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

University of California Irvine (UCI)

Status and phase: Enrolling; Early Phase 1

Conditions: Gastrointestinal Cancer; Peritoneal Carcinomatosis

Treatments: Drug: Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT06511037

4951

UCI 23-184 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Pafolacianine (CYTALUX)

Experimental group

Description:

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.

Treatment:

Drug: Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging