Clinical trial NCT06519760: 68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma
Official title: Evaluation of Diagnostic Value of 68Ga-C1 PET/ CT Imaging in Clear Cell Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carbonic Anhydrase IX
PET-CT
Clear Cell Renal Cell Carcinoma
Keywords: Carbonic Anhydrase IX
68Ga-C1
PET-CT
Clear Cell Renal Cell Carcinoma
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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).

Primary outcomes:
measure: The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of clear cell renal cell carcinoma
timeFrame: 1 year
measure: The diagnostic efficacy of 68Ga-C1 PET/CT in the evaluation of malignant tumors
timeFrame: 1 year
Secondary outcomes:
measure: The dosimetry of 68Ga-C1
timeFrame: 1 year
measure: Quantitative evaluation of 68Ga-C1
timeFrame: 1 year
measure: Correlation with pathological expression
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Kan Gong
role: PRINCIPAL_INVESTIGATOR
References: