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| ID | Type | Description | Link |
|---|---|---|---|
| UCI 23-184 | Other Identifier | UCI CFCCC |
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| Name | Class |
|---|---|
| On Target Laboratories | UNKNOWN |
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This is a pilot, single-arm, open label study to evaluate the ability of CYTALUX™ (pafolacianine) to help identify cancerous lesions in subjects with gastrointestinal cancers and peritoneal carcinomatosis during cytoreductive surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pafolacianine (CYTALUX) | Experimental | All subjects will receive one single intravenous infusion of 0.025 mg/kg of pafolacianine (CYTALUX) injection prior to anticipated intraoperative imaging planned for cytoreductive surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Cytoreduction (CC) Score | Describe the completeness of cytroreduction (cc) score with Cytoreductive surgery (CRS) with Cytalux injection. | 1 year |
| Sensitivity-True Positive Rate (TPR) | Sensitivity, or the True Positive Rate (TPR), is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be gastrointestinal cancer (and folate receptor (FR) positive) by central pathology relative to the total number of lesions confirmed to be gastrointestinal cancer (FR+) by central pathology, that is proportion of cancerous lesions that are fluorescent light positive. | 1 year |
| Specificity-True Negative Rate (TNR) | Specificity, or the True Negative Rate (TNR), is defined as the proportion of fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology, relative to the total number of lesions that are negative for gastrointestinal cancer (FR-) by central pathology-that is, the proportion of non-cancer lesions that are fluorescent light negative. | 1 year |
| Positive Predictive Value (PPV) | Positive Predictive Value (PPV) is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and gastrointestinal cancer by central pathology relative to the total number of lesions removed that are fluorescent light positive-that is, the proportion of fluorescent light positive lesions that are cancerous. | 1 year |
| Negative Predictive Value (NPV) | Negative Predictive Value (NPV) is defined as the proportion of fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology relative to the total number of lesions removed that are fluorescent light negative-that is, the proportion of fluorescent light negative lesions that are histologically negative for cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence rates of all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) from the time of CYTALUX (PAFOLACIANINE) injection administration through the conclusion of study participation | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center University of California, Irvine | Contact | 1-877-827-8839 | ucstudy@uci.edu | |
| University of California Irvine Medical | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Maheswari Senthil, MD | Chao Family Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center, University of California, Irvine | Recruiting | Orange | California | 92868 | United States |
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| 1 year |
| Accuracy | Accuracy is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and gastrointestinal cancer by central pathology and the fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology relative to all lesions sampled. | 1 year |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D000008 | Abdominal Neoplasms |
| D010532 | Peritoneal Diseases |
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| ID | Term |
|---|---|
| C000720187 | Pafolacianine |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
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