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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.

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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.

Conditions Studied

Lung Cancer Lung Neoplasms

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

FieldValue
Enrollment Target 112 participants
Start Date 2020-03-26
Est. Completion 2021-11-01
Phase Phase 3

Sponsor

On Target Laboratories

4 total trials

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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, categorized as Phase 3. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (88% lower). The listed sponsor is On Target Laboratories, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 12 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.