Glow-in-the-Dark dye could help surgeons find hidden cancers
NCT ID NCT02584244
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2016
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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- Can a personalized menu keep cancer patients stronger through chemotherapy?