CYTALUX Dose Extension Study

Sponsor
On Target Laboratories, LLC
Study ID
NCT07469202
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CYTALUX (pafolacianine) injection — DRUG
    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

Study Details

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.

Key Dates

First listed
Mar 13, 2026
Start date
May 15, 2026
Status verified
Mar 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
106 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Lung dosing 1-24 hours prior to imaging
    Subjects with malignant and non-malignant lesions in the lung dosed with CYTALUX (0.025 mg/kg) 1-24 hours prior to imaging
  • Experimental: Lung dosing 120-168 hours prior to imaging
    Subjects with malignant and non-malignant lesions in the lung dosed with CYTALUX (0.025 mg/kg) 120-168 hours prior to imaging
  • Active Comparator: Ovarian dosing 1-9 hours prior to imaging
    Subjects with ovarian cancer dosed with CYTALUX (0.025 mg/kg) 1-9 hours prior to imaging
  • Experimental: Ovarian dosing 120-168 hours prior to imaging
    Subjects with ovarian cancer dosed with CYTALUX (0.025 mg/kg) 120-168 hours prior to imaging

Primary Outcome Measure

Tumor-to-background ratio [ Time Frame: 1 day ]

Central Contacts

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