68Ga-NYM096 PET/ CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses

68Ga-NYM096 PET/CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses

This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients who have renal masses scheduled for surgical resection. The goal is to determine the sensitivity and specificity of 68Ga-NYM096 PET/CT in the detection of clear cell renal cell carcinoma using histopathological diagnosis as ground truth, in patients with operable renal masses.

This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients with renal masses scheduled for surgical resection. Each patient will receive one dose of 68Ga-NYM096 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Additionally, prior to resection of the tumor, contrast-enhanced CT imaging of the abdomen, and if clinically warranted, or as part of the local standard of care, of the chest, will be performed. Both imaging modalities will be performed prior to resection of the kidney(s). PET/CT studies will be interpreted by two readers and diagnostic CT will be interpreted by one reader, all of whom will provide independent and blinded interpretations. Imaging interpretations and histopathologic evaluation data will be used to estimate the sensitivity, specificity, and predictive value (primary and secondary objectives) of each modality. The exploration into the detection of metastases by 68Ga-NYM096 PET/CT in comparison to diagnostic CT will also be performed.

The pathologist will identify representative tumor tissue for the determination of histology, grading, and CAIX expression.

100 patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.

Inclusion Criteria :

1. Age: ≥18 years;

2. Gender: No restriction;

3. Renal mass (solitary or multiple) with a maximum diameter ≥1 cm, confirmed by conventional imaging (ultrasound, non-contrast CT, contrast-enhanced CT, or MRI);

4. Scheduled for renal mass resection (partial or total nephrectomy, via open, laparoscopic, or robot-assisted techniques) within 1 month;

5. Life Expectancy:

   • At least 3 months, as assessed by a clinician;
   • ECOG Performance Status: 0-2;

6. Informed Consent: Provision of written informed consent;

7. Compliance: Willing and able to adhere to study procedures.

Exclusion Criteria :

1. Surgical Contraindications:

   • High anesthesia risk (ASA class ≥IV);
   • Severe cardiopulmonary dysfunction (NYHA class III-IV or FEV1 <50%);
   • Active bleeding or coagulation disorders (INR >1.5, platelets <80×10⁹/L).

2. Pregnancy/Lactation:

   • Pregnant (positive blood/urine HCG) or breastfeeding women;
   • childbearing potential without effective contraception.

3. Other Contraindications:

   • Claustrophobia;
   • Weight >150 kg ;
   • Alcohol allergy.

4. Any condition deemed by the investigator to interfere with study results or increase participant risk.