ACTIVE_NOT_RECRUITING

A Single Dose, Open-Label, Dose-escalation Study of the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) administration in patients undergoing surgical thoracoscopy and resection of lung cancer. Safety is the primary objective of this study, followed by the evaluation of the fluorescence signal as it relates to dose level and dosing time interval.

Official Title

A Phase 1b, Single Dose, Open-Label, Dose-escalation Study to Investigate the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer

Quick Facts

Study Start:2024-11-07
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06713564

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ECOG performance status of 0 to 2
  2. * Have a primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
  3. * Are scheduled to undergo surgical thoracoscopy and resection of the lung.
  1. * Contraindications for surgery or any medical condition that in the opinion of the investigator could jeopardize the safety of the subject
  2. * No planned surgical use of any other fluorescent optical imaging agent, or exposure to another optical imaging agent within 8 weeks prior to surgery

Contacts and Locations

Principal Investigator

Robert Honigberg, MD
STUDY_DIRECTOR
Integro Theranostics

Study Locations (Sites)

University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Integro Theranostics

  • Robert Honigberg, MD, STUDY_DIRECTOR, Integro Theranostics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-07
Study Completion Date2025-10

Study Record Updates

Study Start Date2024-11-07
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • lung cancer imaging
  • lung cancer surgery

Additional Relevant MeSH Terms

  • Lung Cancers