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VGT-309 Imaging Agent for Lung Cancer Detection (VISUALIZE Trial)

Phase 2

Recruiting

Research Sponsored by Vergent Bioscience, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an ECOG score of 0-2

Meet all standard of care surgical and general anesthesia requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during surgery and up to one month post-surgery

Awards & highlights

VISUALIZE Trial Summary

This trial will study the safety and effectiveness of an imaging agent to help detect and diagnose lung cancer during surgery. About 100 people will take part.

Who is the study for?

This trial is for adults with suspected or confirmed lung cancer who are fit for surgery and have not been in another clinical trial in the last month. They must be able to consent, have good kidney and liver function, an ECOG score of 0-2, meet surgical requirements, and follow contraception guidelines.Check my eligibility

What is being tested?

The study tests VGT-309's safety and effectiveness. It's a fluorescent imaging agent used during lung cancer surgery to help identify tumors. The open-label Phase 2 trial will enroll around 100 subjects to ensure at least 86 evaluable participants.See study design

What are the potential side effects?

Potential side effects may include allergic reactions related to the imaging agent VGT-309 or its components. Since it involves surgery, standard surgical risks also apply.

VISUALIZE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to get out of my bed or chair and move around.

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I meet all requirements for surgery and anesthesia.

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I am 18 years old or older.

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I have a lung mass that could be cancer or has spread from another cancer.

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I am scheduled for surgery to remove a lung nodule or mass.

VISUALIZE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during surgery and up to one month post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during surgery and up to one month post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and during surgery and up to one month post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Measurements taken under SOC surgical procedures and under NIR imaging

VISUALIZE Trial Design

1Treatment groups

Experimental Treatment

Group I: 0.32 mg/kg VGT-309Experimental Treatment1 Intervention

0.32 mg/kg VGT-309 given over 15-20 minutes by syringe pump

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VGT-309

2022

Completed Phase 2

~40

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vergent Bioscience, Inc.Lead Sponsor

1 Previous Clinical Trials

40 Total Patients Enrolled

Curtis Scribner, MDStudy DirectorVergent Bioscience

2 Previous Clinical Trials

43 Total Patients Enrolled

Frequently Asked Questions

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

How many volunteers are currently participating in this clinical experiment?

"Affirmative, the information available on clinicaltrials.gov affirms that this trial is actively recruiting individuals. It was first posted online on October 5th 2023 and edited as recently as November 17th 2023. The research requires 100 participants to be enrolled from a single location."

Answered by AI

Have any government regulatory bodies sanctioned the use of 0.32 mg/kg VGT-309?

"With 0.32 mg/kg of VGT-309, our team at Power rate its safety to be a 2 on the 1 - 3 scale; this is due to the Phase 2 nature of the trial which implies that there is some evidence for safety but none for efficacy."

Answered by AI

Are participants still being sought for this research endeavor?

"Affirmative. Clinicaltrials.gov verifies that this medical trial, which was initially published on October 5th 2023, is recruiting participants. It seeks to enlist 100 patients between a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung.

2023. "Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06145048.

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