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Safety and Efficacy Trial of a Targeted PSMA Fluorescent Contrast Agent (DGPR1008) for Intraoperative Imaging of Prostate Cancer

NCT07024030 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-06-17

No results posted yet for this study

Summary

a single-arm, open-label, multi-center study to evaluate safety, tolerability, pharmacokinetics, and the effectiveness of near-infrared fluorescence imaging during surgery.

Conditions

  • Prostate Cancer Patients Undergoing Radical Prostatectomy

Interventions

DRUG

0.02mg/kg

Slowly infuse intravenously 24 hours before the scheduled surgery. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field.

DRUG

0.04mg/kg

Slowly infuse intravenously 24 hours before the scheduled surgery. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field.

Sponsors & Collaborators

  • Haitao Niu, MD

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-30
Primary Completion
2024-12-31
Completion
2025-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07024030 on ClinicalTrials.gov