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

NCT ID: NCT06519760

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-30
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Carbonic Anhydrase IX; PET-CT; Clear Cell Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-C1

Subjects with suspected or confirmed clear cell renal cell carcinoma will receive an intravenous injection of 68Ga-C1 followed by PET imaging. The subjects will also receive a whole-body 18F-FDG PET/CT scan within a one-week period.

Group Type: EXPERIMENTAL

68Ga-C1

Intervention Type: DRUG

68Ga-C1 is injected intravenously with a dose of 0.05-0.10 mCi/kg

Interventions

68Ga-C1

68Ga-C1 is injected intravenously with a dose of 0.05-0.10 mCi/kg

Intervention Type: DRUG

Other Intervention Names

CAIX specific PET imaging

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

GONG Kan

Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kan Gong

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kan Gong

Role: CONTACT

kan.gong@bjmu.edu.cn

(86)-010-83572075

Facility Contacts

Yanyan Yu

Role: primary

bdyyll@126.com

+86 1066119025

Other Identifiers

2024#07-17

Identifier Type: -

Identifier Source: org_study_id