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Glow-in-the-Dark dye helps surgeons spot hidden cancer

NCT ID NCT07039526

Diagnosis Sponsor: John Waters Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a dye called CYTALUX (pafolacianine) that attaches to cancer cells and glows under a special camera during surgery. About 50 adults with certain cancers (like esophageal, pancreatic, or gynecologic) will get the dye before surgery. The goal is to see if the glowing helps surgeons find and remove tumors that are not visible under normal light. Participation lasts about 2 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pafolacianine (CYTALUX)
What this could lead to
If it works, this could help surgeons see and remove more cancer during surgery, potentially improving outcomes.
What could go wrong
This is a small early-phase study (50 people) testing an already-approved drug for a new use. It may not work for all cancer types, and the dye could cause allergic reactions or false positives.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and Female patients 18 years of age and older 2. Have a primary diagnosis, or a high clinical suspicion, of gastrointestinal, fore gut, pancreatic, hepatobiliary, esophageal malignancies and gyn malignancies planned for HIPEC/debulking, warranting surgery. 3. Are scheduled to undergo surgical intervention for tumor resection or diagnostic laparoscopy for assessment of disease burden. 4. Willingness to stop the use of folate, folic acid, or folate-containing supplements within 48 hours before administration of Cytalux 5. Willingness of research participant or legal guardian/representative to give written informed consent. Exclusion Criteria: 1. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject 2. History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation. 3. History of allergy to any of the components of CYTALUX™ (pafolacianine) injection 4. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule

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Conditions

The condition(s) this trial relates to.

digestive system cancer digestive system neoplasm esophageal cancer Esophageal Neoplasms female reproductive organ cancer hepatobiliary neoplasm malignant pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal cancer Gastrointestinal cancers Gynecologic cancers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clemments University Hospital

    RECRUITING

    Dallas, Texas, 75235, United States

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