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CYTALUX™for the Intraoperative Imaging of Prostate Cancer

NCT06434909 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-10-21

No results posted yet for this study

Summary

This study is being done to compare how much using Cytalux™ (pafolacianine) with NIR (Near InfraRed) fluorescent imaging improves the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.

The U.S. Food and Drug Administration (FDA) has approved the targeted imaging agent pafolacianine (Cytalux) for use in ovarian cancer (2021) and lung cancer surgery (2022.)

Conditions

Interventions

DRUG

Cytalux™ (pafolacianine) for fluorescent imaging

Cytalux™ (pafolacianine) injection: folate analog ligand conjugated with an indole cyanine green-like dye for real-time cancer margin status. This is used in conjunction with appropriate imaging system.

PROCEDURE

Image Guided Surgery

prostatectomy using appropriate imaging system

Sponsors & Collaborators

  • On Target Laboratories, LLC

    collaborator INDUSTRY

  • Indiana University

    lead OTHER

Principal Investigators

  • Clinton Bahler, MD · Indiana University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-19
Primary Completion
2025-07-24
Completion
2025-07-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT06434909 on ClinicalTrials.gov