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CompletedNCT03180307Updated Feb 4, 2022Results posted

OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer

A Phase 3 interventional study of OTL38 and near infrared camera imaging system in Ovarian Cancer, sponsored by On Target Laboratories, LLC. Completed at 11 sites in 2 countries. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-02-04.

Sponsored by On Target Laboratories, LLC · Phase 3, Interventional, and Other

Phase
Phase 3
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
Female
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Study summary

This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.

Read the detailed description

The Phase 3 study is to confirm the efficacy of OTL38 in combination with fluorescent light to detect additional Folate Receptor-positive (FR+) ovarian cancer lesions not detected by palpation and visualization under normal light in patients with FR+ ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

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Conditions studied

  • Ovarian Cancer
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 140 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

On Target Laboratories, LLC is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Female patients 18 years of age and older

  • Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer surgery, and:

    • Who are scheduled to undergo laparotomy for the debulking surgery OR
    • Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery if cancer is detected on the laparoscopy
  • A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential
  • Female patients 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 for participation in the study 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

Exclusion Criteria:

  • Previous exposure to OTL38
  • Known FR-negative ovarian cancer
  • Planned surgical debulking via laparoscopy or robotic surgery, with no intent of laparotomy.
  • Patients with known ovarian cancer miliary disease determined preoperatively to be inoperable.
  • Any medical condition that, in the opinion of the investigators, could potentially jeopardize the safety of the patient
  • History of anaphylactic reactions
  • History of allergy to any of the components of OTL38, including folic acid
  • Pregnancy or positive pregnancy test
  • Clinically significant abnormalities on electrocardiogram (ECG)
  • Presence of any psychological, familial, sociological or geographical condition 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), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin.
  • Known Stage IV ovarian cancer with brain metastases
  • Received an investigational agent in another clinical trial within 30 days prior to surgery
  • Known sensitivity to fluorescent light
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Study design

Phase
Phase 3
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (actual)

Study arms

  • Sham comparator
    no fluorescent imaging

    Patient injected with OTL38, but does not undergo fluorescent imaging

    Drug: OTL38 · Procedure: laparotomy

  • Experimental
    near infrared imaging arm

    Patient injected with OTL38 and undergoes near infrared imaging

    Drug: OTL38 · Device: near infrared camera imaging system · Procedure: laparotomy

Interventions

  • DrugOTL38

    0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes

    Also known as: OTL38 for Injection

  • Devicenear infrared camera imaging system

    Infrared imaging used to excite OTL38 for fluorescence

    Also known as: Near IR imaging

  • Procedurelaparotomy

    primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

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What researchers measure

Primary outcomes

  1. Efficacy Patient Level

    Percentage of patients with at least one evaluable FR+ ovarian cancer lesion confirmed by central pathology (Standard of truth) that was detected using the combination of OTL38 and fluorescent light but not under normal light or palpation (Full Analysis Set)

    Time frame: 30 days

Secondary outcomes

  1. Patient False Positive Rate

    False Positive Rate at the patient level (FPRp) will be a major secondary efficacy endpoint and is defined as the percentage of women who underwent both normal light and fluorescent light (Intent-to-Image Set)

    Time frame: 30 days

07

Results

Posted Feb 4, 2022

Participant flow

Participant flow — Overall Study
MilestoneExperimental: OTL38 Injection and Near Infrared ImagingSham Comparator: OTL38 Injection and No Fluorescent Imaging
Started1346
Safety analysis set13416
Full analysis set/ intent to image set1340
Per protocol analysis set1060
Pharmacokinetic analysis set1226
Completed1286
Not completed60
Withdrew: Lost to follow-up20
Withdrew: Death10
Withdrew: Majority of which were disease too extensive and camera not used30

Outcome measures

PrimaryEfficacy Patient Level

Percentage of patients with at least one evaluable FR+ ovarian cancer lesion confirmed by central pathology (Standard of truth) that was detected using the combination of OTL38 and fluorescent light but not under normal light or palpation (Full Analysis Set)

Time frame:
30 days
Reported as:
Number · percentage of participants
Efficacy Patient Level
percentage of participantsFull Analysis Set
Efficacy Patient Level26.9 (19.6 to 35.2)
SecondaryPatient False Positive Rate

False Positive Rate at the patient level (FPRp) will be a major secondary efficacy endpoint and is defined as the percentage of women who underwent both normal light and fluorescent light (Intent-to-Image Set)

Time frame:
30 days
Reported as:
Number · percentage of participants
Patient False Positive Rate
percentage of participantsFull Analysis Set
Patient False Positive Rate20.2 (13.7 to 28.0)

Adverse events

Collected over Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Safety Analysis Set2/150 (1.3%)22/150 (14.7%)34/150 (22.7%)
Most frequent serious events
Showing 10 of 31
Most frequent serious events
EventSafety Analysis Set
Postoperative ileusInjury, poisoning and procedural complications3/150
Acute kidney injuryRenal and urinary disorders3/150
Septic shockInfections and infestations2/150
Pleural effusionRespiratory, thoracic and mediastinal disorders2/150
AbscessInfections and infestations1/150
Clostridium difficile infectionInfections and infestations1/150
PeritonitisInfections and infestations1/150
PneumoniaInfections and infestations1/150
Postoperative wound infectionImmune system disorders1/150
SepsisInfections and infestations1/150
Most frequent other events
Most frequent other events
EventSafety Analysis Set
NauseaGastrointestinal disorders27/150
VomitingGastrointestinal disorders8/150
Abdominal painGastrointestinal disorders7/150

Baseline characteristics

Age, Continuous
Age, Continuous(years)Experimental: OTL38 Injection and Near Infrared ImagingSham Comparator: OTL38 Injection and No Fluorescent ImagingTotal
Mean60.4 ± 10.9162.8 ± 21.7760.8 ± 11.39
Sex: Female, Male
Sex: Female, Male(Participants)Experimental: OTL38 Injection and Near Infrared ImagingSham Comparator: OTL38 Injection and No Fluorescent ImagingTotal
Female1346140
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Experimental: OTL38 Injection and Near Infrared ImagingSham Comparator: OTL38 Injection and No Fluorescent ImagingTotal
Hispanic or Latino15217
Not Hispanic or Latino1164120
Unknown or Not Reported303
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Experimental: OTL38 Injection and Near Infrared ImagingSham Comparator: OTL38 Injection and No Fluorescent ImagingTotal
American Indian or Alaska Native404
Asian516
Native Hawaiian or Other Pacific Islander000
Black or African American707
White1145119
More than one race000
Unknown or Not Reported404
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Study locations

11 sites
  • The Mayo Clinic - Phoenix
    Phoenix, Arizona 85054, United States
  • University of Arizona
    Tucson, Arizona 85724, United States
  • City of Hope Medical Center
    Duarte, California 91010, United States
  • University of CA at Irvine Chao Cancer Center
    Orange, California 92868, United States
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
  • Karmanos Cancer Institutes
    Detroit, Michigan 48201, United States
  • Mayo Clinic-Rochester
    Rochester, Minnesota 55905, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63108, United States
  • Kettering Medical Center
    Kettering, Ohio 45427, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Leiden University Medical Center
    Leiden, South Holland 2333 ZA, Netherlands
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References and documents

Study documents

  • Study protocol · Nov 27, 2018
  • Statistical analysis plan · May 16, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03180307
Lead sponsor
On Target Laboratories, LLC
Collaborators
SynteractHCR
Responsible party
Sponsor
First posted
Jun 8, 2017
Start date
Jan 26, 2018
Primary completion
Apr 16, 2020
Completion
Oct 16, 2020
Results posted
Feb 4, 2022
Last update
Feb 4, 2022

Study contacts

Janos Tanyi, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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