Breast Cancer, Cervical Cancer, Cholangiocarcinoma, Clear Cell Renal Cell Cancer (ccRCC), Colorectal Cancer, Endometrial Cancer, Head and Neck Cancer, Hepatocellular Carcinoma (HCC), Non Small Cell Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Small Cell Lung Cancer, Urothelial Carcinoma (UC), Von Hippel Lindau Disease
Conditions
Brief summary
The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 18F-T2 in PET/CT imaging in participants with solid tumors. It will also assess the safety, tolerability and radiation dosimetry of 18F-T2.
Interventions
DIAGNOSTIC_TEST18F-T2 PET/CT
18F-T2 is injected intravenously with a dose of 0.05-0.10 mCi/kg. The CT and PET imaging session will begin approximately 60 minutes after 18F-T2 administration.
Sponsors
Peking University First Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
All participants must meet the following criteria: 1. Written and voluntarily given Informed Consent. 2. Male or female ≥18 years of age at time of consent. 3. Have the capacity to understand the study and be willing and able to comply with all protocol requirements. 4. Participants with histologically confirmed or suspected tumors of the following types, but not limited to: Clear Cell Renal Cell Cancer; Urothelial Carcinoma; Colorectal Cancer; Cervical Cancer; Ovarian Cancer; Head and Neck Cancer; Hepatocellular Carcinoma; Cholangiocarcinoma; Non Small Cell Lung Cancer; Small Cell Lung Cancer; Breast Cancer; Pancreatic Cancer; Endometrial Cancer; Von Hippel Lindau Disease.
Exclusion criteria
Participants will be excluded from participation in the study if one or more of the following criteria are met: 1. Have any serious non-malignant disease (e.g., psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or with the safety or compliance of the participant, as judged by the Investigator. 2. Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study. 3. Be a female who is pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Diagnostic Sensitivity and Specificity of 18F-T2 PET/CT in the Evaluation of CAIX Positive Solid Tumors | From study completion to 1 month after completion | The diagnostic performance of 18F-T2 PET/CT and 18F-FDG PET/CT for staging will be evaluated and compared, using histopathological findings as the gold standard or, if not available, follow-up clinical and conventional imaging examinations (ultrasound, CT, or MRI) for at least 3 months as the reference standard. |
| Incidence of Adverse Events [Safety and Tolerability] | 24 hours after the injection of 18F-T2 | Safety of administration of 18F-T2, according to Common Terminology Criteria for Adverse Events (CTCAE v6.0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Standardized Uptake Value [SUVmax] of Primary and Metastatic Lesions on 18F-T2 PET/CT vs. 18F-FDG PET/CT | From study completion to 1 month after completion | Comparison of maximum standardized uptake value (SUVmax) of primary and metastatic lesions between 18F-T2 PET/CT and 18F-FDG PET/CT. |
| Mean Standardized Uptake Value [SUVmean] of Primary and Metastatic Lesions on 18F-T2 PET/CT vs. 18F-FDG PET/CT | From study completion to 1 month after completion | Comparison of mean standardized uptake value (SUVmean) of primary and metastatic lesions between 18F-T2 PET/CT and 18F-FDG PET/CT. |
| Correlation between T2 Uptake and CAIX Pathological Expression | From study completion to 1 month after completion | Evaluation of the correlation between uptake parameters derived from 18F-T2 PET/CT and CAIX expression level measured by immunohistochemistry (IHC) in tumor tissue samples. |
| Dosimetry of 18F-T2 | From study completion to 1 month after completion | Research on the dose distribution of 18F-T2 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software. |
Countries
China
Contacts
CONTACTKeting Tong
PRINCIPAL_INVESTIGATORMeng Liu
Peking University First Hospital
Outcome results
None listed