CYTALUX Dose Extension Study

Overview

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.

This is a prospective, multicenter, open-label, non-inferiority study designed to evaluate the clinical adequacy of intraoperative tumor fluorescence following administration of Cytalux™ (pafolacianine) injection at two different administration time windows in adult subjects undergoing surgery for known or suspected cancer in the lung or ovarian cancer. The study will enroll adult patients with either malignant or non-malignant lung lesions with known or suspected lung cancer, or patients with a confirmed diagnosis of ovarian cancer, who are scheduled to undergo surgical resection. Cytalux™ (pafolacianine) injection is an FDA-approved optical imaging agent indicated as an adjunct for intraoperative identification of malignant and non-malignant pulmonary lesions in adults with known or suspected lung cancer, and for malignant lesions in adults with ovarian cancer. Eligible participants will receive a single intravenous dose of Cytalux™ at the FDA-approved dose of 0.025 mg/kg. The dose level will remain consistent with the approved labeling. Participants will be assigned to one of two dosing windows. During surgery, intraoperative molecular imaging will be performed to assess tumor fluorescence following administration of Cytalux™. The primary objective of the study is to demonstrate non-inferiority of Cytalux™ administration within an extended dosing window of 120-168 hours prior to surgery compared with the currently approved administration windows (lung: 1-24 hours; ovarian: 1-9 hours).

Conditions

Interventions

Eligibility

Outcomes

Central Contacts