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68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma | Clinical Trials | Clareo Health

RECRUITINGNA

68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma

Evaluation of Diagnostic Value of 68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma

NCT06519760•Peking University First Hospital

Summary

The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 68Ga-C1 in PET/CT imaging in clear cell renal cell carcinoma patients. It will also learn about the safety, tolerability and radiation dosimetry of 68Ga-C1. Researchers will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.

Detailed Description

Carbonic anhydrase IX (CAIX) is a transmembrane protein which is highly expressed in approximately 95% of clear cell renal cell carcinomas, and it is closely related to tumor progression, patients prognosis and treatment response. Here, we developed a CAIX specific small molecule probe 68Ga-C1, which has shown a good diagnostic accuracy in PET/CT imaging in our preclinical mouse model of clear cell renal cell carcinoma. This enables high-contrast imaging of clear cell renal carcinoma, providing a new imaging method for the precise diagnosis of clear cell renal carcinoma. In this clinical trail, we will compare the diagnostic value of 68Ga-C1 PET/CT and 18F-FDG PET/CT in Chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Signed written informed consent；
•2. Age ≥18；
•3. Patients with confirmed or suspected clear cell renal cell carcinoma;
•4. Expected survival ≥6 months.

Exclusion Criteria

•1. Renal mass is known to be a metastasis of another primary tumor;
•2. Have other malignancies that require treatment;
•3. Have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks;
•4. Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 mL/min/1.73 m²;
•5. Pregnant and lactating women or female patients plan to become pregnant within 6 months;
•6. Uncontrolled psychiatric disorders;
•7. Vulnerable population (e.g., being in detention) or have a serious non-malignant disease (e.g., infectious disease, autoimmune disease, or metabolic disease).

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

July 30, 2024

Primary Completion Date

June 30, 2026

Completion Date

December 31, 2026

Last Updated

November 7, 2024

Enrollment

200

ESTIMATED participants

Conditions

Carbonic Anhydrase IXPET-CTClear Cell Renal Cell Carcinoma

Interventions

68Ga-C1

DRUG

Contacts

Kan Gong

CONTACT

(86)-010-83572075 kan.gong@bjmu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

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