Peritoneal Carcinomatosis
Conditions
Brief summary
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.
Interventions
DRUGpegsitacianine
An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
Sponsors
OncoNano Medicine, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Imaging and biopsy confirmed metastatic disease of peritoneal origin
Exclusion criteria
* Known hypersensitivity or allergy to any component of pegsitacianine * Tumor locations the surgeon deems unfeasible to image intraoperatively * Excessive and/or generalized metastatic disease deemed inoperative by the surgeon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 day | 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. |
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 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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Fluorescence Imaging With Pegsitacianine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 59 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 2 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 | 35 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 50 |
| other Total, other adverse events | 17 / 50 |
| serious Total, serious adverse events | 17 / 50 |
Outcome results
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.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fluorescence Imaging With Pegsitacianine | 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
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: 164/241 specimens collected
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluorescence Imaging With Pegsitacianine | Negative Predictive Value of Pegsitacianine | .68 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: 282/409 specimens collected
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluorescence Imaging With Pegsitacianine | Positive Predictive Value of Pegsitacianine | .689 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: 282/359 specimens were collected
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluorescence Imaging With Pegsitacianine | Sensitivity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen | .786 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: 164/291 specimens collected
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluorescence Imaging With Pegsitacianine | Specificity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen | .564 ratio |