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Pilot Study of Pafolacianine for Gastrointestinal Cancer with Peritoneal Carcinomatosis

This study is testing a drug called pafolacianine (CYTALUX) to see if it can help surgeons find cancer during operations for gastrointestinal (GI) cancer that has spread to the lining of the abdomen (peritoneal carcinomatosis). Pafolacianine is given through an IV and helps cancer cells light up during surgery using a special camera. The study aims to see how well CYTALUX helps identify all cancerous areas and distinguish them from healthy tissue. Researchers will follow participants for one year to see the results of the surgery. You may be able to join if you are an adult with a primary GI cancer that is planned for surgery.

Study design
This is a pilot, single-arm, open-label study, meaning all 10 participants will receive the study drug and everyone involved will know what treatment is being given.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year after surgery to assess the study's main goals.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06511037

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
University of California, Irvine
~10 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cytoreduction (CC) Score
Measured over 1 year
+5 more outcomes measured

Conditions

Gastrointestinal Cancer
Peritoneal Carcinomatosis

Explore related trials

Malignant Digestive System NeoplasmPeritoneal Carcinomatosis

Where it's being run

1 sites across 1 states
California1

Study leadership

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

Who to contact

Chao Family Comprehensive Cancer Center University of California, Irvine
[email protected]
1-877-827-8839
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Cytoreduction (CC) Score1 year

    Describe the completeness of cytroreduction (cc) score with Cytoreductive surgery (CRS) with Cytalux injection.

  • Sensitivity-True Positive Rate (TPR)1 year

    Sensitivity, or the True Positive Rate (TPR), is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be gastrointestinal cancer (and folate receptor (FR) positive) by central pathology relative to the total number of lesions confirmed to be gastrointestinal cancer (FR+) by central pathology, that is proportion of cancerous lesions that are fluorescent light positive.

  • Specificity-True Negative Rate (TNR)1 year

    Specificity, or the True Negative Rate (TNR), is defined as the proportion of fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology, relative to the total number of lesions that are negative for gastrointestinal cancer (FR-) by central pathology-that is, the proportion of non-cancer lesions that are fluorescent light negative.

  • Positive Predictive Value (PPV)1 year

    Positive Predictive Value (PPV) is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and gastrointestinal cancer by central pathology relative to the total number of lesions removed that are fluorescent light positive-that is, the proportion of fluorescent light positive lesions that are cancerous.

  • Negative Predictive Value (NPV)1 year

    Negative Predictive Value (NPV) is defined as the proportion of fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology relative to the total number of lesions removed that are fluorescent light negative-that is, the proportion of fluorescent light negative lesions that are histologically negative for cancer.

  • Accuracy1 year

    Accuracy is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and gastrointestinal cancer by central pathology and the fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology relative to all lesions sampled.