ELUCIDATE: Enabling LUng Cancer IDentification Using folATE Receptor Targeting (Elucidate)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04241315 |
Recruitment Status :
Recruiting
First Posted : January 27, 2020
Last Update Posted : December 8, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Neoplasms Lung Cancer | Drug: OTL38 for Injection Device: Near infrared camera imaging system | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 130 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Phase 3, Randomized,Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules |
Actual Study Start Date : | March 26, 2020 |
Estimated Primary Completion Date : | April 26, 2021 |
Estimated Study Completion Date : | August 1, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Near-Infrared Imaging group
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
|
Drug: OTL38 for Injection
Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL Device: Near infrared camera imaging system Near infrared camera imaging system |
No Imaging Group
All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging.
|
Drug: OTL38 for Injection
Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL |
- Clinically Significant Events (CSE) [ Time Frame: 1 day ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and Female subjects 18 years of age and older
- Have a primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging
- Are scheduled to undergo surgical thoracoscopy for diagnostic wedge resection followed by anatomic lung resection
- Female subjects of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion
- Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments
Exclusion Criteria:
- Previous exposure to OTL38
- Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
- History of anaphylactic reactions to folate, including synthetic folic acid (pteroylmonoglutamic acid) and contrast agents containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.
- History of allergy to any of the components of OTL38, including folic acid
- A positive serum pregnancy test at Screening or a positive urine pregnancy test on the day of surgery or day of admission for female subjects of childbearing potential
- Clinically significant abnormalities on electrocardiogram (ECG) at screening.
- Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol and follow-up schedule
- Impaired renal function defined as eGFR< 50 mL/min/1.73m2
- Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >2x ULN for total bilirubin except in subjects with Gilbert's syndrome.
- Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of study drug
- Known sensitivity to fluorescent light

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241315
Contact: Aaron J Blouin | 215-908-5866 | ablouin@ontargetlabs.com |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Not yet recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Research Coordinator 617-632-8386 | |
Principal Investigator: Sidharta Gangadharan, MD | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Shari Barnett shbailey@med.umich.edu | |
Principal Investigator: Rishindra Reddy, MD | |
United States, Ohio | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Research Coordinator BOWMANM3@ccf.org | |
Principal Investigator: Sudish Murthy, M.D., Ph.D | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Sunil Singhal, MD 215-615-5864 sunil.singhal@uphs.upenn.edu | |
Principal Investigator: Sunil Singhal, MD | |
University of Pittsburgh Medical Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Julie Ward, BSN 412-647-8583 wardj@upmc.edu | |
Principal Investigator: Interpal Sarkaria, MD | |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Craig DeDegraaf 713-563-9155 cedegra@mdanderson.org | |
Principal Investigator: David Rice, M.B., B.Ch. |
Principal Investigator: | Sunil Singhal, MD | University of Pennsylvania |
Responsible Party: | On Target Laboratories, LLC |
ClinicalTrials.gov Identifier: | NCT04241315 |
Other Study ID Numbers: |
OTL-2019-OTL38-007 |
First Posted: | January 27, 2020 Key Record Dates |
Last Update Posted: | December 8, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | Yes |
Intraoperative Imaging |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |