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NCT04241315 · ClinicalTrials.gov registry record · Phase 3
ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting
A Phase 3 study of Lung Cancer and Lung Neoplasms, sponsored by On Target Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 112
- Enrollment target
- 12
- Study locations
NCT04241315: Completed Phase 3 study of Lung Cancer and Lung Neoplasms, sponsored by On Target Laboratories.
NCT04241315 is a Phase 3 study of Lung Cancer and Lung Neoplasms that has completed, run by On Target Laboratories. The registered enrollment target is 112 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (88% lower). The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04241315, a Phase 3 study of Lung Cancer and Lung Neoplasms, has completed, sponsored by On Target Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 112 participants
- Enrollment target
- 12
- Study locations
Study Summary
This is a phase 3, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/PET/MRI or other imaging based on standard of care. This study aims to assess the efficacy of OTL38 and Near Infrared Imaging (NIR) at identifying pulmonary nodules within the operating theater, and to assess the safety and tolerability of single intravenous doses of OTL38.
Primary Outcome
The primary efficacy endpoint is the proportion of patients who demonstrate at least one CSE as a result of utilizing OTL-38 and Near Infrared Imaging.
Conditions Studied
Interventions
- DRUG OTL38 for Injection
- DEVICE Near infrared camera imaging system
Study Locations (12)
Pennsylvania
- University of Pennsylvania - Philadelphia
- Allegheny General Hospital - Pittsburgh
- University of Pittsburgh Medical Center - Pittsburgh
Connecticut
- Stamford - Stamford
Iowa
- University of Iowa - Iowa City
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Michigan
- University of Michigan - Ann Arbor
Minnesota
- Mayo Clinic - Rochester
Ohio
- Cleveland Clinic - Cleveland
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2020-03-26 |
| Est. Completion | 2021-11-01 |
| Phase | Phase 3 |
What the finished NCT04241315 record still lists
NCT04241315 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which OTL38 for Injection is the first listed.
NCT04241315 lists 12 locations in 10 states (Pennsylvania, Connecticut, Iowa).
Frequently Asked Questions
What is clinical trial NCT04241315 about?
NCT04241315 is a clinical study titled "ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting". This is a phase 3, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/PET/MRI or other imaging based on standard of care. This study aims to assess the efficacy of OTL38 and Near Infrared Imaging (NIR)...
What is the current status of trial NCT04241315?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2020-03-26. Estimated completion is 2021-11-01.
What conditions does trial NCT04241315 study?
This clinical trial studies the following conditions: Lung Cancer, Lung Neoplasms.
What interventions are being tested in trial NCT04241315?
The interventions under investigation include: OTL38 for Injection (DRUG), Near infrared camera imaging system (DEVICE).
Who is sponsoring clinical trial NCT04241315?
This trial is sponsored by On Target Laboratories, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04241315 being conducted?
This trial has 12 study locations across Connecticut, Iowa, Massachusetts, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04241315's enrollment target sits among peer trials
112 176th of 409 higher than 233 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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