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

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Jul 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new injectable drug called CYTALUX™ (pafolacianine) to see if it can help doctors find cancerous spots during surgery for patients with gastrointestinal cancers, specifically those whose cancer has spread to the lining of the abdomen, known as peritoneal carcinomatosis. The trial is currently recruiting participants who are 18 years or older and are scheduled to have cytoreductive surgery, which is a procedure aimed at removing as much of the cancer as possible.

To be eligible for this study, participants must have a confirmed diagnosis of gastrointestinal cancer and meet certain health criteria, such as not having any serious allergies or medical conditions that could make surgery unsafe. Women must also have a negative pregnancy test and agree to use contraception if they can become pregnant. Those who join the study will receive the CYTALUX™ injection before their surgery and will help researchers understand how well this drug works in identifying cancerous tissues. It's important to know that this trial is in the early phase, which means it's one of the first steps in testing this treatment's effectiveness and safety.

Gender

ALL

Eligibility criteria

• 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