Evaluation Using FAPI-PET Targeting Cancer-associated Fibroblasts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PET/CT ([F-18]FAPI-74).
- Who it may be relevant to
- Registry conditions: Neoplasms. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug PET/CT ([F-18]FAPI-74)
PET/CT using \[18F\] FAPI-74 injection
Primary outcome measures
- Comparison of the uptake on FAPI-PET with conventional imaging [Time frame: Within 2 hours after administration of [F-18]FAPI-74 injection]
- Comparison with pathological specimens [Time frame: Within one month after FAPI-PET]
- Time course of uptake on FAPI-PET [Time frame: Approximately 6 months after initial FAPI-PET]
Eligibility criteria
Inclusion criteria
Patients who meet any of the following conditions.
- Patients who have been diagnosed with malignant tumors or suspected of having malignant tumors and have CT or FDG-PET examination.
- Patients who have been diagnosed with malignant tumor and are scheduled to receive or have undergone anticancer treatment such as chemotherapy or radiation therapy.
- Patients suspected of recurrence by clinical findings or diagnostic imaging such as CT or FDG-PET after treatment of malignant tumor
Exclusion criteria
- Pregnant women or patients who may be pregnant
- Pediatric patients requiring sedation
- Those who are judged to be inappropriate as subjects.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Japan · 1 center
- Osaka University Hospital — Suita
Publications
- Naka S, Watabe T, Lindner T, Cardinale J, Kurimoto K, Moore M, Tatsumi M, Mori Y, Shimosegawa E, Valla F Jr, Kato H, Giesel FL. One-pot and one-step automated radio-synthesis of [18F]AlF-FAPI-74 using a multi purpose synthesizer: a proof-of-concept experiment. EJNMMI Radiopharm Chem. 2021 Aug 21;6(1):28. doi: 10.1186/s41181-021-00142-z. PMID 34420105
Identifiers
NCT: NCT05442151 · 21472