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OTL38 for Tumors

Phase 1
Waitlist Available
Led By Sunil Singhal, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This study is evaluating whether a new imaging technique may help detect lung cancer.

Eligible Conditions
  • Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability of the imaging system to detect the expression of the OTL38 in the nodule/mass (i.e tumor) and discern the uptake of the dye by the tumor.
Microscopic examination and immunohistochemistry of tumor
Secondary outcome measures
Incidence rates of all AEs, treatment-emergent adverse events (TEAEs) and adverse device events (ADEs) from time of OTL38 administration through participants' first, post-operative appointment with surgeon.

Side effects data

From 2020 Phase 3 trial • 140 Patients • NCT03180307
18%
Nausea
5%
Vomiting
5%
Abdominal pain
2%
Acute kidney injury
2%
Postoperative ileus
1%
Peritonitis
1%
Sepsis
1%
Vaginal cuff dehiscence
1%
Post procedural haemorrhage
1%
Metabolic acidosis
1%
Renal impairment
1%
Pneumonia
1%
Anastomotic leak
1%
Postoperative wound infection
1%
Septic shock
1%
Acute respiratory distress syndrome
1%
Acute respiratory failure
1%
Ischaemic stroke
1%
Abscess
1%
Hypoxia
1%
Cholelithiasis
1%
Clostridium difficile infection
1%
Sinus tachycardia
1%
Hyponatraemia
1%
Diverticular perforation
1%
Gastric perforation
1%
Hypoalbuminaemia
1%
Supraventricular tachycardia
1%
Anaemia
1%
Hypovolaemic shock
1%
Pleural effusion
1%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Safety Analysis Set

Trial Design

1Treatment groups
Experimental Treatment
Group I: OTL38Experimental Treatment1 Intervention
Dosage calculated by weight of individual
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OTL38
2018
Completed Phase 3
~470

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,879,826 Total Patients Enrolled
Sunil Singhal, MDPrincipal InvestigatorUniversity of Pennsylvania
6 Previous Clinical Trials
328 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Intraoperative Imaging of Pulmonary Nodules by OTL38
2015. "Intraoperative Imaging of Pulmonary Nodules by OTL38". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02602119.
~26 spots leftby Apr 2025
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