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

Peking University

Status: Not yet enrolling

Conditions: Breast Cancer; Von Hippel Lindau Disease; Small Cell Lung Cancer; Cholangiocarcinoma; Non Small Cell Lung Cancer; Ovarian Cancer; Hepatocellular Carcinoma (HCC); Endometrial Cancer; Urothelial Carcinoma (UC); Clear Cell Renal Cell Cancer (ccRCC); Head and Neck Cancer; Cervical Cancer; Pancreatic Cancer; Colorectal Cancer

Treatments: Diagnostic Test: 18F-T2 PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT07557225

FCAIX002

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

18F-T2 PET/CT

Experimental group

Description:

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.

Treatment:

Diagnostic Test: 18F-T2 PET/CT