Glow-in-the-Dark dye helps surgeons find hidden cancer spots
NCT ID NCT03834272
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new imaging system that uses a fluorescent dye to help surgeons see cancer that has spread to the lining of the abdomen (peritoneum) during surgery. 18 adults with stomach, ovarian, or mesothelioma cancers that had spread to the abdomen were injected with the dye before surgery. A special camera then looked for glowing spots, which were checked against lab results to see if the system could accurately find cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LUM015 (a fluorescent dye injected before surgery)
- What this could lead to
- If successful, this imaging tool could help surgeons see tiny cancer spots in the abdomen that are hard to find with the naked eye, potentially leading to more complete removal of cancer.
- What could go wrong
- This is an early feasibility study with only 18 participants, so results may not apply to everyone. The dye and imaging system may not reliably detect all cancer spots, and there could be side effects from the dye.
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
-
18 people
The number who actually took part.
- Started
-
Mar 2019
- Finished
-
Aug 2025
- 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 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: * Subjects must have histologically or cytologically confirmed metastases to the peritoneum from gastrointestinal cancer, ovarian cancer or mesothelioma prior to surgery. * Subjects must be scheduled for surgical resection. * Age of 18 years or older. * Subjects must be able and willing to follow study procedures and instructions. * Subjects must have received and signed an informed consent form. * Subjects must be otherwise healthy except for the diagnosis of cancer, as per the criteria listed below. * Subjects must have normal organ and marrow function as defined as: * Leukocytes \> 3,000/mcL * Absolute neutrophil count \> 1,500/mcL * Platelets \> 100,000/mcL * total bilirubin within normal institutional limits * AST (SGOT)/ALT (SGPT) \< 2.5 X institutional upper limit of normal * Creatinine within normal institutional limits or creatinine clearance \> 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal. * Subjects with ECOG performance status of 0 or 1. Exclusion Criteria: * Subjects who are pregnant or nursing at the time of diagnosis. * Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception (hormonal or barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015. * Subjects who have taken an investigational drug within 30 days of enrollment. * Subjects who have not recovered from adverse events due to other pharmaceutical or diagnostic agents. * Subjects with uncontrolled hypertension defined as persistent systolic blood pressure \> 180 mm Hg, or diastolic blood pressure \> 100 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy. * History of allergic reaction attributed to drugs containing polyethylene glycol (PEG). * History of allergic reaction to any oral or intravenous contrast agents. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements. * HIV-positive individuals on combination antiretroviral therapy are ineligible. * Any subject for whom the investigator feels participation is not in the best interest of the subject.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Peritoneal metastases are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
Contacts and locations
Locations
-
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Chemotherapy sprayed directly into the abdomen: a new attack on stubborn cancers
- New radiation technique targets stomach and ovarian cancer spread without surgery
- New chemo spray aims to ease suffering from abdominal cancer spread
- New chemo spray shows promise for Hard-to-Treat abdominal cancers
- Could chemo around surgery beat cancer spread in the belly?
- PET scans may improve chemo decisions for abdominal cancer patients