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Evaluatie van een nieuwe optische beeldvormingstechniek voor de detectie van de schildwachtklier bij patienten met borstkanker.

Evaluation of Indocyanine Green (ICG) enhanced Near-InfraRed Fluorescence (NIRF) Imaging for Intra-Operative Sentinel Lymph Node (SLN) detection in Breast-conserving Surgery.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27252
Enrollment
200
Registered
2009-03-09
Start date
2009-05-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer, sentinel lymph node procedure, image-guided surgery, schildwacht klier procedure, borstkanker

Interventions

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 w

Sponsors

University Medical Center Groningen, Department of Surgery
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient with operable stage I-II breast cancer diagnosed preoperatively by core biopsy or cytology (cT1-2N0).

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
The number of lymph nodes detected by ICG enhanced NIRF imaging during breast surgery.

Contacts

Public ContactG.M. Dam, van

University Medical Center Groningen Department of Surgery / BioOptical Imaging Center Groningen

g.m.van.dam@chir.umcg.nl+31 (0)50 3612283

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)