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Clinical Trials/EUCTR2019-003179-20-NL
EUCTR2019-003179-20-NL
Active, Not Recruiting
Phase 1

‘A pilot study to assess the safety and feasibility of fluorescent sentinel lymph node identification in colon carcinoma using Indocyanine green’ - FLUOR–ICG–SLN(pilot)

Meander Medical Centre0 sites10 target enrollmentMarch 23, 2020
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ConditionsColon carcinomaTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
DrugsVerdye

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Colon carcinoma
Sponsor
Meander Medical Centre
Enrollment
10
Status
Active, Not Recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 23, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Meander Medical Centre

Eligibility Criteria

Inclusion Criteria

  • •\- Oral and written informed consent (IC)
  • •\- Aged 18 years and older
  • •\- Pathologically confirmed and/or suspected colon carcinoma
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 5
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range 5

Exclusion Criteria

  • •\- Distant metastases
  • •\- Suspicion of T3\-T4 disease based on pre\-operative assessment.
  • •\- Metastatic or T4 disease discovered during intraoperative staging
  • •\- A tumour too large to pass endoscopically
  • •\- Pregnant patients
  • •\- Known allergy to any of the compound used for SLN identification (ICG, Iodine)
  • •\- Suspected or proven lymph node metastasis
  • •\- Previous colon surgery
  • •\- Contra\-indication for robotic surgery
  • •\- Ink marking close to the tumour

Outcomes

Primary Outcomes

Not specified

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