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

NCT07101900 | Enrolling By Invitation Phase 2

• 1 other identifier: K8607
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Clear Cell Renal Cell Carcinoma

Keywords

NYM096; PET/CT; NYCRPS-II; ccRCC; CAIX

Outcome Measures

Primary Outcomes (2)

• 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

• 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). Time Frame: From study completion to 1 month after completion

  From study completion to 1 month after completion

Secondary Outcomes (12)

• 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-NYM096 PET/CT

  From study completion to 1 month after completion

• Tumor grade of operated renal lesions

  From study completion to 1 month after completion

• Binary reading of renal lesions identified on diagnostic CT

  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 years;
• Gender: No restriction;
• Renal mass (solitary or multiple) with a maximum diameter ≥1 cm, confirmed by conventional imaging (ultrasound, non-contrast CT, contrast-enhanced CT, or MRI);
• Scheduled for renal mass resection (partial or total nephrectomy, via open, laparoscopic, or robot-assisted techniques) within 1 month;
• Life Expectancy:
• At least 3 months, as assessed by a clinician;
• ECOG Performance Status: 0-2;
• Informed Consent: Provision of written informed consent;
• Compliance: Willing and able to adhere to study procedures.

You may not qualify if:

• 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).
• Pregnancy/Lactation:
• Pregnant (positive blood/urine HCG) or breastfeeding women;
• childbearing potential without effective contraception.
• Other Contraindications:
• Claustrophobia;
• Weight \>150 kg ;
• Alcohol allergy.
• Any condition deemed by the investigator to interfere with study results or increase participant risk.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

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: July 28, 2025
• First Posted: August 3, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-07

Data Sharing

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

Locations

CN (1)