Fluorescent Probe VGT-309 to ID Cancerous Colorectal Lesions During Augmented Colonoscopy (NCT06034197) | Clinical Trial Compass
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 range18 Years
SexALL
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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
✓. Have an ECOG score of 0-2.
Exclusion 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: