Using a fluorescent probe to identify cancerous colorectal lesions during colonoscopy

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

This study is testing a special fluorescent probe to see if it can help doctors find cancerous spots in the colon more easily during colonoscopy.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT06034197 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and feasibility of VGT-309, a fluorescent probe, for real-time visualization of colorectal tumors during augmented colonoscopy using near-infrared fluorescence endoscopy. It will also evaluate over 50 biomarkers in biopsies through CODEX multi-plexing. The goal is to enhance the detection of cancerous lesions, potentially improving patient outcomes during colonoscopy procedures.

Who should consider this trial

Good fit: Ideal candidates include adult patients with confirmed distal colorectal adenocarcinoma who are scheduled for a standard colonoscopy for restaging or prior to resection.

Not a fit: Patients with non-colorectal cancers or those not scheduled for a colonoscopy will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate identification of colorectal tumors, improving treatment outcomes for patients.

How similar studies have performed: Other studies utilizing fluorescent probes for tumor visualization have shown promise, suggesting potential success for this novel approach.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

Inclusion 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.

Exclusion Criteria:

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. Class 2 or higher obesity, defined by BMI ≥ 35.0.
6. Have any other comorbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study.

Where this trial is running

Palo Alto, California

• Stanford University — Palo Alto, California, United States (Recruiting)

Study contacts

• Principal investigator: Stephan Rogalla, M.D., PhD — Stanford University
• Study coordinator: Joaquin Tabera

Conditions Colorectal Cancer