Investigating a new imaging agent for lung cancer surgery
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
This study is testing a new imaging agent to see if it can help doctors better see lung tumors during surgery for patients with lung cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Integro Theranostics Industry-sponsored |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06713564 on ClinicalTrials.gov |
What this trial studies
This Phase 1b study aims to evaluate the safety and fluorescence signal of LS301-IT, a novel imaging agent, administered intravenously to patients undergoing surgical thoracoscopy and resection for lung cancer. The study will involve up to 24 patients divided into four dose cohorts, with safety as the primary focus. The fluorescence signal will be assessed in relation to the dose level and timing of administration, helping to visualize tumor margins and suspicious nodules during surgery.
Who should consider this trial
Good fit: Ideal candidates include patients with a primary diagnosis or high suspicion of lung cancer who are scheduled for surgical thoracoscopy and resection.
Not a fit: Patients with contraindications for surgery or those who have had recent exposure to other optical imaging agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of lung cancer surgeries by improving tumor visualization.
How similar studies have performed: Other studies using fluorescence imaging agents have shown promise, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ECOG performance status of 0 to 2 * 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. Exclusion Criteria: * Contraindications for surgery or any medical condition that in the opinion of the investigator could jeopardize the safety of the subject * No planned surgical use of any other fluorescent optical imaging agent, or exposure to another optical imaging agent within 8 weeks prior to surgery History of any drug-related hypersensitivity or anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study, or known shellfish allergies. Known sensitivity to near infrared light Patients with impaired renal function as defined by a creatinine clearance (CrCl) \<60 mL/min at Screening, according to the Cockcroft-Gault formula ((140 - age) × body weight/plasma creatinine × 72 (× 0.85 for female) History, or presence in the ECG at Screening, of any clinically significant abnormalities including cardiac conduction abnormalities such as Fridericia's corrected QTc interval (QTcF) \> 470 ms
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Dan Thompson
- Email: dthompson@integrotheranostics.com
- Phone: 314-325-1800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.