Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of subjects with one or more NIR fluorescence positive lesion not detected under normal light and/or palpation
研究概览
简要总结
The goal of clinical trial is to test an FDA approved drug called Pafolacianine that attaches to cancer cells and lights up when seen through a special camera system in adults with a suspected primary diagnosis, or a high clinical suspicion of gastrointestinal, fore gut, pancreatic, hepatobiliary, esophageal malignancies and gyn malignancies planned for HIPEC/debulking, warranting surgery. The main question it aims to answer is:
• Can CYTALUX™ (pafolacianine) injection used with near-infrared (NIR) fluorescent imaging improve the detection of malignant tissue in subjects undergoing surgical resection for cancer? Participants taking part in this study will receive the study medication. Then, during the surgery the investigator team will turn on the camera to evaluate if the tumor is visible with the help of the study medication. Taking part in this study will last about 2 months.
详细描述
Background and Rationale:
Gastroesophageal and pancreatic cancers are aggressive malignancies with limited curative options. Complete surgical resection (R0) remains the cornerstone of curative intent. However, current intraoperative tools-visual inspection, palpation, and endoscopy-are limited in accurately delineating tumor margins and detecting occult lesions. High recurrence rates after surgery suggest a need for improved intraoperative detection techniques.
Folate receptor-alpha (FRα) is overexpressed in a variety of epithelial tumors, including gastric and pancreatic cancers. Recent studies have demonstrated that over one-third of gastric cancers and a subset of peritoneal metastases from gastrointestinal tumors overexpress FRα, making them amenable to targeted imaging. Pafolacianine is a folate analog conjugated to a near-infrared fluorescent dye designed to bind to FRα, enabling real-time intraoperative visualization of cancerous tissue using NIR imaging systems.
Investigational Product:
CYTALUX™ (pafolacianine) is an intravenously administered imaging agent developed by On Target Laboratories, Inc. It consists of OTL0038, a folate analog conjugated to an indole-cyanine green-like dye. The agent selectively binds FRα and emits fluorescence in the NIR spectrum (excitation: 760-785 nm; emission: 790-815 nm), providing high-contrast imaging during surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Have a primary diagnosis, or a high clinical suspicion, of gastrointestinal, fore gut, pancreatic, hepatobiliary, esophageal malignancies and gyn malignancies planned for HIPEC/debulking, warranting surgery.
- •Are scheduled to undergo surgical intervention for tumor resection or diagnostic laparoscopy for assessment of disease burden.
- •Willingness to stop the use of folate, folic acid, or folate-containing supplements within 48 hours before administration of Cytalux
- •Willingness of research participant or legal guardian/representative to give written informed consent.
排除标准
- •Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
- •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) injection
- •Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
研究组 & 干预措施
CYTALUX™ (pafolacianine) injection group
Single arm study, every patient receives the study intervention.
干预措施: CYTALUX™ (pafolacianine) injection preoperatively (Drug)
结局指标
主要结局
Proportion of subjects with one or more NIR fluorescence positive lesion not detected under normal light and/or palpation
时间窗: Day 1 intra-operatively post intervention
Proportion of subjects who have one or more NIR fluorescence positive lesion not detected under normal light and/or palpation will be measured in this outcome.
次要结局
- Number of lesions that are simultaneously fluorescence positive and cancer positive(Day 1 intra-operatively post intervention)
研究者
John Waters
MD, Assistant Professor, Cardiothoracic Surgery
University of Texas Southwestern Medical Center