Using pafolacianine for imaging during surgery for gastrointestinal cancer
The Impact of Pafolacianine Injection for Intraoperative Imaging on Outcomes of Gastrointestinal Cancer Peritoneal Carcinomatosis - A Pilot Study
This study is testing if a special imaging drug called pafolacianine can help doctors find cancer spots better during surgery for adults with gastrointestinal cancer.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT06511037 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a primary diagnosis of gastrointestinal adenocarcinoma who are scheduled for cytoreductive surgery.
Not a fit: Patients with inoperable gastrointestinal cancer or those who have previously been exposed to pafolacianine will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and better identification of cancerous tissues during surgery.
How similar studies have performed: While this approach is innovative, similar studies using intraoperative imaging techniques have shown promise in enhancing surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Orange, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.