Trial Outcomes & Findings for A Study to Evaluate ONM100, an Intraoperative Fluor Imaging Agent for the Detection of Peri Mets (NCT NCT04950166)
NCT ID: NCT04950166
Last Updated: 2024-11-08
Results Overview
Percentage of patients that had at least one additional lesion detected under pegsitacianine guidance following standard of care cytoreductive surgery that would have been left behind had imaging not been performed and was confirmed to be positive for disease by pathological evaluation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
1 day
Results posted on
2024-11-08
Participant Flow
Patients scheduled for cytoreductive surgery of the peritoneum were eligible for enrollment into the study at major oncologic surgical centers. The trial opened to enrollment in September 2021 with the first patient consenting Nov 30, 2021.
Participant milestones
| Measure |
Fluorescence Imaging With Pegsitacianine
1 mg/kg of pegsitacianine administered IV 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
|
51
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Fluorescence Imaging With Pegsitacianine
1 mg/kg of pegsitacianine administered IV 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
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study to Evaluate ONM100, an Intraoperative Fluor Imaging Agent for the Detection of Peri Mets
Baseline characteristics by cohort
| Measure |
Fluorescence Imaging With Pegsitacianine
n=40 Participants
1 mg/kg of pegsitacianine administered IV 24-72 hours prior to surgery.
pegsitacianine: An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=99 Participants
|
|
Age, Continuous
|
59 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 dayPercentage of patients that had at least one additional lesion detected under pegsitacianine guidance following standard of care cytoreductive surgery that would have been left behind had imaging not been performed and was confirmed to be positive for disease by pathological evaluation.
Outcome measures
| Measure |
Fluorescence Imaging With Pegsitacianine
n=40 Participants
1 mg/kg of pegsitacianine administered IV 24-72 hours prior to surgery.
pegsitacianine: An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
|
|---|---|
|
Percentage of Patients That Had at Least One Additional Lesion Detected Under Pegsitacianine Guidance Following CRS That Was Confirmed as Positive for Disease by Pathological Evaluation
|
20 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 282/359 specimens were collected
\# of true positive specimens divided by the (#of true positive specimens + # of false negative specimens)
Outcome measures
| Measure |
Fluorescence Imaging With Pegsitacianine
n=359 tissue specimens
1 mg/kg of pegsitacianine administered IV 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
|
.786 ratio
Interval 0.7 to 0.866
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 164/291 specimens collected
\# of True Negative Specimens divided by the (# of True Negative Specimens + # of False Positive Specimens)
Outcome measures
| Measure |
Fluorescence Imaging With Pegsitacianine
n=291 tissue specimens
1 mg/kg of pegsitacianine administered IV 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
|
.564 ratio
Interval 0.481 to 0.655
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 164/241 specimens collected
\# of True negative specimens divided by the (# of true negative specimens + # of false negative specimens)
Outcome measures
| Measure |
Fluorescence Imaging With Pegsitacianine
n=241 tissue specimens
1 mg/kg of pegsitacianine administered IV 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
|
.68 ratio
Interval 0.566 to 0.797
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 282/409 specimens collected
\# of true positive specimens divided by the (# of true positive + # of false positive specimens)
Outcome measures
| Measure |
Fluorescence Imaging With Pegsitacianine
n=409 tissue specimens
1 mg/kg of pegsitacianine administered IV 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
|
.689 ratio
Interval 0.595 to 0.78
|
Adverse Events
Fluorescence Imaging With Pegsitacianine
Serious events: 17 serious events
Other events: 17 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Fluorescence Imaging With Pegsitacianine
n=50 participants at risk
1 mg/kg of pegsitacianine administered IV 24-72 hours prior to surgery.
pegsitacianine: An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
|
|---|---|
|
Infections and infestations
Sepsis
|
6.0%
3/50 • Number of events 3 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Product Issues
Device Dislocation
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Infections and infestations
Abdominal Infection
|
4.0%
2/50 • Number of events 2 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Infections and infestations
Wound Abscess
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
4.0%
2/50 • Number of events 2 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Gastrointestinal disorders
Gastric Perforation
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Gastrointestinal disorders
Ileal Perforation
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Gastrointestinal disorders
Intra-abdominal Haemorrhage
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Cardiac disorders
Myocardial Infarction
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Cardiac disorders
Cardiac Arrest
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
2/50 • Number of events 2 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Vascular disorders
Embolism
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Vascular disorders
Shock haemorrhagic
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.0%
1/50 • Number of events 1 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
Other adverse events
| Measure |
Fluorescence Imaging With Pegsitacianine
n=50 participants at risk
1 mg/kg of pegsitacianine administered IV 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
Infusion Related Reactions
|
28.0%
14/50 • Number of events 14 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Investigations
Alanine Aminotransferase Increased
|
4.0%
2/50 • Number of events 2 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Investigations
Aspartate Aminotransferase Increased
|
4.0%
2/50 • Number of events 2 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
4.0%
2/50 • Number of events 2 • Adverse events were collected for ~2 months. Starting from time of single dose infusion (24-72 hours prior to surgery) through the 28 day visit following hospital discharge.
|
Additional Information
Vice President, Clinical Operations
OncoNano Medicine, Inc
Phone: (682) 285-1411
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place