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Glowing dye could help doctors see hidden tumors

NCT ID NCT06034197

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 early study tested a special dye called VGT-309 that makes cancer cells glow during a colonoscopy. The goal was to see if it is safe and helps doctors find colorectal tumors more easily. The study was stopped early and included 9 adults with colorectal 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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

9 people

The number who actually took part.

Started

Feb 2024

Finished

Apr 2025

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. Adult patients with histologically confirmed distal colorectal adenocarcinoma of any stage. 2. Be willing and able to sign the informed consent and comply with study procedures. 3. Are scheduled to undergo a SOC colonoscopy for restaging following radiochemotherapy or are scheduled to receive a SOC colonoscopy in the OR prior to resection 4. Have acceptable kidney and liver functions at study entry as evidenced by: 1. ALT/AST \< 1.5 times the upper limit of normal, 2. Creatinine clearance (according to Cockcroft-Gault Equation) \> 50 mL/min 3. Total bilirubin \< 1.5 times the upper limit of normal 5. Have an ECOG score of 0-2. 6. Be at least 18 years of age. 7. Female participants must be of non-childbearing potential, or, if of childbearing potential be non-pregnant or lactating and agree to use highly effective contraception from screening through 30 days after probe infusion 8. Male participants, if not surgically sterilized, and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 30 days post-dose and agree not to donate semen during this waiting period. 9. Highly effective contraception involves the use of a condom for the male, plus one of the following for the female: 1. Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or 2. Intrauterine device or intrauterine hormone-releasing system. NOTE: Participants who abstain from heterosexual intercourse as their usual and preferred lifestyle, will not be required to use contraception as described above. They are required to maintain abstinence from screening through Day 30, AND Participants in a same sex relationship, must use a barrier form of contraception (e.g., condom, diaphragm) to protect against the transfer of the study drug in any bodily fluids. Exclusion Criteria: Inclusion Criteria: 1. Adult patients with histologically confirmed distal colorectal adenocarcinoma of any stage. 2. Be willing and able to sign the informed consent and comply with study procedures. 3. Are scheduled to undergo a SOC colonoscopy for restaging following radiochemotherapy or are scheduled to receive a SOC colonoscopy in the OR prior to resection 4. Have acceptable kidney and liver functions at study entry as evidenced by: 1. ALT/AST \< 1.5 times the upper limit of normal, 2. Creatinine clearance (according to Cockcroft-Gault Equation) \> 50 mL/min 3. Total bilirubin \< 1.5 times the upper limit of normal 5. Have an ECOG score of 0-2. 6. Be at least 18 years of age. 7. Female participants must be of non-childbearing potential, or, if of childbearing potential be non-pregnant or lactating and agree to use highly effective contraception from screening through 30 days after probe infusion 8. Male participants, if not surgically sterilized, and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 30 days post-dose and agree not to donate semen during this waiting period. 9. Highly effective contraception involves the use of a condom for the male, plus one of the following for the female: 1. Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or 2. Intrauterine device or intrauterine hormone-releasing system. NOTE: Participants who abstain from heterosexual intercourse as their usual and preferred lifestyle, will not be required to use contraception as described above. They are required to maintain abstinence from screening through Day 30, AND Participants in a same sex relationship, must use a barrier form of contraception (e.g., condom, diaphragm) to protect against the transfer of the study drug in any bodily fluids. Exclusion Criteria: 1. Pregnant or breastfeeding females 2. They have a known allergy or reaction to ICG, other radiographic contrast agents, or any component of VGT-309. 3. Have congenital long QT syndrome or QTcF \> 450ms (males) or \>470ms (females) by history or at Screening ECG. 4. They are prisoners, institutionalized individuals, or are unable to consent for themselves. 5. Class 2 or higher obesity, defined by BMI ≥ 35.0. 6. Have any other comorbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study.

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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.

Contacts and locations

Locations

  • Stanford University

    Palo Alto, California, 94304, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.