EUCTR2009-011079-57-NL
Active, not recruiting
Not Applicable
Evaluation of Indocyanine Green (ICG) enhanced Near-InfraRed Fluorescence (NIRF) Imaging for Intra-Operative Sentinel Lymph Node (SLN) detection in Breast Surgery. - ICG enhanced SLNB
ConditionsWomen above the age of 21 with core biopsy or cytology proven breast cancer stage I and II, eligible for lumpectomy and sentinel lymph node procedureMedDRA version: 9.1Level: LLTClassification code 10006194Term: Breast cancer NOS stage IMedDRA version: 9.1Level: LLTClassification code 10006195Term: Breast cancer NOS stage II
DrugsICG-PULSION
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Women above the age of 21 with core biopsy or cytology proven breast cancer stage I and II, eligible for lumpectomy and sentinel lymph node procedure
- Sponsor
- niversity Medical Center Groningen
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women above 21 years of age with stage I\-II breast cancer diagnosed preoperatively by core biopsy or cytology and who have given informed consent according to the rules of the hospital. Patient is undergoing sentinel lymph node mapping for staging and treatment of their disease.
- •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
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. Refusal of the patient to be included in the study.
- •2\. Pregnant or breast\-feeding.
- •3\. History of iodine allergy or anaphylactic reactions to insect bites or medication.
- •4\. Presence or history of hyperthyroidism.
- •5\. Recent surgery on the armpit.
- •6\. Significant renal (serum creatinine \= 400 µmol/L) dysfunction.
- •7\. Cardiac and/or pulmonary disease (ASA III\-IV).
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 3
Evaluation of Indocyanine Green (ICG) enhanced Near-InfraRed Fluorescence (NIRF) Imaging for Intra-Operative Sentinel Lymph Node (SLN) detection in Breast Surgery.breast cancersentinel lymph node procedure1000629110043413NL-OMON33334niversitair Medisch Centrum Groningen150
Recruiting
Phase 2
Evaluation of Indocyanine fluorescense in gastroenterological surgeryJPRN-jRCTs041180149yama Ichiro300
Recruiting
Phase 2
Role of Sentinel Lymph Node Evaluation Using Indocyanine Green in the Management of Early Stage Gynecological CancersCTRI/2023/03/051086Indian Council of Medical Research, New Delhi
Not yet recruiting
Phase 4
The use of Indocyanine green fluorescence with near-infrared imaging to intra-operatively assess tissue perfusion in gastrointestinal surgery.gastro-intestinal cancer and obesity1001799110017998NL-OMON43568Catharina-ziekenhuis740
Recruiting
Not Applicable
Exploratory clinical study on Indocyanine Green (ICG) navigated lymph node dissection in robot-assisted radical prostatectomyProstate cancerJPRN-UMIN000024989ational Cancer Center Hospital:Tsukiji Campus70