18F-T2 PET/CT Imaging for CAIX Positive Solid Tumors

May 12, 2026 updated by: Meng LIU, Peking University First Hospital

Evaluation of Diagnostic Value of 18F-T2 PET/ CT Imaging for Tumors Likely to Express High Levels of CAIX

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Peking University First Hospital
          • Phone Number: +86 010-83576401
          • Email: bdyyll@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-T2 PET/CT
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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]
Time Frame: 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).
24 hours after the injection of 18F-T2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 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.
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
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
Time Frame: 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.
From study completion to 1 month after completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Principal Investigator: Meng Liu, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCAIX002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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