Trial Outcomes & Findings for OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules (NCT NCT02872701)
NCT ID: NCT02872701
Last Updated: 2023-03-24
Results Overview
Sensitivity or True Positive Rate (TPR) for OTL38 in combination with fluorescent light, defined as the proportion of fluorescent light positive tissue samples (nodule, synchronous lesion, and margin but excluding lymph nodes) that are histologically confirmed to be FR+ and lung cancer by central pathology relative to the total number of tissue samples confirmed to be FR+ and lung cancer by central pathology. Sensitivity = (True Positive)/(True Positive +False Negative)
COMPLETED
PHASE2
100 participants
1 day
2023-03-24
Participant Flow
Participant milestones
| Measure |
Patients Receiving OTL38
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
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
Near infrared camera imaging system: Near infrared camera imaging system
Endoscopic or Thoracic Surgery: Endoscopic or Thoracic Surgery
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
97
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
Baseline characteristics by cohort
| Measure |
Patients Receiving OTL38
n=100 Participants
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
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
Near infrared camera imaging system: Near infrared camera imaging system
Endoscopic or Thoracic Surgery: Endoscopic or Thoracic Surgery
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
72 Participants
n=5 Participants
|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
90 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: The FAS for the analysis of the two co-primary endpoints, sensitivity and FPR, included patients exposed to OTL38 who: * Were evaluated under both normal light and fluorescent light imaging, and * Had central pathology and histology confirmation (positive for FR+ Lung Cancer) for at least one tissue sample detected under normal light or fluorescent light imaging
Sensitivity or True Positive Rate (TPR) for OTL38 in combination with fluorescent light, defined as the proportion of fluorescent light positive tissue samples (nodule, synchronous lesion, and margin but excluding lymph nodes) that are histologically confirmed to be FR+ and lung cancer by central pathology relative to the total number of tissue samples confirmed to be FR+ and lung cancer by central pathology. Sensitivity = (True Positive)/(True Positive +False Negative)
Outcome measures
| Measure |
Patients Receiving OTL38
n=107 Lesions
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
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
Near infrared camera imaging system: Near infrared camera imaging system
Endoscopic or Thoracic Surgery: Endoscopic or Thoracic Surgery
|
|---|---|
|
Sensitivity or True Positive Rate (TPR)
|
0.854 proportion of lesions
Interval 0.74 to 0.92
|
PRIMARY outcome
Timeframe: 1 dayPopulation: The FAS for the analysis of the two co-primary endpoints, sensitivity and FPR, included patients exposed to OTL38 who: * Were evaluated under both normal light and fluorescent light imaging, and * Had central pathology and histology confirmation (positive for FR+ Lung Cancer) for at least one tissue sample detected under normal light or fluorescent light imaging
False positive rate (FPR) for OTL38 in combination with fluorescent light, for the purpose of this protocol, will be calculated as 1 - the Positive Predictive Value (PPV) and is defined as the proportion of fluorescent light positive tissue samples removed (nodule, synchronous lesion, and margin but excluding lymph nodes) that are histologically confirmed to be non-cancerous, or if cancerous, not FR+ and lung cancer, by central pathology relative to the total number of tissue samples removed with fluorescent light imaging. False Positive Rate = (False Positives) / (True Positives + False Positives)
Outcome measures
| Measure |
Patients Receiving OTL38
n=107 Lesions
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
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
Near infrared camera imaging system: Near infrared camera imaging system
Endoscopic or Thoracic Surgery: Endoscopic or Thoracic Surgery
|
|---|---|
|
False Positive Rate (FPR)
|
0.138 proportion of lesions
Interval 0.08 to 0.23
|
SECONDARY outcome
Timeframe: 1 dayPopulation: The FAS for the analysis of the two co-primary endpoints, sensitivity and FPR, included patients exposed to OTL38 who: * Were evaluated under both normal light and fluorescent light imaging, and * Had central pathology and histology confirmation (positive for FR+ Lung Cancer) for at least one tissue sample detected under normal light or fluorescent light imaging
Proportion of patients with at least 1 Clinically Significant Event (CSE as a result of utilizing OLT-38 and Near Infrared Imaging
Outcome measures
| Measure |
Patients Receiving OTL38
n=75 Participants
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
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
Near infrared camera imaging system: Near infrared camera imaging system
Endoscopic or Thoracic Surgery: Endoscopic or Thoracic Surgery
|
|---|---|
|
Proportion of Patients With at Least 1 Clinically Significant Event (CSE)
|
0.293 proportion of participants
Interval 0.194 to 0.41
|
SECONDARY outcome
Timeframe: 1 dayPopulation: The FAS for the analysis of the two co-primary endpoints, sensitivity and FPR, included patients exposed to OTL38 who: * Were evaluated under both normal light and fluorescent light imaging, and * Had central pathology and histology confirmation (positive for FR+ Lung Cancer) for at least one tissue sample detected under normal light or fluorescent light imaging
Number of patients where at least one positive margin (fluorescent cancerous cells within 5 mm of the staple line) is identified with only OTL-38 and NIR
Outcome measures
| Measure |
Patients Receiving OTL38
n=75 Participants
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
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
Near infrared camera imaging system: Near infrared camera imaging system
Endoscopic or Thoracic Surgery: Endoscopic or Thoracic Surgery
|
|---|---|
|
Positive Margin Identification
|
8 Participants
|
SECONDARY outcome
Timeframe: 1 dayPopulation: The FAS for the analysis of the two co-primary endpoints, sensitivity and FPR, included patients exposed to OTL38 who: * Were evaluated under both normal light and fluorescent light imaging, and * Had central pathology and histology confirmation (positive for FR+ Lung Cancer) for at least one tissue sample detected under normal light or fluorescent light imaging
Number of patients where at least one synchronous lesions is identified only with OTL-38 and NIR
Outcome measures
| Measure |
Patients Receiving OTL38
n=75 Participants
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
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
Near infrared camera imaging system: Near infrared camera imaging system
Endoscopic or Thoracic Surgery: Endoscopic or Thoracic Surgery
|
|---|---|
|
Synchronous Lesion Identification
|
7 Participants
|
SECONDARY outcome
Timeframe: 1 dayPopulation: The FAS for the analysis of the two co-primary endpoints, sensitivity and FPR, included patients exposed to OTL38 who: * Were evaluated under both normal light and fluorescent light imaging, and * Had central pathology and histology confirmation (positive for FR+ Lung Cancer) for at least one tissue sample detected under normal light or fluorescent light imaging
Number of pulmonary nodules identified with OTL-38 and Near Infrared Imaging (NIR) that could not otherwise be identified by white light and palpation.
Outcome measures
| Measure |
Patients Receiving OTL38
n=75 Participants
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
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
Near infrared camera imaging system: Near infrared camera imaging system
Endoscopic or Thoracic Surgery: Endoscopic or Thoracic Surgery
|
|---|---|
|
Pulmonary Nodule Identification
|
10 number of pulmonary nodules
|
Adverse Events
Patients Receiving OTL38
Serious adverse events
| Measure |
Patients Receiving OTL38
n=100 participants at risk
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
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
Near infrared camera imaging system: Near infrared camera imaging system
Endoscopic or Thoracic Surgery: Endoscopic or Thoracic Surgery
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
2.0%
2/100 • Number of events 2 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
2/100 • Number of events 2 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
2/100 • Number of events 2 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
1.0%
1/100 • Number of events 1 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
1.0%
1/100 • Number of events 1 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
1/100 • Number of events 1 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.0%
1/100 • Number of events 1 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Infections and infestations
Pneumonia
|
2.0%
2/100 • Number of events 2 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.0%
1/100 • Number of events 1 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.0%
1/100 • Number of events 1 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.0%
1/100 • Number of events 2 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Vascular disorders
Arterial haemorrhage
|
1.0%
1/100 • Number of events 1 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
Other adverse events
| Measure |
Patients Receiving OTL38
n=100 participants at risk
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
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
Near infrared camera imaging system: Near infrared camera imaging system
Endoscopic or Thoracic Surgery: Endoscopic or Thoracic Surgery
|
|---|---|
|
Injury, poisoning and procedural complications
Procedural pain
|
50.0%
50/100 • Number of events 50 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Injury, poisoning and procedural complications
Incision site pain
|
20.0%
20/100 • Number of events 20 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.0%
29/100 • Number of events 29 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.0%
17/100 • Number of events 17 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
17.0%
17/100 • Number of events 17 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.0%
13/100 • Number of events 13 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.0%
7/100 • Number of events 7 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.0%
6/100 • Number of events 6 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.0%
6/100 • Number of events 6 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Gastrointestinal disorders
Nausea
|
33.0%
33/100 • Number of events 33 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Gastrointestinal disorders
Vomiting
|
17.0%
17/100 • Number of events 17 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Gastrointestinal disorders
Constipation
|
10.0%
10/100 • Number of events 10 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
General disorders
Chest pain
|
12.0%
12/100 • Number of events 12 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
General disorders
Fatigue
|
10.0%
10/100 • Number of events 10 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
General disorders
Pyrexia
|
6.0%
6/100 • Number of events 6 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
General disorders
Respiratory complication associated with device
|
6.0%
6/100 • Number of events 6 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Vascular disorders
Hypertension
|
11.0%
11/100 • Number of events 11 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Vascular disorders
Hypotension
|
11.0%
11/100 • Number of events 11 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Cardiac disorders
Atrial fibrillation
|
8.0%
8/100 • Number of events 8 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Cardiac disorders
Tachycardia
|
5.0%
5/100 • Number of events 5 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Nervous system disorders
Dizziness
|
7.0%
7/100 • Number of events 7 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.0%
6/100 • Number of events 6 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Infections and infestations
Pneumonia
|
7.0%
7/100 • Number of events 7 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
5/100 • Number of events 5 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
5.0%
5/100 • Number of events 5 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
5/100 • Number of events 5 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
5/100 • Number of events 5 • AEs were collected through Day 28 (+/- 4 days) from OTL38 administration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60