PhI Pilot Study Pafolacianine Injec for Intraoperative Imag Gastrointestinal Can Peritoneal Carcinomatosis

Description

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.

Conditions

Gastrointestinal Cancer, Peritoneal Carcinomatosis

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Study Overview

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Study Details

Study 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.

A Pilot Study of Pafolacianine Injection for Intraoperative Imaging of Gastrointestinal Cancer Peritoneal Carcinomatosis

PhI Pilot Study Pafolacianine Injec for Intraoperative Imag Gastrointestinal Can Peritoneal Carcinomatosis

Condition
Gastrointestinal Cancer
Intervention / Treatment

-

Contacts and Locations

Orange

Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, California, United States, 92868

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Irvine,

Maheswari Senthil, MD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

Study Record Dates

2026-11-30