68Ga-NYM096 PET/ CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Complex Cystic Renal Leision


Condition: ccRCC, Complex Renal Cyst

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06949215

Sponsor: Peking Union Medical College Hospital

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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-NYM0
  2. 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.
  3. Intercurrent medical condition that renders the patient ineligible for surgery.
  4. Pregnancy or breastfeeding.
  5. Severe claustrophobia.

View trial on ClinicalTrials.gov