This study aims at evaluating whether indocyanin green (ICG) enhanced intra-operative near-infrared fluorescence (NIRF) imaging is as good as or even better than the standard technique (technetium-99 labeled colloid and Patent Blue) in detecting…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
The number of lymph nodes detected by ICG enhanced NIRF imaging during breast
surgery.
Background summary
In breast cancer patients undergoing breast-conserving surgery, tumour excision
(lumpectomy) is often combined with a so-called sentinel lymph node procedure.
Within the field of surgical oncology, the surgeon-oncologist lacks real-time
intraoperative feedback on surgical margin status and locoregional metastasis.
As a consequence, both over- and undertreatment common during breast-conserving
surgery. Overtreatment is present when the surgeon excises an abundant amount
of healthy breast tissue, which inevitably leads to dissapointing cosmetic
results. Undertreatment, on the contrary, is defined as the presence of postive
surgical margins after the excision of the primary tumour. Positive surgical
margins necessitate re-excission or additional radiation to the breast and may
result in increased psychological distress for the patient, physical
comorbidity, logistical problems and cost/technical problems. Furthermore, the
surgeon lacks trusthworthy information on the presence and location of affected
locoregional lymph nodes. This could lead to e.g. unnessacery lymph node
dissections in breast cancer patients. In up to 70% of all patients in who the
sentinel lymph node is affected, the backlaying lymph node bassin is free of
metastasis. However, in the current standard of treatment, these unaffected
lymph nodes are disected as well, which could lead to unnessacary mobidity
including lymphoedema, disruption of sensibility or motor functions and an
increased risk for infection of the affected arm.
In close collaboration with the Technical University of Munich, we developed a
state-of-the-art camera system for intra-operative fluorescence imaging in
vivo. Recently, this camara system, enhanced with the fluorescent dye
'indocyanin green' (ICG), was tested clinically in 10 stadium I-II breast
cancer patients (METc 2008.298). By utilizing this system, we were able to
detect subcutane lymph tracks and lymph nodes in real-time. As the feasibility
study in these 10 patients has been succesful, we now will move on towards
evaluating the value of near-infrared fluorescence (NIRF) optical imaging
during the sentinel lymph node procedure in breast cancer patients.
Indocyanin green (ICG) has been extensively tested in human beings and is
registered for several medical applications. The use of ICG enhanced NIRF
optical imaging might improve the detection of the sentinel lymph node and
related lymph nodes, which could decrease both the over- and undertreatment of
breast cancer patients with a T1-2N0 status. Ultimately, this might result in
decreased re-excision rates, psychological distress, co-morbidity and general
health costs.
In the current non-inferiority study, the value of ICG enhanced NIRF optical
imaging for the detection of the sentinel lymph node will be evaluated with
respect to the current standard of treatment (radiocolloid + patent blue). It
is expected that ICG enhanced NIRF optical imaging will be as least as or even
more succesful in detecting the sentinel lymph node than the current standard.
Study objective
This study aims at evaluating whether indocyanin green (ICG) enhanced
intra-operative near-infrared fluorescence (NIRF) imaging is as good as or even
better than the standard technique (technetium-99 labeled colloid and Patent
Blue) in detecting sentinel lymph nodes in breast-conserving surgery.
Study design
Interventional study: Treatment, Non-randomized, Open Label, Controlled, Single
Group Assignment, Active-control Non-inferiority design.
Study burden and risks
Anaphylactic and allergic reactions have been reported in patients with or
without a history of iodine allergy. The incidence of an anaphylactic reaction
is lower than 1/10.000 cases after intravenous administration. A green
discoloration of the skin at the side of injection has been described. In all
cases the discoloration disappeared within two weeks. No potential benefits,
beside the feasibility of Indocyanine Green as a fluorescent contract agent,
will be expected.
The burden associated with participation consists of an additional injection of
indocyanin green (ICG) intratumoural besides patent blue during anaesthesia for
the detection of the SLN. Additionally, there is a chance of elongation of the
operative procedure by using a NIRF imaging device for up to 30 minutes.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Women above the age of 21 who have biopsy-proven breast cancer stage I-II, and who are undergoing sentinel lymph node mapping for staging and treatment of their disease.
Exclusion criteria
Pregnant women, hyperthyroidism, significant renal (serum creatinin >= 400 µmol/L), cardiac or pulmonary disease (ASA III-IV), history of iodine allergy or analfylactic reaction to insect bites or medication.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-011079-57-NL |
| CCMO | NL27380.042.09 |