Clinical trial NCT06949215: 68Ga-NYM096 PET/ CT for the Detection of ccRCC in Presurgical Patients With Complex Cystic Renal Leision
Official title: 68Ga-NYM096 PET/ CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Complex Cystic Renal Leision
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: ccRCC
Complex Renal Cyst
Keywords: PET/CT
complex renal cyst
68Ga-NYM096
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, single-center, single-arm, diagnostic phase 2 study aimed at evaluating the sensitivity and specificity of 68Ga-NYM096 PET/CT in detecting clear cell renal cell carcinoma (ccRCC) in patients with complex renal cysts who are scheduled for surgical resection. The study will use histopathological diagnosis as the reference standard to assess the diagnostic accuracy of 68Ga-NYM096 PET/CT in identifying ccRCC within operable complex renal cystic lesion. The findings will provide critical insights into the performance of 68Ga-NYM096 PET/CT as a non-invasive imaging tool for the preoperative detection of ccRCC in this patient population.

Detailed description: This is a prospective, single-center, single-arm, diagnostic phase 2 study designed to evaluate the efficacy of 68Ga-NYM096 PET/CT in detecting clear cell renal carcinoma (ccRCC) in patients with complex renal cysts who are scheduled for surgical resection. Each patient will receive a single intravenous dose of 68Ga-NYM096, followed by dedicated whole-body PET/CT imaging. Prior to tumor resection, contrast-enhanced CT imaging of the abdomen will be conducted, and if clinically indicated or as part of the local standard of care, imaging of the chest will also be performed. Both imaging modalities (68Ga-NYM096 PET/CT and diagnostic CT) will be completed before kidney resection.

The PET/CT images will be independently interpreted by two blinded readers, while the diagnostic CT images will be evaluated by one blinded reader. The interpretations from both imaging modalities will be compared with histopathologic findings to estimate sensitivity, specificity, and predictive values (primary and secondary objectives). Additionally, the study will explore the performance of 68Ga-NYM096 PET/CT in detecting metastases compared to diagnostic CT. This study aims to provide insights into the diagnostic accuracy of 68Ga-NYM096 PET/CT for identifying ccRCC in patients with complex renal cysts.

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

39 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 y
2. Presence of complex renal cyst (Bosniak category II or higher)
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-NYM096 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NYM096. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NYM096 PET/CT is required.
2. Intercurrent medical condition that renders the patient ineligible for surgery.
3. Pregnancy or breastfeeding.
4. Severe claustrophobia.

Primary outcomes:
measure: Binary reading of renal lesions identified on 68Ga-NYM096 PET/CT
timeFrame: From study completion to 1 month after completion
measure: Histological classification of operated renal lesions
timeFrame: From study completion to 1 month after completion
Secondary outcomes:
measure: SUVmax of renal lesions identified on 68Ga-NYM096 PET/CT
timeFrame: From study completion to 1 month after completion
measure: Intensity of CAIX staining of operated renal lesions
timeFrame: From study completion to 1 month after completion
measure: SUVmax of liver uptake on 68Ga-NY104 PET/CT
timeFrame: From study completion to 1 month after completion
measure: Tumor grade of operated renal lesions
timeFrame: From study completion to 1 month after completion
measure: Extent of CAIX staining of operated renal lesions
timeFrame: From study completion to 1 month after completion
measure: Binary reading of renal lesions identified on diagnostic CT
timeFrame: From study completion to 1 month after completion
measure: Size of renal lesions identified on diagnostic CT
timeFrame: From study completion to 1 month after completion
measure: Bosniak category of lesion on diagnostic CT
timeFrame: From study completion to 1 month after completion
measure: Number of metastatic lesions identified on 68Ga-NYM096 PET/CT
timeFrame: From study completion to 1 month after completion
measure: Location of metastatic lesions identified on 68Ga-NYM096 PET/CT
timeFrame: From study completion to 1 month after completion
measure: Size of metastatic lesions identified on 68Ga-NYM096 PET/CT
timeFrame: From study completion to 1 month after completion
measure: Number of metastatic lesions identified on diagnostic CT
timeFrame: From study completion to 1 month after completion
measure: Location of metastatic lesions on diagnostic CT
timeFrame: From study completion to 1 month after completion
measure: Size of metastatic lesions on diagnostic CT
timeFrame: From study completion to 1 month after completion
Other outcomes:
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