Neoplasms
Conditions
Brief summary
PET / CT examination using \[18F\] FAPI-74 is performed on patients diagnosed with malignant tumor, and the pathological condition is determined by comparing with FDG-PET/CT examination of conventional diagnostic imaging.
Detailed description
Cancer stroma accounts for more than 90% of all tumors, and cancer-related fibroblasts (CAFs) play an important role in the growth and progression of cancer. FAP expressed in CAF has been found to be expressed in many cancers, and \[68Ga\] FAPI-04 and \[18F\] FAPI-74, which are PET diagnostic agents for FAP ligand FAPI, have been used all over the world. The purpose of this study is to perform PET / CT using \[18F\] FAPI-74 injection for patients diagnosed with malignant tumors, mainly pancreatic cancer and gastric cancer to evaluate the pathology in detail by comparing with the FDG-PET/CT.
Interventions
PET/CT using \[18F\] FAPI-74 injection
Sponsors
Tadashi Watabe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients who meet any of the following conditions. 1. Patients who have been diagnosed with malignant tumors or suspected of having malignant tumors and have CT or FDG-PET examination. 2. Patients who have been diagnosed with malignant tumor and are scheduled to receive or have undergone anticancer treatment such as chemotherapy or radiation therapy. 3. Patients suspected of recurrence by clinical findings or diagnostic imaging such as CT or FDG-PET after treatment of malignant tumor
Exclusion criteria
1. Pregnant women or patients who may be pregnant 2. Pediatric patients requiring sedation 3. Those who are judged to be inappropriate as subjects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the uptake on FAPI-PET with conventional imaging | Within 2 hours after administration of [F-18]FAPI-74 injection | Comparison of SUV (standardized uptake value) of primary site and metastatic lesions between FAPI-PET and FDG-PET |
| Comparison with pathological specimens | Within one month after FAPI-PET | Comparison of expression level (staining score) in FAP immunostaining and SUV in FAPI-PET (FAP staining is graded by scoring evaluation: high expression (3 points), moderate expression (2 points), mild expression (1 point), and no significant expression (0 point).) |
| Time course of uptake on FAPI-PET | Approximately 6 months after initial FAPI-PET | Time course of uptake on FAPI-PET before and after treatment compared with conventional imaging |
Countries
Japan
Contacts
Primary ContactTadashi Watabe, M.D., Ph.D.
Outcome results
None listed