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SGM-101 for Colorectal Cancer

Phase 3

Recruiting

Led By Alex L. Vahrmeijer,, MD, PhD

Research Sponsored by Surgimab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients scheduled for curative colorectal cancer surgery of primary cT4 colon cancer or primary cT3/4 rectal cancer, recurrent colorectal cancer, or peritoneal metastasized colorectal cancer

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of surgery, up to 9 weeks.

Awards & highlights

Study Summary

This trial will compare the use of SGM-101, an intraoperative imaging agent, to standard "white light" visualization during colorectal cancer surgery.

Who is the study for?

This trial is for adults with colorectal cancer who are scheduled for surgery. It's open to those with primary advanced or recurrent tumors, including peritoneal metastases. Women must be non-childbearing or agree to contraception. Excluded are individuals with certain blood abnormalities, liver and kidney issues, active infections, HIV/HBV/HCV, other recent cancers except some skin/cervical cancers.Check my eligibility

What is being tested?

SGM-101, a fluorescent imaging agent used during surgery for colorectal cancer is being tested against the standard white light method. The goal is to see if SGM-101 helps surgeons better identify and remove cancerous tissue.See study design

What are the potential side effects?

Potential side effects of SGM-101 aren't detailed here but may include reactions at the injection site or allergic responses due to its nature as an imaging agent used intraoperatively.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for surgery aimed at curing advanced or recurrent colorectal cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of surgery, up to 9 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of surgery, up to 9 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of surgery, up to 9 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Surgical resection histopathology.

Trial Design

2Treatment groups

Active Control

Group I: TreatmentActive Control1 Intervention

Patients will receive a single dose of the study drug, SGM-101, and subsequently undergo surgical resections under both "standard "white light" conditions and then NIR.

Group II: No TreatmentActive Control1 Intervention

Patients will not be administered the study drug, SGM-101, and will undergo surgical resections under standard :white light" conditions only.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

SurgimabLead Sponsor

5 Previous Clinical Trials

318 Total Patients Enrolled

Alex L. Vahrmeijer,, MD, PhDPrincipal InvestigatorLeiden University Medical Center, Leiden, The Netherlands

Media Library

Treatment Clinical Trial Eligibility Overview. Trial Name: NCT03659448 — Phase 3

Colorectal Cancer Research Study Groups: Treatment, No Treatment

Colorectal Cancer Clinical Trial 2023: Treatment Highlights & Side Effects. Trial Name: NCT03659448 — Phase 3

Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT03659448 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being accepted into the research at this time?

"That is correct, the listed clinical trial on clinicaltrials.gov is still recruiting patients. This study was posted on June 17th, 2019 and was last updated May 4th, 2022. They are looking for 300 total enrollees at 5 different locations."

Answered by AI

Are there any harmful side effects to this medication?

"The safety of this treatment, as scored by our team at Power, falls on the third tier of our 1-to-3 scale. This is due to it being a Phase 3 trial, where there not only exists some data affirming its efficacy, but also multiple rounds of data which support its safety."

Answered by AI

At how many facilities is this clinical trial being conducted?

"To make participation more convenient for patients, this trial is being conducted at 5 sites. 3 of these are in Weston, Philadelphia and Boston with the other 2 locations yet to be determined."

Answered by AI

How many people are included in this research project?

"Surgimab, the sponsor of this clinical trial, needs to recruit 300 patients that meet the study's inclusion criteria from various locations. Two such sites include Cleveland Clinic Florida and Perelman Center for Advanced Medicine."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer

2019. "Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03659448.

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