Status:
NOT_YET_RECRUITING
68Ga-NYM096 PET/ CT for the Detection of ccRCC in Presurgical Patients With Complex Cystic Renal Leision
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
ccRCC
Complex Renal Cyst
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 comp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT06949215
Start Date
May 1 2025
End Date
July 1 2027
Last Update
April 29 2025
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