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NCT06713564 · ClinicalTrials.gov registry record · Phase 1
A Single Dose, Open-Label, Dose-escalation Study of the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer
A Phase 1 study of Lung Cancers, sponsored by Integro Theranostics.
- Active
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06713564: Active Phase 1 study of Lung Cancers, sponsored by Integro Theranostics.
NCT06713564 is a Phase 1 study of Lung Cancers that is active but no longer recruiting, run by Integro Theranostics. The registered enrollment target is 24 participants, below the 177-participant average among 5 other Lung Cancers trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06713564, a Phase 1 study of Lung Cancers, is active but no longer recruiting, sponsored by Integro Theranostics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Dose Limiting Toxicity - Any CTCAE Grade 2, 3, 4, or 5 AE (any treatment emergent sign or symptom) at least possibly related to IMP will be considered a DLT, as well as any other AE deemed clinically relevant by the SRC.
Conditions Studied
Interventions
- DRUG LS301-IT
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-11-07 |
| Est. Completion | 2026-03 |
| Phase | Phase 1 |
What the registry record for NCT06713564 still lists
NCT06713564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 177-participant average among 5 other Lung Cancers trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Lung Cancers appearing as the primary indexed condition, and to 1 intervention - of which LS301-IT is the first listed.
NCT06713564 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06713564 about?
NCT06713564 is a clinical study titled "A Single Dose, Open-Label, Dose-escalation Study of the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer". 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...
What is the current status of trial NCT06713564?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2024-11-07. Estimated completion is 2026-03.
What conditions does trial NCT06713564 study?
This clinical trial studies the following conditions: Lung Cancers.
What interventions are being tested in trial NCT06713564?
The interventions under investigation include: LS301-IT (DRUG).
Who is sponsoring clinical trial NCT06713564?
This trial is sponsored by Integro Theranostics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06713564 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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