Fibroblast Activation Protein Inhibitor, Malignant Tumor, Positron Emission Tomography
Conditions
Keywords
Malignant Tumor, Positron Emission Tomography, Fibroblast Activation Protein Inhibitor
Brief summary
Adding targeted covalent radiopharmaceutical (TCR) moiety to fibroblast activation protein inhibitor (FAPI) can increase tumor uptake and tumor retention in pre-clinical studies. This study is an open-labeled single-arm phase II diagnostic clinical trial to explore the clinical value of 68Ga-TCR-FAPI PET/CT in suspected malignant tumor patients.
Detailed description
TCR-FAPI can covalently bind to FAP that increase tumor uptake and tumor retention in pre-clinical studies, which elevates the ability for cancer imaging and facilitates the targeted radionuclide therapy. This study is an open-labeled single-arm phase II diagnostic clinical trial to explore the clinical value of 68Ga-TCR-FAPI PET/CT in suspected malignant tumor patients. Quantitative features (i.e., SUVmax) will be calculated to evaluate the PET images. Alternative imaging modality, including but not limited to, Ultrasound, CT, MRI, and PET/CT with other radiotracers, might be applied according to clinical needs. For patients who took surgery after multiple examination, tumor tissue and histopathology will also be obtained. For patients who underwent other treatment, treatment response of each individual lesion will be observed.
Interventions
DIAGNOSTIC_TEST68Ga-TCR-FAPI PET/CT
A dose of 3.7 MBq/kg 68Ga-TCR-FAPI will be intravenously injected and PET examination will be carried out within the specified time.
Sponsors
Peking University
Peking University Cancer Hospital & Institute
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
68Ga-TCR-FAPI PET/CT was used for patients with suspected malignant tumors
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Suspected to have malignant tumors (supported by MRI and/or CT and/or tumor markers and/or pathology report), the tumor may be newly diagnosed or previously treated; * Meet the indications for PET examination, show a clear indication and no contraindications; * Have a performance status of score ≥ 80 on KPS scale or score 0-1 points on ECOG scale, a relatively good general situation; * No major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection; * Be ≥ 18 years of age; * Be willing and able to understand the research content and provide written informed consent/assent for the trial.
Exclusion criteria
* Have a history of imaging agent allergies; * Does not meet the PET-CT scan sedation requirements, or has contraindications for PET-CT examination; * Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy | 90 days | The sensitivity, specificity, and accuracy of 68Ga-TCR-FAPI PET/CT to detect tumor lesions were calculated to evaluate the diagnostic efficacy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor uptake | 90days | The standardized uptake value (SUV) of lesions were calculated. |
Countries
China
Contacts
Primary ContactShaoyan Liu, M.D.
Outcome results
None listed