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

Not Applicable

Recruiting

• Conditions: Carbonic Anhydrase IX; Clear Cell Renal Cell Carcinoma; PET-CT
• Interventions: Drug: 68Ga-C1

• Registration Number: NCT06519760
• Lead Sponsor: Peking University First Hospital

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.

Study Timeline

• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-21
• Study First Posted: 2024-07-25
• Study Start: 2024-07-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-C1	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.

Primary Outcome Measures

Name	Time	Method
The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of malignant tumors	1 year	Compare the number of lesions detected by 68Ga-C1 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard.
The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of clear cell renal cell carcinoma	1 year	Compare the standardized Uptake Value (SUV) of lesions on 68Ga-C1 and 18F-FDG PET/CT

Secondary Outcome Measures

Name	Time	Method
Quantitative evaluation of 68Ga-C1	1 year	Evaluation of quantitative parameters of 68Ga-C1, such as time-activity curve.
The dosimetry of 68Ga-C1	1 year	Research on the dose distribution of 68Ga-C1 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software
Correlation with pathological expression	1 year	Analyze CAIX expression at the imaging level in combination with CAIX expression in pathological specimens

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China