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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

1 day

Results posted on

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

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).
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

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).
Age, Continuous
63.9 years
STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
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
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
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
20 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: 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

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)
2 Participants

SECONDARY outcome

Timeframe: 7 days

Population: 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

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

SECONDARY outcome

Timeframe: 7 days

Population: non-lymph node lung tissue specimens

\# of True Negative Specimens divided by the (# of True Negative Specimens + # of False Positive Specimens)

Outcome measures

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

SECONDARY outcome

Timeframe: 7 days

Population: non-lymph node tissue specimens

\# of True negative specimens divided by the (# of true negative specimens + # of false negative specimens)

Outcome measures

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

SECONDARY outcome

Timeframe: 7 days

Population: non-lymph node lung tissue specimens

\# of true positive specimens divided by the (# of true positive + # of false positive specimens)

Outcome measures

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).
Positive Predictive Value of Pegsitacianine
.75 ratio
Interval 0.349 to 0.968

Adverse Events

Fluorescence Imaging With Pegsitacianine

Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths

Serious adverse events

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
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.
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

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).
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.
Injury, poisoning and procedural complications
Infusion Related Reactions
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.
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.
Respiratory, thoracic and mediastinal disorders
Pulmonary Air Leakage
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.
Gastrointestinal disorders
Nausea
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.
Blood and lymphatic system disorders
Anaemia
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.
Renal and urinary disorders
Urinary Retention
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.
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.

Additional Information

Vice President, Clinical Operations

OncoNano Medicine, Inc

Phone: (682) 285-1411

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place