Glow-in-the-Dark dye could help surgeons find hidden cancers

NCT ID NCT02584244

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special dye and imaging system to help surgeons see colorectal, pancreatic, esophageal, and stomach cancers during surgery. About 66 adults scheduled for cancer surgery will receive the dye, and the imaging system will check if it lights up cancer tissue. The goal is to see if this tool is safe and can help remove all cancer.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 66 people

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

Started

Aug 2016

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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. Subjects must have histologically or cytologically confirmed esophageal, colorectal or pancreatic adenocarcinoma (inclusive of high grade dysplasia and cystic neoplasms) on a biopsy prior to surgery and must be scheduled for surgical resection, inclusive of endoscopic mucosal resection, of the primary tumor. Subjects at any cancer stage will be enrolled. 2. Subjects may have previously received pre-operative radiation therapy and neoadjuvant chemotherapy. 3. Age of 18 years or older. 4. Subjects must be able and willing to follow study procedures and instructions. 5. Subjects must have received and signed an informed consent form. 6. Subjects must be sufficiently healthy to undergo surgery or an endoscopic procedure. 7. Subjects must have normal organ and marrow function as defined below: * Leukocytes \>/= 3,000/mcL * Absolute neutrophil count \>/= 1,500/mcL * Platelets \>/= 100,000/mcL * total bilirubin within normal institutional limits (except in cases of malignant biliary obstruction) * AST (SGOT)/ALT (SGPT) \</= 2.5 X institutional upper limit of normal (\</= 5 x ULN in cases of malignant biliary obstruction) * Creatinine within normal institutional limits or creatinine clearance \>/= 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal. 8. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) starting the day entering the study, and for 60 days after injection of the imaging agent. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 9. Subjects with ECOG performance status of 0 or 1. Exclusion Criteria: 1. Subjects who have taken an investigational drug within 30 days of enrollment. 2. Subjects with QTc interval \> 480ms. 3. Subjects who have not recovered from adverse events due to pharmaceutical or diagnostic agents administered more than 4 weeks earlier. 4. Subjects with uncontrolled hypertension defined as persistent systolic blood pressure \> 180 mm Hg, or diastolic blood pressure \> 110 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy 5. History of allergic reaction attributed to drugs containing polyethylene glycol (PEG) 6. History of allergic reaction to oral or intravenous contrast agents. 7. Pregnant women or lactating women 8. Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception upon entering the study. 9. HIV-positive individuals on combination antiretroviral therapy. 10. Any subject for whom the investigator feels participation is not in the best interest of the subject.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

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