NCT06922903

Phase III Clinical Trial to Evaluate INR101 Injection for PET/CT Imaging in Patients With Prostate Cancer.

A Multicenter, Open-label, Prospective Phase III Clinical Trial to Evaluate the Diagnostic Efficacy and Safety of INR101 Injection for PET/CT Imaging in Detecting Preoperative Pelvic Lymph Node Metastasis in Patients With Prostate Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Yunhe Pharmaceutical (Tianjin) Co., Ltd · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, open-label, prospective Phase III clinical trial to evaluate INR101 injection for PET/CT imaging in patients with Prostate Cancer

Detailed description

This is a prospective, multicenter, open-label, single-arm, non-randomized Phase III clinical trial evaluating the diagnostic efficacy and safety of INR101 injection PET/CT imaging in detecting the presence of pelvic lymph node metastasis in participants who are scheduled to undergo radical prostatectomy and pelvic lymph node dissection. Participants enrolled in clinical trial will receive a single intravenous injection of INR101 injection at a dose of 7 mCi ± 15%, and PET/CT imaging will be performed 80 to 120 minutes after the injection. The PET/CT images of INR101 injection for each participant will be interpreted independently by two readers blinded to all participant information. When the conclusions of the two readers are inconsistent, a third reader will be added for an adjudication interpretation (the third reader will also be in a blinded during the interpretation process and shall not be aware of the conclusions of the first two readers).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	INR101	INR101

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-04-11
• Last updated: 2025-04-13

Locations

32 sites across 1 country: China