68Ga-NY104 PET/CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses

68Ga-NY104 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-NY104 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-NY104 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-NY104 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.

63 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 y
2. Presence of a renal mass
3. Scheduled for surgical resection of renal mass (partial or total nephrectomy, open, laparoscopic, or robot-assisted technique)
4. Expected survival of at least 3 months
5. ECOG ≤ 2
6. Written informed consent provided for participation in the trial
7. In the opinion of investigator, willing and able to comply with required study procedures.

Exclusion Criteria:

1. On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NY104. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required.
2. Intercurrent medical condition that renders the patient ineligible for surgery.
3. Pregnancy or breastfeeding.
4. Severe claustrophobia.