Efficacy and Safety of a Single Dose of LS301-IT for Fluorescence Intraoperative Molecular Imaging (IMI) for Patients Undergoing Lung Cancer Resection for Non Small Cell Lung Cancer

Официальное название

A Phase 2, Open-Label, Multicenter Study to Investigate the Efficacy and Safety of a Single Dose of LS301-IT for Fluorescence Intraoperative Molecular Imaging (IMI) for Lung Cancer Resection

Обзор

The aim of this Phase 2 study is to investigate the efficacy and safety of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by intravenous (IV) infusion in patients undergoing VATS (Video-Assisted Thoracoscopic Surgery) or RATS (Robotic-Assisted Thoracoscopic Surgery) resection of Stage I-II non-small cell lung cancer (NSCLC).

Подробное описание

The primary objective of the study is to determine the proportion of subjects that have at least one Clinically Significant Event (CSE) using fluorescence imaging, defined as either the localization of the primary tumor when white light has failed to identify the tumor, the identification of a synchronous or occult pulmonary tumor with fluorescence only, or the identification of an inadequate surgical margin after resection. Secondary objectives include the determination of the sensitivity and positive predictive value (PPV) of LS301 fluorescence imaging in the identification of tumor using histopathology as the gold standard, and the assessment of the safety and tolerability of LS301-IT. Exploratory objectives include the determination of the "Clinical Impact Rate" defined as the proportion of cases when the surgeon changes the scope of the procedure based on LS301 fluorescence imaging, the assessment of the dosing interval prior to surgery, and the standardization of imaging during surgery and surgeon assessment of fluorescence.

Вмешательства

• Препарат LS301-IT 0.1 mg/kg
  Single dose of LS301-IT administed up to 4 days prior to surgery

Первичные конечные точки

• Clinically Significant Events [Срок оценки: On the day of surgery]

Вторичные конечные точки (6)

• Sensitivity [Срок оценки: day or surgery]
• Positive Predictive Value [Срок оценки: day of surgery]
• Primary tumor identification rate [Срок оценки: day of surgery]
• Synchronous or occult tumor identification rate [Срок оценки: day of surgery]
• Close margin rate [Срок оценки: day of surgery]
• Incidence of Adverse Events [Срок оценки: within 30 days after dosing]

Критерии участия

Критерии включения

• Have a primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
• Are scheduled to undergo surgical thoracoscopy and resection of the lung.
• If of childbearing potential, the patient must have a negative serum pregnancy test at screening, on Day 1 prior to LS301-IT administration, as well as using a medically acceptable form of contraception (eg, hormonal birth control, double-barrier method) or abstinence.
• Ability to understand the requirements of the study

Критерии исключения

• Contraindications for surgery or any medical condition that in the opinion of the investigator could jeopardize the safety of the subject
• History of any drug-related hypersensitivity or anaphylactic reactions, including those attributed to indocyanine green (ICG) or other contrast agents.
• Patients with impaired renal function
• History, or presence in the ECG at Screening, of any clinically significant abnormalities including cardiac conduction abnormalities
• History of radiation therapy to the chest
• Total bilirubin level >1.5 times upper limit
• Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) > 2.5 times the upper limit of normal (ULN)
• Patient is pregnant or breast feeding

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 2 центра

• University of Pennsylvania — Philadelphia
• University of Texas Southwestern Medical Center — Dallas

Идентификаторы

NCT: NCT07276789 · LS301-IT-B201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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