PETCT scan in the initial work up of patients diagnosed with stage IIIII or locoregional recurrent BC will lead to change in staging andor treatment
Secondary
Overall survival OS and progression-free survival PFS in the patients with upstaging based on findings on 18F-FDG PETCT scan compared with the patients with unchanged stage of disease following 18F-FDG PETCT
Obtain size of the primary BC from CTMRI 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None