PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis

Early Phase 1RecruitingNCT06511037

University of California, Irvine10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastrointestinal Cancer Peritoneal Carcinomatosis

Interventions

Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imagingDRUG

Given IV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States

RECRUITING

Outcomes

Primary Outcomes

Cytoreduction (CC) Score

Describe the completeness of cytroreduction (cc) score with Cytoreductive surgery (CRS) with Cytalux injection.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839 ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Data from ClinicalTrials.gov

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PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts

Secondary Outcomes