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VGT-309 Imaging Technique for Colorectal Cancer

Phase < 1
Recruiting
Led By Stephan Rogalla, M.D., PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be at least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 days
Awards & highlights

Study Summary

This trial tests a new imaging technique to detect and measure colorectal tumors, plus measure biomarkers in tissue samples to assess tumor properties. #medtech

Who is the study for?
Adults with confirmed colorectal adenocarcinoma who are scheduled for a standard colonoscopy can join. They must have good liver and kidney function, not be pregnant or breastfeeding, agree to use effective contraception, and have an ECOG score of 0-2. Those allergic to ICG or VGT-309 components, with certain heart conditions, or unable to consent cannot participate.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of VGT-309 as a fluorescent probe during augmented colonoscopy for real-time visualization of colorectal tumors using NIR fluorescence endoscopy. It also examines over 50 biomarkers in biopsies.See study design
What are the potential side effects?
Potential side effects may include reactions related to the infusion of VGT-309 or allergies due to its components. The exact side effects are being studied as part of this trial's purpose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a colonoscopy in the operating room before surgery or for restaging after treatment.
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I am 18 years old or older.
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I am using a form of hormonal birth control.
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I am able to get out of my bed or chair and move around.
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I have been diagnosed with colorectal cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of VGT-309
Safety Profile of VGT309

Trial Design

1Treatment groups
Experimental Treatment
Group I: VGT-309Experimental Treatment1 Intervention
Subjects will receive an IV infusion of 0.32 mg/kg VGT-309 12 to 36 hours before a standard of care endoscopy procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VGT-309
2022
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,335 Total Patients Enrolled
Stanford's Innovative Medicines AcceleratorUNKNOWN
Stephan Rogalla, M.D., PhDPrincipal InvestigatorStanford University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the trial currently recruiting participants?

"As affirmed on clinicaltrials.gov, this particular trial is now closed to recruitment of patients; it was initially published on the 20th September 2021 and edited lastly as recent as 5th September 2021. Despite its closure, 1148 others are enrolling participants at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Fluorescent Probe VGT-309 to ID Cancerous Colorectal Lesions During Augmented Colonoscopy
2023. "Fluorescent Probe VGT-309 to ID Cancerous Colorectal Lesions During Augmented Colonoscopy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06034197.
~9 spots leftby Mar 2025
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