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NCT Number: NCT07557225

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

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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Key information

Conditions

Clear Cell Renal Cell Cancer (ccRCC) Abnormalities, Multiple Adenocarcinoma Adnexal Diseases Angiomatosis Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Transitional Cell Cardiovascular Diseases Cervical Cancer Cholangiocarcinoma Ciliopathies Colonic Diseases Colorectal Cancer Colorectal Neoplasms Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Hepatocellular Carcinoma (HCC) Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Neurocutaneous Syndromes Non Small Cell Lung Cancer Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Small Cell Lung Cancer Small Cell Lung Carcinoma Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma (UC) Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vascular Diseases Von Hippel Lindau Disease von Hippel-Lindau Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location status: Recruiting

Location contact

Peking University First Hospital

CONTACT

[email protected]

+86 010-83576401

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Keting Tong

CONTACT

[email protected]

+86 010-83575252

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 29, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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