Pafolacianine Imaging for Gastrointestinal Cancer

Overseen By Laura Sarmiento

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Folate supplements

Disqualifiers: Anaphylaxis, Allergy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to identify certain gastrointestinal cancers using a special imaging dye called CYTALUX™ (pafolacianine), which illuminates cancer cells. The goal is to determine if this method can improve the detection of gastric, esophageal, and appendiceal adenocarcinomas during surgery. Potential participants include individuals who suspect they have these cancers and are planning surgery. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

Will I have to stop taking my current medications?

The trial requires you to stop taking folate, folic acid, or folate-containing supplements within 48 hours before receiving the study drug. Other medications are not mentioned, so it's best to discuss with the trial team.

What is the safety track record for CYTALUX™ (pafolacianine)?

A previous study tested the safety of CYTALUX™ (pafolacianine) in patients with ovarian cancer. The results showed it was generally well-tolerated. Common side effects included nausea and vomiting, but these were not severe for most people. Since the FDA has already approved CYTALUX for use in ovarian cancer surgery, there is some confidence in its safety for finding cancer lesions. This trial aims to determine if it can help detect adenocarcinoma, a type of cancer, in the digestive system. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for gastrointestinal cancer that focus on surgery, chemotherapy, or radiation, CYTALUX™ (pafolacianine) offers a unique imaging approach. This treatment uses a special dye that highlights cancer cells, making them easier to identify during surgery. Researchers are excited because this method enhances the surgeon's ability to accurately locate and remove cancerous tissue, potentially improving surgical outcomes and reducing the chances of cancer recurrence.

What evidence suggests that CYTALUX™ (pafolacianine) is effective for detecting gastrointestinal cancer?

Research shows that CYTALUX™ (pafolacianine), which participants in this trial will receive, helps doctors identify cancerous tissues during surgery. This treatment uses a special dye that illuminates under a specific light, making cancer cells more visible. Studies have found that this method works well for various cancers, such as ovarian cancer, by attaching to cancer cells and highlighting them. This imaging technique aids surgeons in locating and removing tumors more effectively, reducing the chance of leaving any cancerous tissue behind. Since CYTALUX™ is already approved for other uses, strong evidence supports its safety and effectiveness in identifying cancer. ^{3 5 6 7 8}

Who Is on the Research Team?

Miguel Burch, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

Adults with suspected or confirmed gastroesophageal adenocarcinoma needing surgery, or those with appendiceal cancer and possible spread to the lining of the abdomen. Participants must be willing to avoid folate supplements before receiving CYTALUX™ and consent to study procedures.

Inclusion Criteria

Willingness of research participant to give written informed consent

I need surgery for a stomach or esophagus tumor, or to check for abdominal cancer spread.

I am 18 years old or older.

Exclusion Criteria

Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule

Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject

History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CYTALUX™ (pafolacianine) injection intravenously for imaging during planned surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• CYTALUX™ (pafolacianine)

Trial Overview

The trial is testing CYTALUX™ (pafolacianine) injection used during surgery for gastrointestinal cancers. It's an open-label study assessing how well this drug helps in visualizing cancer with near-infrared fluorescent imaging.

How Is the Trial Designed?

Group I: CYTALUX™ (pafolacianine) Experimental Treatment 1 Intervention

Enrolled subjects will be dosed with 0.025 mg/kg CYTALUX™ (pafolacianine) injection intravenously, with the hour-long infusion completing from 1 hour to up to 24 hours prior to imaging for the planned surgery.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

On Target Laboratories, LLC

Industry Sponsor

Trials

8

Recruited

470+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07124351

Study Details | NCT07124351 | Intraoperative Imaging of ...

This is an open-label study in adults to determine feasibility of using CYTALUX™ (pafolacianine) injection with near-infrared (NIR) fluorescent imaging for ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12035792/

Real‑world application of Cytalux for targeted imaging ...

Both our and previous data suggest that Cytalux has a high affinity for tumor cells in the majority of EOC patients, but its uptake should ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07039526

Study Details | NCT07039526 | Single Dose Investigator ...

Can CYTALUX™ (pafolacianine) injection used with near-infrared (NIR) fluorescent imaging improve the detection of malignant tissue in subjects undergoing ...

4.

withpower.com

withpower.com/trial/phase-1-gastrointestinal-neoplasms-7-2025-7bae7

Pafolacianine Imaging for Gastrointestinal Cancer

This is an open-label study in adults to determine feasibility of using CYTALUX™ (pafolacianine) injection with near-infrared (NIR) fluorescent imaging for ...

5.

cancer.gov

cancer.gov/clinicaltrials/NCI-2024-06351

Pafolacianine Sodium for the Intraoperative Imaging of ...

This phase I trial studies whether pafolacianine sodium (cytalux) works better than the standard approach at identifying cancer lesions that should be removed ...

6.

cytaluxhcp.com

cytaluxhcp.com/important-safety-information/

CYTALUX Important Safety Information

CYTALUX® is an FDA approved optical imaging agent indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian ...

7.

cytalux.com

cytalux.com/important-safety-information/

CYTALUX Important Safety Information

Important safety information on the use of CYTALUX to help surgeons visualize ovarian cancer lesions during surgery.

8.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2022/214907s002lbl.pdf

Cytalux - accessdata.fda.gov

The safety of CYTALUX was evaluated in four open label clinical studies, two studies (N = 44 and N = 150) in patients with ovarian cancer and two studies (N ...