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Trial registered on ANZCTR


Registration number
ACTRN12609000653268
Ethics application status
Approved
Date submitted
30/07/2009
Date registered
4/08/2009
Date last updated
4/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Indocyanine Green (ICG) fluorescence guided sentinel node biopsy
for axillary nodal staging in breast cancer
Scientific title
Prospective Study for clinical approval of clinical feasibility of Indocyano Green for Fluorescene Detection of Sentinel Lymph Node and Real-time Lymphography in breast cancer patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 243403 0
Axillary metastasis 243404 0
Condition category
Condition code
Surgery 239711 239711 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sentinel lymph node (SLN) biopsy is an accepted method for staging of axillary lymph nodes in patients with early breast cancer. Patients with negative SLN can be spared axillary lamph node dissection (ALND) with a significantly lower incidence of numbness, pain, impaired mobility and delay to return to work compared to ALND.
SLN biopsy has been performed using different techniques, i.e. injection of blue dye, radioactive colloid or the combination of both. The average rate of SN identification using blue dye and radiocolloids is more than 95%, but results are ranging from 65% to 98%. However, there are concerns about sporadic limited availability and additional cost for radiocolloids that includes a lymphoscintigraphy for improved preoperative orientation for extra-axillary nodes and a handheld gamma probe. Furthermore, there are potential radiation hazards with the use of radiocolloids. There is recent evidence that Indocyanine green (ICG) could be a candidate for fluorescence guided SLN biopsy. ICG is a popular reagent that is clinically approved for the use of intravenous injection and has been applied in ocular arteriography and in the identification of gastric mucosal vessels. The reagent is a 776Da di-sulfonated molecule and shows a NIR fluorescence that has a moderate affinity binding site on human serum albumin. It rarely produces side effects and we observed no allergic reactions during the study.
The advantages of both radiocolloid and blue dye could be combined using fluorescent dye for sentinel node detection, namely transcutaneous real-time lymphography, lymphatic and SLN staining and identification of lymphatic abnormalities. This study was performed to investigate the clinical approval of ICG fluorescence imaging for SLN detection. Peritumoreous injection of approximately 10mg ICG (2ml with regard to 5mg/ml) was performed intraoperatively 10 min before transcutaneous real-time lymphography with laser induced fluorescene by a camcorder. After transcutaneous identification of a potential Sentinel Lymph Node (SLN), dissection was proceeded lasting about 5-15min to identify and prepare the SLN. Fluorescence was checked after removal of SLN, SLN was sent to pathology and procedure lasted overal time of about 20-30 min. SLN was performed one time for each patient.
Intervention code [1] 237042 0
Diagnosis / Prognosis
Comparator / control treatment
no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240480 0
Detection rate:
All patients with detected SLN divided by all included patients.

Sensitivity:
All patients with positive lymph nodes divided by all positive patients with regard to axillary lymph node dissection (ALND).
Timepoint [1] 240480 0
During operation and after histopathological examination.

instantaneous section was performed to decide wether to make immediate ALND or not.
After conventional and immunhistochemical histopathological examination positive patients without ALND were offered and recommended to to secondary ALND

Patients with undetected SLN were performed primary ALND.
Secondary outcome [1] 257021 0
Lymphonodal recurrence:
Each follow up consisted of clinical exam, laboratory, axillary and breast ultrasound, if necessary Magnetic Resonance Imaging (MRI)
Timepoint [1] 257021 0
Follow up 12, 48 and 60 month

Eligibility
Key inclusion criteria
Inclusion criteria were a histopathological approved diagnosis of breast cancer, tumour diameter <=3cm (preoperative T1/T2) and indication for mastectomy or breast conserving therapy without clinically positive lymph node status
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
operations and/or radiation of the breast, definite lymph node metastases diagnosed by palpation and ultrasound imaging and age <18y

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1925 0
Germany
State/province [1] 1925 0

Funding & Sponsors
Funding source category [1] 237416 0
University
Name [1] 237416 0
Charite Berlin
Address [1] 237416 0
Campus Buch
Robert Roessle Klinik
Klinik fuer CHirurgische Onkologie
Schwanebecker Ch 50
13125 Berlin
Germany
Country [1] 237416 0
Germany
Primary sponsor type
Hospital
Name
Charite Berlin
Address
Campus Buch
Robert Roessle Klinik
Klinik fuer CHirurgische Onkologie
Schwanebecker Ch 50
13125 Berlin
Germany
Country
Germany
Secondary sponsor category [1] 236913 0
None
Name [1] 236913 0
Address [1] 236913 0
Country [1] 236913 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239547 0
Ethics Committee of Charite University Berlin
Ethics committee address [1] 239547 0
Schumann Str 20/21
10115 Berlin
Ethics committee country [1] 239547 0
Germany
Date submitted for ethics approval [1] 239547 0
Approval date [1] 239547 0
01/04/2001
Ethics approval number [1] 239547 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29989 0
Address 29989 0
Country 29989 0
Phone 29989 0
Fax 29989 0
Email 29989 0
Contact person for public queries
Name 13236 0
Dr. Christoph Hirche
Address 13236 0
BG Unfallklinik
Department of Plastic Surgery
Ludwig Guttmann Str 13
67071 Ludwigshafen
Country 13236 0
Germany
Phone 13236 0
+49 176 64337616
Fax 13236 0
Email 13236 0
christoph@hirche.net
Contact person for scientific queries
Name 4164 0
Prof. Michael Hünerbein
Address 4164 0
HELIOS Hospital Berlin Buch
Surgical Department
Schwanebecker Ch. 50
13125 Berlin
Country 4164 0
Germany
Phone 4164 0
+49 30 9401 52700
Fax 4164 0
Email 4164 0
michael.huenerbein@helios-kliniken.de

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary