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CYTALUX Dose Extension Study

NCT07469202 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-03-13

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether giving Cytalux™ (pafolacianine) injection several days before surgery works as well as giving it closer to the time of surgery for helping surgeons see lesions during an operation. This study is being done in adult patients undergoing surgery for malignant or non-malignant lung lesions or for confirmed ovarian cancer.

Conditions

Interventions

DRUG

CYTALUX (pafolacianine) injection

CYTALUX™ (PAFOLACIANINE) INJECTION: folate analog ligand conjugated with an indole cyanine green-like dye. Each subject will be administered a single intravenous dose (0.025 mg/kg) based on their assigned cohort before initiation of intraoperative NIR fluorescent imaging

Sponsors & Collaborators

  • On Target Laboratories, LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

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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 NCT07469202 on ClinicalTrials.gov