Non-small cell lung cancer
Conditions
Brief summary
Determining essential input parameters for the calculation of an appropriate sample size for a future prospective diagnostic study, Number and location of metastatic lesions that are detected on the 68Ga-FAPI-46 PET (measure of interest) but not on the 18F-FDG PET in combination with brain MRI (current standard of care), Number and location of metastatic lesions detected on the 18F FDG PET in combination with brain MRI (current standard of care) but not on 68Ga-FAPI-46 PET (measure of interest)
Detailed description
Number of patients with brain metastases on brain MRI (standard of care) and on 68Ga-FAPI-46 PET (measure of interest), In patients with brain metastases: number of brain metastases on brain MRI (standard of care) and on 68Ga-FAPI-46 PET (measure of interest), Number of patients with at least one 68Ga-FAPI-positive, 18F-FDG-negative lesion for which an additional investigation is clinically necessary, Number of patients whose disease stage is upstaged based on 68Ga-FAPI-46 PET/CT findings compared to staging based on 18F-FDG PET/CT and brain MRI
Interventions
DRUG68Ga-FAPI-46
Sponsors
Academisch Ziekenhuis Maastricht
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determining essential input parameters for the calculation of an appropriate sample size for a future prospective diagnostic study, Number and location of metastatic lesions that are detected on the 68Ga-FAPI-46 PET (measure of interest) but not on the 18F-FDG PET in combination with brain MRI (current standard of care), Number and location of metastatic lesions detected on the 18F FDG PET in combination with brain MRI (current standard of care) but not on 68Ga-FAPI-46 PET (measure of interest) | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with brain metastases on brain MRI (standard of care) and on 68Ga-FAPI-46 PET (measure of interest), In patients with brain metastases: number of brain metastases on brain MRI (standard of care) and on 68Ga-FAPI-46 PET (measure of interest), Number of patients with at least one 68Ga-FAPI-positive, 18F-FDG-negative lesion for which an additional investigation is clinically necessary, Number of patients whose disease stage is upstaged based on 68Ga-FAPI-46 PET/CT findings compared to staging based on 18F-FDG PET/CT and brain MRI | — |
Outcome results
None listed