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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03180307
Recruitment Status : Completed
First Posted : June 8, 2017
Results First Posted : February 4, 2022
Last Update Posted : February 4, 2022
Sponsor:
Collaborator:
SynteractHCR
Information provided by (Responsible Party):
On Target Laboratories, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Ovarian Cancer
Interventions Drug: OTL38
Device: near infrared camera imaging system
Procedure: laparotomy
Enrollment 140
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental: OTL38 Injection and Near Infrared Imaging Sham Comparator: OTL38 Injection and No Fluorescent Imaging
Hide Arm/Group Description

Patient injected with OTL38 and undergoes near infrared imaging.

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

Other Names:

OTL38 for Injection Device: near infrared camera imaging system Infrared imaging used to excite OTL38 for fluorescence

Other Names:

Near IR imaging Procedure/Surgery: laparotomy primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

Patient injected with OTL38, but does not undergo fluorescent imaging.

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

Other Names:

OTL38 for Injection Procedure/Surgery: laparotomy primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

Period Title: Overall Study
Started 134 6
Safety Analysis Set [1] 134 16
Full Analysis Set/ Intent to Image Set 134 0
Per Protocol Analysis Set 106 0
Pharmacokinetic Analysis Set 122 6
Completed 128 6
Not Completed 6 0
Reason Not Completed
Lost to Follow-up             2             0
Death             1             0
Majority of which were disease too extensive and camera not used             3             0
[1]
All subjects received study drug prior to randomization. A total of 150 subjects received study drug, 10 of which were not randomized to either arm. These 10 subjects withdrew to the study prior to randomization but are included in the Safety Analysis Set.
Arm/Group Title Experimental: OTL38 Injection and Near Infrared Imaging Sham Comparator: OTL38 Injection and No Fluorescent Imaging Total
Hide Arm/Group Description

Patient injected with OTL38 and undergoes near infrared imaging.

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

Other Names:

OTL38 for Injection Device: near infrared camera imaging system Infrared imaging used to excite OTL38 for fluorescence

Other Names:

Near IR imaging Procedure/Surgery: laparotomy primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

Patient injected with OTL38, but does not undergo fluorescent imaging.

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

Other Names:

OTL38 for Injection

Procedure/Surgery: laparotomy primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

Total of all reporting groups
Overall Number of Baseline Participants 134 6 140
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 134 participants 6 participants 140 participants
60.4  (10.91) 62.8  (21.77) 60.8  (11.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 6 participants 140 participants
Female
134
 100.0%
6
 100.0%
140
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 6 participants 140 participants
Hispanic or Latino
15
  11.2%
2
  33.3%
17
  12.1%
Not Hispanic or Latino
116
  86.6%
4
  66.7%
120
  85.7%
Unknown or Not Reported
3
   2.2%
0
   0.0%
3
   2.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants 6 participants 140 participants
American Indian or Alaska Native
4
   3.0%
0
   0.0%
4
   2.9%
Asian
5
   3.7%
1
  16.7%
6
   4.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
   5.2%
0
   0.0%
7
   5.0%
White
114
  85.1%
5
  83.3%
119
  85.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   3.0%
0
   0.0%
4
   2.9%
1.Primary Outcome
Title Efficacy Patient Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full Analysis Set
Hide Arm/Group Description:

Patients exposed to OTL38 and who were randomly assigned to undergo NIR fluorescent imaging (OTL38+imaging) and who:

  • Were evaluated under both normal light and NIR fluorescent light imaging
  • Had central pathology and histology confirmation for at least one FR+ ovarian cancer lesion detected under normal light or NIR fluorescent light imaging
Overall Number of Participants Analyzed 134
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.9
(19.6 to 35.2)
2.Secondary Outcome
Title Patient False Positive Rate
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full Analysis Set
Hide Arm/Group Description:

Patients exposed to OTL38 and who were randomly assigned to undergo NIR fluorescent imaging (OTL38+imaging) and who:

  • Were evaluated under both normal light and NIR fluorescent light imaging
  • Had central pathology and histology confirmation for at least one FR+ ovarian cancer lesion detected under normal light or NIR fluorescent light imaging
Overall Number of Participants Analyzed 134
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.2
(13.7 to 28.0)
Time Frame Incidence rates of treatment-emergent AEs (TEAEs), SAEs, and Adverse Device Effects (ADEs) Visit 1 (screening) through Visit 4 (28 days +/- 7 days).
Adverse Event Reporting Description The "Other Adverse Events" table captures all drug-related treatment-emergent adverse events reported at or above the frequency threshold for reporting.
 
Arm/Group Title Safety Analysis Set
Hide Arm/Group Description The Safety Analysis Set includes all subjects who received any amount of study drug.
All-Cause Mortality
Safety Analysis Set
Affected / at Risk (%)
Total   2/150 (1.33%) 
Hide Serious Adverse Events
Safety Analysis Set
Affected / at Risk (%)
Total   22/150 (14.67%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/150 (0.67%) 
Cardiac disorders   
Sinus tachycardia * 1  1/150 (0.67%) 
Supraventricular tachycardia * 1  1/150 (0.67%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/150 (0.67%) 
Diverticular perforation * 1  1/150 (0.67%) 
Gastric perforation * 1  1/150 (0.67%) 
Vomiting * 1  1/150 (0.67%) 
Hepatobiliary disorders   
Cholelithiasis * 1  1/150 (0.67%) 
Immune system disorders   
Postoperative wound infection * 1  1/150 (0.67%) 
Infections and infestations   
Septic shock * 1  2/150 (1.33%) 
Abscess * 1  1/150 (0.67%) 
Clostridium difficile infection * 1  1/150 (0.67%) 
Peritonitis * 1  1/150 (0.67%) 
Pneumonia * 1  1/150 (0.67%) 
Sepsis * 1  1/150 (0.67%) 
Injury, poisoning and procedural complications   
Postoperative ileus * 1  3/150 (2.00%) 
Anastomotic leak * 1  1/150 (0.67%) 
Post procedural haemorrhage * 1  1/150 (0.67%) 
Vaginal cuff dehiscence * 1  1/150 (0.67%) 
Metabolism and nutrition disorders   
Hypoalbuminaemia * 1  1/150 (0.67%) 
Hyponatraemia * 1  1/150 (0.67%) 
Metabolic acidosis * 1  1/150 (0.67%) 
Nervous system disorders   
Ischaemic stroke * 1  1/150 (0.67%) 
Renal and urinary disorders   
Acute kidney injury * 1  3/150 (2.00%) 
Renal impairment * 1  1/150 (0.67%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion * 1  2/150 (1.33%) 
Acute respiratory distress syndrome * 1  1/150 (0.67%) 
Acute respiratory failure * 1  1/150 (0.67%) 
Hypoxia * 1  1/150 (0.67%) 
Vascular disorders   
Hypotension * 1  1/150 (0.67%) 
Hypovolaemic shock * 1  1/150 (0.67%) 
1
Term from vocabulary, MedDRA (20.1)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Safety Analysis Set
Affected / at Risk (%)
Total   34/150 (22.67%) 
Gastrointestinal disorders   
Nausea * 1  27/150 (18.00%) 
Vomiting * 1  8/150 (5.33%) 
Abdominal pain * 1  7/150 (4.67%) 
1
Term from vocabulary, MedDRA (20.1)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tommy Lee, MSHS, Vice President, Clinical Operations
Organization: On Target Laboratories
Phone: 765-588-4547
EMail: Tlee@ontargetlabs.com
Layout table for additonal information
Responsible Party: On Target Laboratories, LLC
ClinicalTrials.gov Identifier: NCT03180307    
Other Study ID Numbers: OTL-2016-OTL38-006
First Submitted: June 6, 2017
First Posted: June 8, 2017
Results First Submitted: October 14, 2021
Results First Posted: February 4, 2022
Last Update Posted: February 4, 2022