RECRUITING

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

Conditions

Gastrointestinal Cancer Peritoneal Carcinomatosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-11-13

Study Completion:2026-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06511037

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839

ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Principal Investigator

Maheswari Senthil, MD

PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Study Locations (Sites)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868

United States

Collaborators and Investigators

Sponsor: University of California, Irvine

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-13

Study Completion Date2026-11-30

Study Record Updates

Study Start Date2024-11-13

Study Completion Date2026-11-30

Terms related to this study

Additional Relevant MeSH Terms

Gastrointestinal Cancer
Peritoneal Carcinomatosis