Using pafolacianine for imaging during surgery for gastrointestinal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study evaluates the effectiveness of pafolacianine (CYTALUX™) in identifying cancerous lesions in patients with gastrointestinal cancers and peritoneal carcinomatosis during cytoreductive surgery. It is a single-arm, open-label study that aims to improve surgical outcomes by enhancing the visualization of tumors. Participants will receive the drug prior to surgery, and its impact on surgical results will be assessed. The study focuses on adult patients diagnosed with adenocarcinoma who are scheduled for surgery.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Maheswari Senthil, MD — Chao Family Comprehensive Cancer Center
• Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
• Email: ucstudy@uci.edu
• Phone: 1-877-827-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.