Trial Outcomes & Findings for A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies (NCT NCT05048082)
NCT ID: NCT05048082
Last Updated: 2024-11-08
Results Overview
Discovery of a clinically significant event at the level of the patient. May include detection of primary tumors, discovery of occult disease, or tumor negative SOC biopsies.
COMPLETED
PHASE2
24 participants
1 day
2024-11-08
Participant Flow
Patients scheduled for surgical excision of pulmonary lesions were eligible for enrollment. The study was conducted at two large cancer surgical centers from from April 13, 2022 through August 31, 2022. Four patients withdrew consent prior to dosing.
Participant milestones
| Measure |
Fluorescence Imaging With Pegsitacianine
Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery.
pegsitacianine: An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
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|---|---|
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Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies
Baseline characteristics by cohort
| Measure |
Fluorescence Imaging With Pegsitacianine
n=20 Participants
Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery.
pegsitacianine: An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
|
|---|---|
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Age, Continuous
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63.9 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
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13 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Patients that received at least 75% of planned dose, had at least 1 image collected, and had disease present
Discovery of a clinically significant event at the level of the patient. May include detection of primary tumors, discovery of occult disease, or tumor negative SOC biopsies.
Outcome measures
| Measure |
Fluorescence Imaging With Pegsitacianine
n=16 Participants
Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery.
pegsitacianine: An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
|
|---|---|
|
Proportion of Patients Experiencing at Least One Clinically Significant Event (CSE)
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2 Participants
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SECONDARY outcome
Timeframe: 7 daysPopulation: non-lymph node tissue specimens from lung resection
\# of true positive specimens divided by the (#of true positive specimens + # of false negative specimens)
Outcome measures
| Measure |
Fluorescence Imaging With Pegsitacianine
n=22 tissue specimens
Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery.
pegsitacianine: An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
|
|---|---|
|
Sensitivity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen
|
.32 ratio
Interval 0.125 to 0.566
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SECONDARY outcome
Timeframe: 7 daysPopulation: non-lymph node lung tissue specimens
\# of True Negative Specimens divided by the (# of True Negative Specimens + # of False Positive Specimens)
Outcome measures
| Measure |
Fluorescence Imaging With Pegsitacianine
n=22 tissue specimens
Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery.
pegsitacianine: An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
|
|---|---|
|
Specificity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen
|
.33 ratio
Interval 0.008 to 0.708
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SECONDARY outcome
Timeframe: 7 daysPopulation: non-lymph node tissue specimens
\# of True negative specimens divided by the (# of true negative specimens + # of false negative specimens)
Outcome measures
| Measure |
Fluorescence Imaging With Pegsitacianine
n=22 tissue specimens
Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery.
pegsitacianine: An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
|
|---|---|
|
Negative Predictive Value of Pegsitacianine
|
.071 ratio
Interval 0.002 to 0.339
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SECONDARY outcome
Timeframe: 7 daysPopulation: non-lymph node lung tissue specimens
\# of true positive specimens divided by the (# of true positive + # of false positive specimens)
Outcome measures
| Measure |
Fluorescence Imaging With Pegsitacianine
n=22 tissue specimens
Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery.
pegsitacianine: An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
|
|---|---|
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Positive Predictive Value of Pegsitacianine
|
.75 ratio
Interval 0.349 to 0.968
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Adverse Events
Fluorescence Imaging With Pegsitacianine
Serious adverse events
| Measure |
Fluorescence Imaging With Pegsitacianine
n=20 participants at risk
Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery.
pegsitacianine: An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
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5.0%
1/20 • Number of events 1 • Adverse events were collected from time of infusion (24 hours prior to surgery) through 28 days post surgery.
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Respiratory, thoracic and mediastinal disorders
Subcutaneoius Emphysema
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from time of infusion (24 hours prior to surgery) through 28 days post surgery.
|
Other adverse events
| Measure |
Fluorescence Imaging With Pegsitacianine
n=20 participants at risk
Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery.
pegsitacianine: An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
|
|---|---|
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Injury, poisoning and procedural complications
Procedural Pain
|
80.0%
16/20 • Number of events 16 • Adverse events were collected from time of infusion (24 hours prior to surgery) through 28 days post surgery.
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Injury, poisoning and procedural complications
Infusion Related Reactions
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20.0%
4/20 • Number of events 4 • Adverse events were collected from time of infusion (24 hours prior to surgery) through 28 days post surgery.
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Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
50.0%
10/20 • Number of events 10 • Adverse events were collected from time of infusion (24 hours prior to surgery) through 28 days post surgery.
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Respiratory, thoracic and mediastinal disorders
Pulmonary Air Leakage
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10.0%
2/20 • Number of events 2 • Adverse events were collected from time of infusion (24 hours prior to surgery) through 28 days post surgery.
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Gastrointestinal disorders
Nausea
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10.0%
2/20 • Number of events 2 • Adverse events were collected from time of infusion (24 hours prior to surgery) through 28 days post surgery.
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Blood and lymphatic system disorders
Anaemia
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10.0%
2/20 • Number of events 2 • Adverse events were collected from time of infusion (24 hours prior to surgery) through 28 days post surgery.
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Renal and urinary disorders
Urinary Retention
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10.0%
2/20 • Number of events 2 • Adverse events were collected from time of infusion (24 hours prior to surgery) through 28 days post surgery.
|
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Cardiac disorders
Hypotension
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from time of infusion (24 hours prior to surgery) through 28 days post surgery.
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Additional Information
Vice President, Clinical Operations
OncoNano Medicine, Inc
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place