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Clinical Trials/EUCTR2019-003828-21-NL
EUCTR2019-003828-21-NL
Active, not recruiting
Phase 1

Identification of sentinel lymph nodes in breast cancer patients through non-invasively and percutaneously fluorescent imaging using indocyanine green - INFLUENCE

St Antonius Hospital0 sites100 target enrollmentJanuary 21, 2020
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ConditionsAxillar staging in breast cancer patientsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
DrugsIndocyanine Green (VERDYE)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Axillar staging in breast cancer patients
Sponsor
St Antonius Hospital
Enrollment
100
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 21, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Clinically node\-negative, invasive early T1 or T2 breast cancer confirmed by biopsy.
  • •\- Preoperative axillary ultrasound to confirm clinical node\-negative status.
  • •\- Indication for lumpectomy and SLN procedure.
  • •\- Written informed consent according to ICH/GCP and national regulations.
  • •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 100
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 100

Exclusion Criteria

  • •\-Patients \< 18 years old.
  • •\-Mastectomy.
  • •\-Known allergy for indocyanine green (ICG) or radioisotope technetium (99mTc) or intravenous contrast, iodine, shellfish.
  • •\-Other concurrent solid tumor.
  • •\-Hyperthyroidism or thyroid cancer.
  • •\-Palliative surgery for locally advanced breast cancer (cT4\).
  • •\-Pregnancy or breast feeding.
  • •\-Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol.

Outcomes

Primary Outcomes

Not specified

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