Status:
RECRUITING
Fluorescent Probe VGT-309 to ID Cancerous Colorectal Lesions During Augmented Colonoscopy
Lead Sponsor:
Stephan Rogalla
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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, s...
Eligibility Criteria
Inclusion
- 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.
- Be at least 18 years of age.
- 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
- 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.
- Highly effective contraception involves the use of a condom for the male, plus one of the following for the female:
- Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or
- 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
- 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.
- Be at least 18 years of age.
- 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
- 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.
- Highly effective contraception involves the use of a condom for the male, plus one of the following for the female:
- Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or
- 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.
Key Trial Info
Start Date :
September 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06034197
Start Date
September 27 2023
End Date
March 1 2026
Last Update
May 6 2025
Active Locations (1)
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1
Stanford University
Palo Alto, California, United States, 94304