SUSPENDED

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-09-27

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT06034197

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Stephan Rogalla, M.D., PhD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Stanford University

Palo Alto, California, 94304

United States

Collaborators and Investigators

Sponsor: Stephan Rogalla

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-27

Study Completion Date2026-12

Study Record Updates

Study Start Date2023-09-27

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Colorectal Cancer