Gastrointestinal Cancer, Peritoneal Carcinomatosis
Conditions
Brief summary
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.
Interventions
DRUGPafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging
Given IV
Sponsors
University of California, Irvine
On Target Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients 18 years of age and older * Have a primary diagnosis of primary gastrointestinal cancer (of adenocarcinoma), planned for cytoreductive surgery * Female patients must have a negative serum pregnancy test at screening, followed by a negative urine pregnancy test on the day of scheduled study drug infusion, or day of surgery * Female patients of childbearing potential, or less than two (2) years postmenopausal, agree to use an acceptable form of contraception from time of signing informed consent until 30 days after study completion * Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by study restrictions
Exclusion criteria
* Previous exposure to CYTALUX™ (PAFOLACIANINE) * Patients with known gastrointestinal cancer with carcinomatosis determined pre-operatively to be inoperable * Any medical condition that in the opinion of the investigators could potential jeopardize the safety of the patient * History of anaphylactic reaction * History of allergy to any components of CYTALUX™ (PAFOLACIANINE), including folic acid * Pregnancy, or positive pregnancy test * Clinically significant abnormalities on ECG * Impaired renal function defined as eGFR \<50 mL/min/1.73m2 * Impaired liver function defined as values \>3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin * Received an investigational agent in another trial within 30 days prior to surgery * Known sensitivity to fluorescent light
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cytoreduction (CC) Score | 1 year | Describe the completeness of cytroreduction (cc) score with Cytoreductive surgery (CRS) with Cytalux injection. |
| Sensitivity-True Positive Rate (TPR) | 1 year | 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. |
| Specificity-True Negative Rate (TNR) | 1 year | 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. |
| Positive Predictive Value (PPV) | 1 year | 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. |
| Negative Predictive Value (NPV) | 1 year | 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. |
| Accuracy | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 30 days | 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 |
Countries
United States
Contacts
CONTACTChao Family Comprehensive Cancer Center University of California, Irvine
CONTACTUniversity of California Irvine Medical
PRINCIPAL_INVESTIGATORMaheswari Senthil, MD
Chao Family Comprehensive Cancer Center
Outcome results
None listed