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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-T2 PET/CT | Experimental | Participants with tumors likely to express high levels of CAIX will receive an intravenous injection of 18F-T2 followed by PET/CT imaging. The participants will also receive a whole-body 18F-FDG PET/CT scan within a one-week period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-T2 PET/CT | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Diagnostic Sensitivity and Specificity of 18F-T2 PET/CT in the Evaluation of CAIX Positive Solid Tumors | 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. | From study completion to 1 month after completion |
| Incidence of Adverse Events [Safety and Tolerability] | Safety of administration of 18F-T2, according to Common Terminology Criteria for Adverse Events (CTCAE v6.0). | 24 hours after the injection of 18F-T2 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Standardized Uptake Value [SUVmax] of Primary and Metastatic Lesions on 18F-T2 PET/CT vs. 18F-FDG PET/CT | Comparison of maximum standardized uptake value (SUVmax) of primary and metastatic lesions between 18F-T2 PET/CT and 18F-FDG PET/CT. | From study completion to 1 month after completion |
| Mean Standardized Uptake Value [SUVmean] of Primary and Metastatic Lesions on 18F-T2 PET/CT vs. 18F-FDG PET/CT |
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Inclusion Criteria:
All participants must meet the following criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keting Tong | Contact | +86 010-83575252 | 1910301229@pku.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Meng Liu | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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Comparison of mean standardized uptake value (SUVmean) of primary and metastatic lesions between 18F-T2 PET/CT and 18F-FDG PET/CT. |
| From study completion to 1 month after completion |
| Correlation between T2 Uptake and CAIX Pathological Expression | 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. | From study completion to 1 month after completion |
| Dosimetry of 18F-T2 | 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. | From study completion to 1 month after completion |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D002295 | Carcinoma, Transitional Cell |
| D015179 | Colorectal Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D010051 | Ovarian Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D018281 | Cholangiocarcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D001943 | Breast Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D016889 | Endometrial Neoplasms |
| D006623 | von Hippel-Lindau Disease |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010182 | Pancreatic Diseases |
| D020752 | Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D000798 | Angiomatosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000072661 | Ciliopathies |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
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