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Peritoneal carcinomatosis (PC) results from the metastasis of a primary cancer of the peritoneum (e.g., appendiceal, ovarian, uterine, colorectal, and gastric cancers) that then disseminates throughout the abdominal cavity. Historically progression to PC was considered terminal and resulted in survival times on the scale of a few months with palliative care being the best option for patients. More recently, cytoreductive surgery (CS) has emerged as a means to prolong and improve patient lives with a median increase in survival of up to ~5 years. It has been reported that for every 10% increase in cytoreduction there is a 5.5% increase in median survival time. In addition to surgical tumor debulking within the peritoneal space, it has also been shown that coupling surgical intervention with hyperthermic intraperitoneal chemotherapy (HIPEC) can have an even greater impact on patient outcomes. Pegsitacianine, a micellar fluorescence agent, exploits the ubiquitous pH differences observed between cancerous and normal tissues. This in turn, provides a highly sensitive and specific fluorescence response after localizing within the tumor microenvironment, thus allowing the detection of primary tumors, their margins, metastatic disease, and tumor-containing lymph nodes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorescence imaging with pegsitacianine | Experimental | 1 mg/kg of pegsitacianine administered IV 24-72 hours prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegsitacianine | Drug | An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 7 days |
| Specificity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Wagner, MD | Allegheny Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States | ||
| The Ohio State University Wexner Medical Center / James Cancer Hospital |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects who received >75% of the intended dose of pegsitacianine, had a minimum of 1 image collected during their procedure, and had the opportunity for post-SOC evaluation of the thoracic cavity.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Posted | Count of Participants | Participants | 1 day |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | Complication related to surgery (Not related to pegsitacianine) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion Related Reactions | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment | mild to moderate and self-limiting |
Trial patients served as their own control since near infrared imaging was withheld until primary completion of surgery, which was defined by the surgeon.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Operations | OncoNano Medicine, Inc | (682) 285-1411 | trials@onconanomed.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 9, 2022 | Nov 6, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2023 | Nov 6, 2024 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
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A two group 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 surgery.
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|
# of True Negative Specimens divided by the (# of True Negative Specimens + # of False Positive Specimens) |
| 7 days |
| Negative Predictive Value of Pegsitacianine | # of True negative specimens divided by the (# of true negative specimens + # of false negative specimens) | 7 days |
| Positive Predictive Value of Pegsitacianine | # of true positive specimens divided by the (# of true positive + # of false positive specimens) | 7 days |
| Columbus |
| Ohio |
| 43201 |
| United States |
| Perelman School of Medicine, University of Pennsylvania | Philadelphia | Pennsylvania | 19146 | United States |
| AHN Cancer Institute, West Penn Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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) | 282/359 specimens were collected | Posted | Number | 95% Confidence Interval | ratio | 7 days | tissue specimens | tissue specimens |
|
|
|
| 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) | 164/291 specimens collected | Posted | Number | 95% Confidence Interval | ratio | 7 days | tissue specimens | tissue specimens |
|
|
|
| Secondary | Negative Predictive Value of Pegsitacianine | # of True negative specimens divided by the (# of true negative specimens + # of false negative specimens) | 164/241 specimens collected | Posted | Number | 95% Confidence Interval | ratio | 7 days | tissue specimens | tissue specimens |
|
|
|
| Secondary | Positive Predictive Value of Pegsitacianine | # of true positive specimens divided by the (# of true positive + # of false positive specimens) | 282/409 specimens collected | Posted | Number | 95% Confidence Interval | ratio | 7 days | tissue specimens | tissue specimens |
|
|
|
| 2 |
| 50 |
| 17 |
| 50 |
| 17 |
| 50 |
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| Device Dislocation | Product Issues | MedDRA (Unspecified) | Systematic Assessment | right ureteral stent migration occurred as a result of the surgical procedure |
|
| Abdominal Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Wound Abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | fatal |
|
| Gastric Perforation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Large Intestine Perforation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ileal Perforation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Intra-abdominal Haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Multiple Organ Dysfunction Syndrome | General disorders | MedDRA (Unspecified) | Systematic Assessment | fatal |
|
| Device Dislocation | Product Issues | MedDRA (Unspecified) | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
|
| Alanine Aminotransferase Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D010532 | Peritoneal Diseases |