None listed
Conditions
Interventions
Drug : This is a single-arm clinical trial, and all participants will receive the same intervention. Participants who meet the eligibility criteria and provide informed consent will undergo F-18 FAPI-
Sponsors
Korea Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are suspected of having recurrent sarcoma based on imaging studies or clinical findings during follow-up after primary treatment for sarcoma. 2. Patients who, before enrollment in the clinical trial, have received sufficient explanation from the study personnel regarding the purpose and content of the trial and the characteristics of the investigational product, and who have signed the informed consent form themselves or whose guardian or legally authorized representative has signed the informed consent form. 3. Patients aged 19 years or older. 4. Patients with an Eastern Cooperative Oncology Group Performance Status of 2 or less. 5. Patients who are expected to survive for at least 12 months. 6. Patients who meet the following laboratory criteria for hematologic, renal, and hepatic function: * Absolute neutrophil count = 1,500/µL * Platelet count > 100,000/µL * Blood urea nitrogen and serum creatinine < 2 × upper limit of normal * Aspartate aminotransferase and alanine aminotransferase < 5 × upper limit of normal
Exclusion criteria
Exclusion criteria: 1. Patients who are judged by the investigator to have a serious medical condition that makes participation in the clinical trial difficult. 2. Patients who are judged by the investigator to have a psychiatric condition that makes positron emission tomography imaging difficult. 3. Premenopausal women who are pregnant or breastfeeding at screening, or who plan to become pregnant during the study period. 4. Patients who are participating in another clinical trial at screening, if participation in that trial may affect the acquisition of Fluorine-18 fibroblast activation protein inhibitor positron emission tomography images or Fluorine-18 fluorodeoxyglucose positron emission tomography images. However, patients may participate in this study if they are enrolled in another observational cohort study that only involves follow-up and does not involve administration of an investigational product at screening. 5. Patients with inadequately controlled diabetes mellitus that may affect Fluorine-18 fluorodeoxyglucose positron emission tomography image acquisition. 6. Patients who are otherwise judged by the investigator to be unsuitable for participation in this clinical trial. 7. Vulnerable subjects, including the investigators participating in the study themselves or their family members, research staff or students of the investigators participating in the study, and family members of the subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of visual analysis of Fluorine-18 fibroblast activation protein inhibitor-74 positron emission tomography for the diagnosis of recurrent sarcoma | — |
Countries
Korea, Republic of
Contacts
Public ContactByeong hyeon Byeon
Korea Cancer Center Hospital
Outcome results
None listed