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

Peking University

Status: Enrolling

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

Treatments: Drug: 68Ga-C1

Study type: Interventional

Funder types: Other

Identifiers

NCT06519760

2024#07-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

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

68Ga-C1

Experimental group

Description:

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.

Treatment:

Drug: 68Ga-C1