NCT04642924

Brief Summary

Near-infrared fluorescence-guided oncologic surgery (EGOS) with the use of a tumor specific tracer (SGM-101) developed by Surgimab can provide valuable intra-operative information about tumor location and extensiveness, which can be difficult to detect with conventional visual and tactile feedback. Hence, this information could aid in intra-operative decision making and therewith foster complete resection margins and less extensive surgery. Subsequently, this may drastically improve patient care by improving oncologic outcome.

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
203

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2019

Typical duration for phase_2

Geographic Reach
1 country

4 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

October 22, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

November 16, 2020

Last Update Submit

November 23, 2020

Conditions

Rectal CancerRecurrent Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Resection status

    Pathologic resection status (R0 or R1)

    10 days post surgery

Study Arms (2)

Locally Advanced Rectal Cancer

EXPERIMENTAL

Patients included with locally advanced rectal cancer SGM-101 10mg, 3-5 days prior to surgery

Drug: SGM-101

Recurrent rectal cancer

EXPERIMENTAL

Patients included with (locally) recurrent rectal cancer SGM-101 10mg, 3-5 days prior to surgery

Drug: SGM-101

Interventions

SGM-101DRUG

Fluorescence-guided surgery

Locally Advanced Rectal CancerRecurrent rectal cancer

Eligibility Criteria

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

You may qualify if:

  • 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.
  • Patients should be scheduled and eligible for surgery because of a clinical diagnosis of T3 with a threatened CRM or T4 rectal cancer (locally advanced) or recurrent rectal cancer. (UICC. TNM classification of diseases for oncology. 3rd ed. Geneva: World Health Organization; 2000)
  • Patients should be capable and willing to give signed informed consent before study specific procedures.

You may not qualify if:

  • Other malignancies, either currently or in the past five years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma.
  • Patients with a history of, or recently diagnosed with, peritoneal metastases (even those diagnosed during surgery)
  • Patients with a recent history (within the last 3 years) of other distant metastases (even those diagnosed during surgery)
  • Patient with a history of a clinically significant allergy.
  • Patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential;
  • 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;
  • Any condition that the investigator considers to be potentially jeopardizing the patients' well-being or the study objectives.
  • Previous administration of SGM-101

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Amsterdam University Medical Center

Amsterdam, Netherlands

RECRUITING

Catharina Hospital Eindhoven

Eindhoven, Netherlands

RECRUITING

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

Haaglanden Medisch Centrum

The Hague, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Ruben Meijer

CONTACT

+31 71-52 98420r.p.j.meijer@lumc.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospectively inclusion treatment arm. Compared to historical cohort.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 24, 2020

Study Start

October 22, 2019

Primary Completion

October 1, 2021

Study Completion

October 1, 2023

Last Updated

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(4)