In this study, we aim to identify the diagnostic value of indocyanine green (ICG) fluorescence imaging for SLNBs via the mastectomy incision.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To assess the detection rate of the ICG method to identify the SLN via a
mastectomy incision.
Secondary outcome
- The detection rate of 99mTc.
- The difference in detection rate between ICG and 99mTc.
- The median number of SLN identified with ICG and the standard 99mTc.
- Percentage of SLNs that is fluorescent, but not positive for 99mTc.
- Percentage of SLNs that are not fluorescent but positive for 99mTc.
- The difference in pathology of the SLN found by ICG and 99mTc, including the
difference between micro- and macro metastases (Mic and Mac resp.) and isolated
tumor cells (ITCs).
- Detection time for the use of ICG to detect the SLN, defined as time between
skin incision and SLN resection in minutes
- Complications, including wound infection, bleeding and lymphedema, of the
combination of the ICG method and the standard 99mTc method to identify the SLN
in mastectomies.
- The number of serious adverse events from the combination of ICG and 99mTc.
Background summary
Identifying lymphatic metastases is an important prognostic factor in the
survival rate of breast cancer and the presence of lymphatic metastases carries
consequences for further treatment. Results of our non-inferiority study
(INFLUENCE study) and previous literature, led to the implementation of
ICG-guided SLNBs via axillary incision as standard of care at St. Antonius
Hospital and Isala Hospital (Zwolle). The applicability of ICG-fluorescence for
SNLBs using the mastectomy incision has not been described yet. Surgeons may
perform SLNBs using the same incision as the mastectomy, rather than using an
additional axillary incision. In such setting, extended operating distance and
visualization with an improper angle might introduce challenges to identify the
SLN by tracking lymphatic vessels into the axilla.
Study objective
In this study, we aim to identify the diagnostic value of indocyanine green
(ICG) fluorescence imaging for SLNBs via the mastectomy incision.
Study design
This is a multicentre, cross-sectional study identifying the diagnostic value
of indocyanine green (ICG) fluorescence imaging for SLN mapping via the
mastectomy incision (different surgical approach).
Intervention
All included patients will receive standard of care implying 99mTc injection
the day before surgery. Consequently, 5 mg (2 ml) ICG will be injected
periareolar after administration of general anaesthesia and before incision.
The lateral edge of the standard mastectomy incision will be used to explore
the axilla for ICG fluorescent lymph nodes to avoid a separate axillary
incision. Then the excised nodes are tested for 99mTc activity with the
standard gamma detecting probe as control. Lastly, the axilla will be explored
with the standard gamma-probe for residual lymph nodes, and by common sight and
palpation as a control.
Study burden and risks
Consenting patients will not need to do anything extra than the standard of
care outside signing the informed consent. Administration of ICG will be done
while under general anaesthesia, so patients will not experience extra
discomfort, neither do they need extra site visits as the follow-up will be
done during the standard follow-up appointment. ICG is safe to use: it is
nonionizing and knows little to no complications and adverse events.
Considering the cut-off of 2 additional nodes, the preferable topographic
location of these nodes and the clinical experience with additional lymph
node sampling, we expect no increase in risk of surgical morbidity. Patients
might benefit from the intervention as ICG can increase the identification rate
of the sentinel lymph node procedure and might even replace 99mTc for SLN
mapping. Thus, both risks and burden are minimal.
Soestwetering 1
Utrecht 3543 AZ
NL
Soestwetering 1
Utrecht 3543 AZ
NL
Listed location countries
Age
Inclusion criteria
- Clinically node-negative, DCIS, invasive T1- T3 breast cancer confirmed by
biopsy.
- Preoperative axillary ultrasound to confirm clinical node-negative status.
- Indication (or preference) for mastectomy and simultaneous SLN procedure.
- Written informed consent according to ICH/GCP and national regulations.
Exclusion criteria
- Patients < 18 years old
- SN-procedure via axillary incision
- Known allergy for indocyanine green (ICG), radioisotope technetium (99mTc),
intravenous contrast, or iodine
- Other concurrent solid tumor.
- Hyperthyroidism or thyroid cancer
- Palliative surgery for locally advanced breast cancer (cT4)
- Pregnancy or breast feeding
- Psychological, familial, sociological or geographical factors that could
potentially hamper compliance with the study protocol
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80591.100.22 |