68Ga-NYM096 PET/ CT for the Detection of ccRCC in Presurgical Patients With Complex Cystic Renal Leision
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-NYM096 PET/CT.
- Who it may be relevant to
- Registry conditions: ccRCC, Complex Renal Cyst. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
68Ga-NYM096 PET/ CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Complex Cystic Renal Leision
Overview
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.
Interventions
- Diagnostic test 68Ga-NYM096 PET/CT
Participants will be administered a single, intravenous bolus of 68Ga-NYM096 The recommended administered activity of 68Ga-NYM096 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ga / 68Ga generator. The CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NYM096 administration.
Primary outcome measures
- Binary reading of renal lesions identified on 68Ga-NYM096 PET/CT [Time frame: From study completion to 1 month after completion]
- Histological classification of operated renal lesions [Time frame: From study completion to 1 month after completion]
Secondary outcome measures (12)
- SUVmax of renal lesions identified on 68Ga-NYM096 PET/CT [Time frame: From study completion to 1 month after completion]
- Intensity of CAIX staining of operated renal lesions [Time frame: From study completion to 1 month after completion]
- SUVmax of liver uptake on 68Ga-NY104 PET/CT [Time frame: From study completion to 1 month after completion]
- Tumor grade of operated renal lesions [Time frame: From study completion to 1 month after completion]
- Extent of CAIX staining of operated renal lesions [Time frame: From study completion to 1 month after completion]
- Binary reading of renal lesions identified on diagnostic CT [Time frame: From study completion to 1 month after completion]
- Size of renal lesions identified on diagnostic CT [Time frame: From study completion to 1 month after completion]
- Bosniak category of lesion on diagnostic CT [Time frame: From study completion to 1 month after completion]
- Number of metastatic lesions identified on 68Ga-NYM096 PET/CT [Time frame: From study completion to 1 month after completion]
- Location of metastatic lesions identified on 68Ga-NYM096 PET/CT [Time frame: From study completion to 1 month after completion]
- Size of metastatic lesions identified on 68Ga-NYM096 PET/CT [Time frame: From study completion to 1 month after completion]
- Number of metastatic lesions identified on diagnostic CT [Time frame: From study completion to 1 month after completion]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 y
- Presence of complex renal cyst (Bosniak category II or higher)
- Scheduled for surgical resection of renal mass (partial or total nephrectomy, open, laparoscopic, or robot-assisted technique)
- Expected survival of at least 3 months
- ECOG ≤ 2
- Written informed consent provided for participation in the trial
- In the opinion of investigator, willing and able to comply with required study procedures.
Exclusion criteria
- 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.
- Intercurrent medical condition that renders the patient ineligible for surgery.
- Pregnancy or breastfeeding.
- Severe claustrophobia.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Peking Union Medical College — Beijing
Identifiers
NCT: NCT06949215 · NYCRCCL