18F-T2 PET/CT Imaging for CAIX Positive Solid Tumors
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: 18F-T2 PET/CT.
- Who it may be relevant to
- Registry conditions: Clear Cell Renal Cell Cancer (ccRCC), Urothelial Carcinoma (UC), Colorectal Cancer, Cervical Cancer. Basic parameters: from 18 years · 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
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Diagnostic Value of 18F-T2 PET/ CT Imaging for Tumors Likely to Express High Levels of CAIX
Overview
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 test 18F-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.
Primary outcome measures
- The Diagnostic Sensitivity and Specificity of 18F-T2 PET/CT in the Evaluation of CAIX Positive Solid Tumors [Time frame: From study completion to 1 month after completion]
- Incidence of Adverse Events [Safety and Tolerability] [Time frame: 24 hours after the injection of 18F-T2]
Secondary outcome measures (4)
- Maximum Standardized Uptake Value [SUVmax] of Primary and Metastatic Lesions on 18F-T2 PET/CT vs. 18F-FDG PET/CT [Time frame: 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 [Time frame: From study completion to 1 month after completion]
- Correlation between T2 Uptake and CAIX Pathological Expression [Time frame: From study completion to 1 month after completion]
- Dosimetry of 18F-T2 [Time frame: From study completion to 1 month after completion]
Eligibility criteria
Inclusion criteria
All participants must meet the following criteria:
- Written and voluntarily given Informed Consent.
- Male or female ≥18 years of age at time of consent.
- Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
- 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:
- 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.
- Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study.
- Be a female who is pregnant or breastfeeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Peking University First Hospital — Beijing
Identifiers
NCT: NCT07557225 · FCAIX002