Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07469202
PHASE4

CYTALUX Dose Extension Study

Sponsor: On Target Laboratories, LLC

View on ClinicalTrials.gov

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.

Official title: Prospective, Multi Center, Open Label Non Inferiority Trial Evaluating the Clinical Adequacy of Intraoperative Tumor Fluorescence With Cytalux™ (Pafolacianine) Across Two Preoperative Administration Windows in Adults Undergoing Surgery for Suspected Lung Cancer or Confirmed Ovarian Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2026-05-15

Completion Date

2026-11-30

Last Updated

2026-03-13

Healthy Volunteers

No

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