Solid tumors
Conditions
Brief summary
The primary endpoint is the evaluation of the detection rate of 68Ga-FAPI-46 PET/CT, defined as the proportion of 68Ga-FAPI-46 positive patients and the total number of recruited patients. A positive patient is defined as a patient with at least one 68Ga-FAPI-46 positive lesion. Primary tumor, lymph nodes and metastasis will be considered positive if specific concentration of radioligand in target tissue exceeds the unspecific concentration in adjacent tissues.
Detailed description
Proportion of 68Ga-FAPI-46 PET/CT-positive patients over the total number of patients undergoing 68Ga-FAPI-46 PET/CT for each tumor histology, Proportion of 68Ga-FAPI-46 PET/CT-positive patients over the total number of patients undergoing 68Ga-FAPI-46 PET/CT for each lesion site and proportion of 68Ga-FAPI-46 PET/CT-positive lesions over the total number of lesions for each lesion site;, 68Ga-FAPI-46 uptake in terms of SUV, Safety is defined as the number and percentage of patients undergoing grade 1 to 4 adverse events according to CTCAE version 5.0 until 30 days post 68Ga-FAPI-46 PET/CT.
Interventions
None listed
Sponsors
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the evaluation of the detection rate of 68Ga-FAPI-46 PET/CT, defined as the proportion of 68Ga-FAPI-46 positive patients and the total number of recruited patients. A positive patient is defined as a patient with at least one 68Ga-FAPI-46 positive lesion. Primary tumor, lymph nodes and metastasis will be considered positive if specific concentration of radioligand in target tissue exceeds the unspecific concentration in adjacent tissues. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of 68Ga-FAPI-46 PET/CT-positive patients over the total number of patients undergoing 68Ga-FAPI-46 PET/CT for each tumor histology, Proportion of 68Ga-FAPI-46 PET/CT-positive patients over the total number of patients undergoing 68Ga-FAPI-46 PET/CT for each lesion site and proportion of 68Ga-FAPI-46 PET/CT-positive lesions over the total number of lesions for each lesion site;, 68Ga-FAPI-46 uptake in terms of SUV, Safety is defined as the number and percentage of patients undergoing grade 1 to 4 adverse events according to CTCAE version 5.0 until 30 days post 68Ga-FAPI-46 PET/CT. | — |
Countries
Italy
Outcome results
None listed