Lung Cancer
Conditions
Brief summary
This Phase 2 study is an open-label, single-arm trial where each patient is his/her own intrapatient control. All patients will receive a single dose of pegsitacianine prior to standard of care surgery.
Detailed description
This single-arm trial will enroll patients with biopsy confirmed or a high clinical suspicion of a lung malignancy based on MRI, CT and/or PET imaging. A total of up to 40 patients will be enrolled in this trial. The sponsor reserves the right to perform an interim analysis following early enrollment (i.e., n ≤ 10 subjects) to determine the feasibility and benefit of pegsitacianine as an adjunct to standard of care surgical resection of lung malignancies. The surgeon will begin by attempting to perform their SOC tumor resection. If the tumor is unable to be located under standard white light conditions, an appropriate FDA-cleared near-infrared imaging device may be used to aid in the location of the primary tumor. Localization of the primary tumor, when unable to be located using white light imaging, in conjunction with pathology confirmed presence of disease will be considered a clinically significant event. Following any standard of care procedures conducted under white light only, the near infrared camera will be used to evaluate areas of residual fluorescence that may be resected if suscpicious for metastatic spread or residual margins. The fluorescence status of each specimen will then be correlated to the final pathology for each, and performance metrics of pegsitacianine will be tabulated.
Interventions
DRUGpegsitacianine
An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
PROCEDURETumor resection surgery
Standard of care surgical removal of cancerous lung lesion
Sponsors
OncoNano Medicine, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
An interventional, open-label, single arm trial where each patient is his/her own intrapatient control. All patients will receive a single dose of pegsitacianine administered intravenously prior to standard of care (SOC) surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biopsy confirmed diagnosis, or a high clinical suspicion of a lung malignancy based on MRI, CT and/or PET imaging
Exclusion criteria
* Known hypersensitivity or allergy to indocyanine green (ICG), polymethylmethacrylate (PMMA; found in dental and bone cements) or polyethylene glycol (PEG) * Tumor locations the surgeon deems unfeasible to image intraoperatively * Excessive and/or generalized disease deemed inoperable by the surgeon * Life expectancy less than 12 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Experiencing at Least One Clinically Significant Event (CSE) | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen | 7 days | \# of true positive specimens divided by the (#of true positive specimens + # of false negative specimens) |
| Specificity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen | 7 days | \# of True Negative Specimens divided by the (# of True Negative Specimens + # of False Positive Specimens) |
| Negative Predictive Value of Pegsitacianine | 7 days | \# of True negative specimens divided by the (# of true negative specimens + # of false negative specimens) |
| Positive Predictive Value of Pegsitacianine | 7 days | \# of true positive specimens divided by the (# of true positive + # of false positive specimens) |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Fluorescence Imaging With Pegsitacianine |
|---|---|
| Age, Continuous | 63.9 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 19 / 20 |
| serious Total, serious adverse events | 2 / 20 |
Outcome results
Primary
Proportion of Patients Experiencing at Least One Clinically Significant Event (CSE)
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.
Time frame: 1 day
Population: Patients that received at least 75% of planned dose, had at least 1 image collected, and had disease present
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluorescence Imaging With Pegsitacianine | Proportion of Patients Experiencing at Least One Clinically Significant Event (CSE) | 2 Participants |
Secondary
Negative Predictive Value of Pegsitacianine
\# of True negative specimens divided by the (# of true negative specimens + # of false negative specimens)
Time frame: 7 days
Population: non-lymph node tissue specimens
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluorescence Imaging With Pegsitacianine | Negative Predictive Value of Pegsitacianine | .071 ratio |
Secondary
Positive Predictive Value of Pegsitacianine
\# of true positive specimens divided by the (# of true positive + # of false positive specimens)
Time frame: 7 days
Population: non-lymph node lung tissue specimens
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluorescence Imaging With Pegsitacianine | Positive Predictive Value of Pegsitacianine | .75 ratio |
Secondary
Sensitivity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen
\# of true positive specimens divided by the (#of true positive specimens + # of false negative specimens)
Time frame: 7 days
Population: non-lymph node tissue specimens from lung resection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluorescence Imaging With Pegsitacianine | Sensitivity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen | .32 ratio |
Secondary
Specificity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen
\# of True Negative Specimens divided by the (# of True Negative Specimens + # of False Positive Specimens)
Time frame: 7 days
Population: non-lymph node lung tissue specimens
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluorescence Imaging With Pegsitacianine | Specificity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen | .33 ratio |