Clinical trial · Interventional
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
NCT07101900CI-TRIAL-00093333enrolling by invitationPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-NYM096 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NYM096 PET/CT
- description
- Each patient will receive one dose of 68Ga-NYM096 by intravenous route. Dedicated whole-body PET/CT imaging will be performed.
- interventionNames
- Diagnostic Test: 68Ga-NYM096 PET/CT
Primary outcomes (2)
- measure
- Histological classification of operated renal lesions
- timeFrame
- From study completion to 1 month after completion
- description
- The histological classification of operated renal lesions will be determined according to WHO classification of tumors, Feb 2004.
- measure
- Binary reading of renal lesions identified on 68Ga-NYM096 PET/CT
- timeFrame
- From study completion to 1 month after completion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.