68Ga-NYM096 PET/ CT for the Detection of ccRCC in Presurgical Patients With Complex Cystic Renal Leision
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 68Ga-NYM096 PET/CT
Treatment groups
70 Participants
are divided into 1 treatment groupLocations
1Peking Union Medical College100730, Beijing China
Sponsors and collaborators
Peking Union Medical College Hospital
Lead sponsor
Source ClinicalTrials.gov