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

NCT06949215 | Not Yet Recruiting Phase 2

• 1 other identifier: NYCRCCL
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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) 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.

Conditions

ccRCC; Complex Renal Cyst

Keywords

PET/CT; complex renal cyst; 68Ga-NYM096

Outcome Measures

Primary Outcomes (2)

• Binary reading of renal lesions identified on 68Ga-NYM096 PET/CT

  Define lesion as PET positive or PET negative lesion. The kidney lesion is designated as positive if the SUVmax of kidney lesions is higher than that of liver (reference).

  From study completion to 1 month after completion

• Histological classification of operated renal lesions

  The histological classification of operated renal lesions will be determined according to WHO classification of tumors, Feb 2004.

  From study completion to 1 month after completion

Secondary Outcomes (14)

• SUVmax of renal lesions identified on 68Ga-NYM096 PET/CT

  From study completion to 1 month after completion

• Intensity of CAIX staining of operated renal lesions

  From study completion to 1 month after completion

• SUVmax of liver uptake on 68Ga-NY104 PET/CT

  From study completion to 1 month after completion

• Tumor grade of operated renal lesions

  From study completion to 1 month after completion

• Extent of CAIX staining of operated renal lesions

  From study completion to 1 month after completion

Study Arms (1)

68Ga-NYM096 PET/CT

EXPERIMENTAL

Each patient will receive one dose of 68Ga-NYM096 by intravenous route. Dedicated whole-body PET/CT imaging will be performed.

Diagnostic Test: 68Ga-NYM096 PET/CT

Interventions

68Ga-NYM096 PET/CT DIAGNOSTIC_TEST

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.

68Ga-NYM096 PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Central Study Contacts

Li Huo, MD

CONTACT

+86 18612672038; huoli@pumch.cn

Wenjia Zhu, MD

CONTACT

+86 18614080164; zhuwenjia_pumc@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: April 29, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 2 years after the publication of the main results