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Cytalux Administration Windows in Lung and Ovarian Cancer Surgery
NCT07469202Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Aug 2026
- Primary completion
- Feb 2027
- Sponsor
- On Target Laboratories
- Drugs
- pafolacianine
- Conditions
- lung cancerovarian cancer
01
Overview
Phase 4, open-label trial of pafolacianine in lung cancer and ovarian cancer (4 arms), sponsored by On Target Laboratories. Primary endpoint: Tumor-to-background ratio at 1 day. Planned start Aug 2026; status: not yet recruiting.
02
Design
4 arms- Study design
- Open-label
Lung dosing 1-24 hours prior
Subjects with lung lesions dosed with CYTALUX 1-24 hours prior to imaging
Lung dosing 120-168 hours prior
Subjects with lung lesions dosed with CYTALUX 120-168 hours prior to imaging
Ovarian dosing 1-9 hours prior
Subjects with ovarian cancer dosed with CYTALUX 1-9 hours prior to imaging
Ovarian dosing 120-168 hours prior
Subjects with ovarian cancer dosed with CYTALUX 120-168 hours prior to imaging
03
Who it enrols
Adults with known or suspected lung cancer or confirmed ovarian cancer scheduled for surgery, with adequate renal and hepatic function, excluding those with allergies to indocyanine green or Cytalux, pregnant/lactating women, and those who took folate supplements within 48 hours.
04
Endpoints
Primary
Tumor-to-background ratio
Secondary
Sensitivity
Sensitivity of folate receptor-positive lesions
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