NCT04737213

Brief Summary

Near-infrared fluorescence-guided oncologic surgery (FGOS) with the use of a tumor specific tracer (SGM-101) developed by Surgimab can provide valuable intra-operative information about tumor location and extensiveness. SGM-101 already proven to be safe and valuable in colorectal cancer. This study aims to prove feasibility for colorectal lung metastases.

Trial Health

43
At Risk

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 colorectal-cancer

Timeline
Completed

Started Nov 2020

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

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

Study Start

First participant enrolled

November 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

January 27, 2021

Last Update Submit

February 1, 2021

Conditions

Colorectal CancerMetastatic Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • Ability of SGM-101 and a near-infrared camera system to detect colorectal lung metastases.

    Intraoperative imaging of colorectal lung metastases based on the tumor-to-background ratio

    peroperative

Study Arms (1)

SGM-101

EXPERIMENTAL

Patients included with colorectal lung metastases, SGM-101 7.5-12.5mg, 3-5 days prior to surgery

Drug: SGM-101

Interventions

SGM-101DRUG

Fluorescence guided surgery

SGM-101

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 lung metastasis of colorectal origin and scheduled for a resection.

You may not qualify if:

  • History of any anaphylactic reaction;
  • 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 (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate);
  • Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
  • Previous SGM-101 use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

Erasmus Medical Center

Rotterdam, Netherlands

NOT YET RECRUITING

Related Publications (1)

  • Meijer RPJ, Galema HA, Faber RA, Bijlstra OD, Maat APWM, Cailler F, Braun J, Keereweer S, Hilling DE, Burggraaf J, Vahrmeijer AL, Hutteman M; SGM-CLM study group. Intraoperative molecular imaging of colorectal lung metastases with SGM-101: a feasibility study. Eur J Nucl Med Mol Imaging. 2024 Aug;51(10):2970-2979. doi: 10.1007/s00259-023-06365-3. Epub 2023 Aug 8.

    PMID: 37552367DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Alexander Vahrmeijer

CONTACT

071 526 9111a.l.vahrmeijer@lumc.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective inclusion patients with colorectal lung metastases. Al injected with SGM-101.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2021

First Posted

February 3, 2021

Study Start

November 1, 2020

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

February 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)