68Ga-NYM096 PET/ CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses
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: Clear Cell Renal Cell Carcinoma. 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 Renal Masses
Overview
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.
Detailed description
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.
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
- Histological classification of operated renal lesions [Time frame: From study completion to 1 month after completion]
- Binary reading of renal lesions identified on 68Ga-NYM096 PET/CT [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-NYM096 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]
- 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]
- 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]
- Location of metastatic lesions on diagnostic CT [Time frame: From study completion to 1 month after completion]
- Size of metastatic lesions on diagnostic CT [Time frame: From study completion to 1 month after completion]
Eligibility criteria
Inclusion criteria
- Age: ≥18 years;
- Gender: No restriction;
- Renal mass (solitary or multiple) with a maximum diameter ≥1 cm, confirmed by conventional imaging (ultrasound, non-contrast CT, contrast-enhanced CT, or MRI);
- Scheduled for renal mass resection (partial or total nephrectomy, via open, laparoscopic, or robot-assisted techniques) within 1 month;
- Life Expectancy:
- At least 3 months, as assessed by a clinician;
- ECOG Performance Status: 0-2;
- Informed Consent: Provision of written informed consent;
- Compliance: Willing and able to adhere to study procedures.
Exclusion criteria
- 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).
- Pregnancy/Lactation:
- Pregnant (positive blood/urine HCG) or breastfeeding women;
- childbearing potential without effective contraception.
- Other Contraindications:
- Claustrophobia;
- Weight >150 kg ;
- Alcohol allergy.
- Any condition deemed by the investigator to interfere with study results or increase participant risk.
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 Hospital — Beijing
Identifiers
NCT: NCT07101900 · K8607