Fluorescence-guided Resection Of Colorectal Liver Metastases Using SGM-101 and Indocyanine GREEN

NCT05965817 | Recruiting Phase 2

• 1 other identifier: P23
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This will be the first trial testing the feasibility of working simultaneously with the two fluorescent dyes ICG and SGM-101 in 10 patients with colorectal metastases.

Conditions

Colorectal Cancer; Liver Metastasis Colon Cancer; Image

Outcome Measures

Primary Outcomes (1)

• To assess the feasibility of simultaneous use of ICG and SGM-101 for intraoperative imaging of colorectal liver metastases.

  It is deemed feasible when it meets all of the following criteria: 1. A positive score on practical workability measured with survey A 'practical workability during surgery' 2. A positive score on the patient's experience measured with survey B 'patient experience'. 3. SGM-101: at least 80% sensitivity, measured as follows: * For capsular lesions, that are visible in white light are counted positive if TBR ≥ 1.5 in vivo. * For subcapsular lesions that are not visible in white light will be counted as positive if: A: TBR ≥ 1.5 in vivo, OR B: TBR ≥ 1.5 ex vivo on whole specimen or on bread loafs 4. No cross-interference of fluorescent signal of both dyes within the two different excitation and emission channels. Feasibility is reached when a positive result on all four items is scored.

  1.5 years

Study Arms (1)

Patients with colorectal liver metastases receiving SGM-101 and ICG

EXPERIMENTAL

In total 10 patients will be included who are scheduled for resection of colorectal liver metastases and receive SGM-101 and ICG

Drug: SGM-101 op top of ICG

Interventions

SGM-101 op top of ICG DRUG

SGM-101 op top of ICG

Patients with colorectal liver metastases receiving SGM-101 and ICG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Diagnosed with liver metastases of colorectal origin for which surgical resection is proposed and meet at least one of the following criteria:
• Scheduled for surgical resection of \>3 CRLM or;
• completed neo-adjuvant therapy, of which the last course was completed within 3 months before surgery or;
• Scheduled for surgery because of a locally recurrent liver metastasis.
• ≥18 years old.
• Willing and capable to give informed consent before study specific procedures

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Patients with contraindications for SGM-101
• History of any anaphylactic shock;
• Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate);
• Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections;
• Previous administration of SGM-101
• Patients with contraindications for Indocyanine green:
• Allergy for shells and/or clamps
• Hyperthyroidism
• Known allergy for ICG
• Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, 2333ZA, Netherlands

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Mats Warmerdam, Msc

CONTACT

0715298420; m.i.warmerdam@lumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, principle investigator

Model Details: In total 10 patients will be included who are scheduled for resection of colorectal liver metastases and meet at least one of the following criteria: 1. Scheduled for resection of \>3 CRLM or, 2. Completed neo-adjuvant chemotherapy, of which the last course was completed within 3 months before surgery or, 3. Scheduled for surgery because of a locally recurrent liver metastasis.

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: December 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)