NCT04755920

Brief Summary

This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
2.9 years until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

2.1 years

First QC Date

January 27, 2021

Last Update Submit

May 7, 2024

Conditions

Rectal NeoplasmsRectum CancerColorectal NeoplasmsBrain MetastasesBrain NeoplasmsBrain DiseasesBrain CancerBrain TumorIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal CancerGastrointestinal DiseaseIntestinal Disease

Outcome Measures

Primary Outcomes (1)

  • To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases.

    * Concordance between the fluorescent signal and the tumor status (incl. degree of CEA-expression) of resected tissue; * Concordance between the fluorescent signal and the resection margin with the use of neuronavigation

    Intraoperative

Study Arms (1)

Patients with colorectal brain metastases

EXPERIMENTAL

10 mg SGM-101, administration 3 to 5 days prior to surgery.

Drug: SGM-101

Interventions

SGM-101DRUG

Fluorescence-guided surgery

Patients with colorectal brain metastases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent prior to any study-mandated procedure;
  • Patients aged over 18 years old;
  • All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment.
  • Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
  • Diagnosed with brain metastasis of colorectal origin and scheduled for a resection.

You may not qualify if:

  • History of any anaphylactic reaction;
  • Previous use of SGM-101;
  • Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma;
  • Laboratory abnormalities defined as:
  • Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;
  • Total bilirubin above 2 times the ULN or;
  • Serum creatinine above 1.5 times the ULN or;
  • Platelet count below 100 x 109/L or;
  • Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
  • 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;
  • Patients pregnant or breastfeeding;
  • Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

RECRUITING

Medical Center Haaglanden

The Hague, 2512 VA, Netherlands

RECRUITING

MeSH Terms

Conditions

Rectal NeoplasmsColorectal NeoplasmsBrain NeoplasmsBrain DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesIntestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesRectal DiseasesColonic DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Mats Warmerdam, MD

CONTACT

+31 71 5265 401m.i.warmerdam@lumc.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oncologic Surgeon - Hepatobiliary and Colorectal

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 16, 2021

Study Start

January 1, 2024

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)