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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR1700 |
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Date of registration:
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09/03/2009 |
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Primary sponsor: |
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Public title:
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Evaluatie van een nieuwe optische beeldvormingstechniek voor de detectie van de schildwachtklier bij patienten met borstkanker.
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Scientific title:
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Evaluation of Indocyanine Green (ICG) enhanced Near-InfraRed Fluorescence (NIRF) Imaging for Intra-Operative Sentinel Lymph Node (SLN) detection in Breast-conserving Surgery. - NIRF SLNB |
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Date of first enrolment:
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1/5/2009 |
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Target sample size:
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200 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1700 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: None; Control: Not applicable; Group: [default]; Type: Single arm
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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G.M.
Dam, van |
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Address:
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University Medical Center Groningen
Department of Surgery / BioOptical Imaging Center Groningen
, Hanzeplein 1
9700 RB
Groningen
The Netherlands |
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Telephone:
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+31 (0)50 3612283 |
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Email:
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g.m.van.dam@chir.umcg.nl |
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Affiliation:
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Name:
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G.M.
Dam, van |
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Address:
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University Medical Center Groningen
Department of Surgery / BioOptical Imaging Center Groningen
, Hanzeplein 1
9700 RB
Groningen
The Netherlands |
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Telephone:
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+31 (0)50 3612283 |
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Email:
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g.m.van.dam@chir.umcg.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patient with operable stage I-II breast cancer diagnosed preoperatively by core biopsy or cytology (cT1-2N0).
Exclusion criteria: 1. Refusal of the patient to be included in the study;
2. Pregnant or breast-feeding;
3. Significant renal dysfunction (serum creatinine above 400 micromol/L);
4. cardiac and/or pulmonary disease (ASA III-IV);
5. History of iodine allergy or anaphylactic reactions to insect bites or medication;
6. Presence or history of hyperthyroidism;
7. Recent surgery on the armpit.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Breast cancer
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Intervention(s)
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Patients with operable breast cancer stage I-II undergoing a lumpectomy, combined with a sentinel lymph node procedure, will receive prior to a lumpectomy and SLN procedure an intratumoral injection with indocyanin green (ICG).
During the operative procedure NIRF imaging for detection of the SLN (i.e. ICG accumulation) will take place.
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Primary Outcome(s)
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Whether ICG enhanced NIRF imaging is able to detect sentinel lymph nodes as good as or better than the standard technique (technetium-99 labelled colloid and Patent Blue) during breast surgery in 97%± 2% of the cases.
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Secondary Outcome(s)
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The number of lymph nodes detected by ICG enhanced NIRF imaging during breast surgery.
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Secondary ID(s)
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BICG26UMCG-NIRF
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Source(s) of Monetary Support
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University Medical Center Utrecht (UMCU), Department of Surgery
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