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Cancer Imaging Agent

Pafolacianine Imaging for Gastrointestinal Cancer

Phase < 1

Waitlist Available

Led By Maheswari Senthil, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Have a primary diagnosis of primary gastrointestinal cancer (of adenocarcinoma), planned for cytoreductive surgery

Must not have

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

Impaired renal function defined as eGFR <50 mL/min/1.73m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if CYTALUX™ can help surgeons identify cancerous lesions in patients with certain types of cancers during surgery.

Who is the study for?

This trial is for individuals with gastrointestinal cancers and peritoneal carcinomatosis. Participants should be candidates for cytoreductive surgery, which aims to remove visible tumors from the abdomen.

What is being tested?

The study tests CYTALUX (pafolacianine) used during surgery to see if it can better highlight cancerous tissues using a special camera that detects its fluorescent glow under near-infrared light.

What are the potential side effects?

Potential side effects of CYTALUX may include allergic reactions, changes in liver enzymes, nausea, or other infusion-related reactions. The imaging process itself is unlikely to cause side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman and have had negative pregnancy tests before receiving study treatment or surgery.

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My cancer originates in the gastrointestinal tract and I am scheduled for surgery to remove it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver tests are more than three times the normal limit.

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My kidney function is reduced with an eGFR below 50.

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My gastrointestinal cancer with carcinomatosis is considered inoperable.

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I have been treated with CYTALUX before.

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I am allergic to CYTALUX or its components, including folic acid.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accuracy

Negative Predictive Value (NPV)

Positive Predictive Value (PPV)

+2 more

Secondary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pafolacianine (CYTALUX)Experimental Treatment1 Intervention

All subjects will receive one single intravenous infusion of 0.025 mg/kg of pafolacianine (CYTALUX) injection prior to anticipated intraoperative imaging planned for cytoreductive surgery.

0 / 7Eligibility criteria met