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ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting
NCT04241315 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04241315
The ClinicalTrials.gov registry entry for NCT04241315 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is On Target Laboratories, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04241315 reports 12 study locations spanning 10 distinct geographic areas — top geographies include Pennsylvania, Connecticut, Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04241315?
The interventions under investigation include: OTL38 for Injection (DRUG), Near infrared camera imaging system (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04241315?
This trial is sponsored by On Target Laboratories, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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