TerminatedEarly Phase 1

Fluorescent Probe VGT-309 to ID Cancerous Colorectal Lesions During Augmented Colonoscopy

Stopped: The drug supply expired and the sponsor is unable to provide an updated supply.

United States9 participantsStarted 2024-02-07

Plain-language summary

The purpose of this study is to determine the safety and feasibility of VGT-309 for the visualization of colorectal tumors in real-time using near-infrared (NIR) fluorescence endoscopy. In addition, signatures of 50+ biomarkers will be evaluated in biopsies using CODEX multi-plexing.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult patients with histologically confirmed distal colorectal adenocarcinoma of any stage.
. Be willing and able to sign the informed consent and comply with study procedures.
. 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
. Have acceptable kidney and liver functions at study entry as evidenced by:
. ALT/AST \< 1.5 times the upper limit of normal,
. Creatinine clearance (according to Cockcroft-Gault Equation) \> 50 mL/min
. Total bilirubin \< 1.5 times the upper limit of normal

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety Profile of VGT309

Timeframe: 18 days

Feasibility of VGT-309

Timeframe: 18 days

Trial details

NCT IDNCT06034197

SponsorStephan Rogalla

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-04

View on ClinicalTrials.gov More Colorectal Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult patients with histologically confirmed distal colorectal adenocarcinoma of any stage.
. Be willing and able to sign the informed consent and comply with study procedures.
. 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
. Have acceptable kidney and liver functions at study entry as evidenced by:
. ALT/AST \< 1.5 times the upper limit of normal,
. Creatinine clearance (according to Cockcroft-Gault Equation) \> 50 mL/min
. Total bilirubin \< 1.5 times the upper limit of normal

Fluorescent Probe VGT-309 to ID Cancerous Colorectal Lesions During Augmented Colonoscopy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Fluorescent Probe VGT-309 to ID Cancerous Colorectal Lesions During Augmented Colonoscopy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria