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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 106
- 主要终点
- Tumor-to-background ratio
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Known sensitivity to fluorescent light
- •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
- •Pregnant and/or lactating women
- •Administration of folate, folic acid, or folate-containing supplements 48 hours before administration of Cytalux™ (pafolacianine)
研究组 & 干预措施
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
干预措施: CYTALUX (pafolacianine) injection (Drug)
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
干预措施: CYTALUX (pafolacianine) injection (Drug)
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
干预措施: CYTALUX (pafolacianine) injection (Drug)
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
干预措施: CYTALUX (pafolacianine) injection (Drug)
结局指标
主要结局
Tumor-to-background ratio
时间窗: 1 day
Mean difference in in-situ tumor-to-background ratio (TBR) between 120-168 hours and the approved window
次要结局
- Sensitivity(1 day)
- Sensitivity of folate receptor-positive lesions(1 day)