NCT07469202Not yet recruitingPhase 4
CYTALUX Dose Extension Study
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
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- First submitted
- 9 Mar 2026
- Start date
- 15 Aug 2026
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- On Target Laboratories, LLC
- Diseases
- Lung cancer, Ovarian cancer
- NCT number
- NCT07469202
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 106
- From 15 Aug 2026 to the primary completion date, 28 Feb 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.
- History of allergy to any of the components of Cytalux™ (pafolacianine)
- Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
Lab values
- Impaired renal function defined as eGFR\< 50 mL/min/1.73m2
- Impaired liver function defined as values \> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>2x ULN for total bilirubin excluding those patients with Gilbert's syndrome
Other
- Known sensitivity to fluorescent light
- Pregnant and/or lactating women
- Administration of folate, folic acid, or folate-containing supplements 48 hours before administration of Cytalux™ (pafolacianine)
Who the study is looking for
- Male and female patients 18 years of age and older
- Primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging obtained within 4 months of the screening visit, or have a primary diagnosis for ovarian cancer
- Scheduled to undergo surgical thoracoscopy for wedge resection or anatomic lung resection, or ovarian cancer debulking/cytoreduction
- Willingness of research participant or legal guardian/representative to give written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.