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

Description

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.

Conditions

Colorectal Cancer

Study Overview

Study Details

Study overview

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.

Pilot Open Label Study to Determine the Safety and Efficacy of Fluorescent Probe, VGT-309, to Identify Cancerous Colorectal Lesions During White-Light and Fluorescence Augmented Colonoscopy

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

Condition
Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • 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.
  • * 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. Have any other comorbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Stephan Rogalla, M.D., PhD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2025-03