In this non-inferiority study, we aim to identify the diagnostic value of indocyanine green (ICG) fluorescence imaging for SLN mapping versus the standard-of-care 99mTc in the SLN procedure for breast cancer patients.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Identification rate of positive SLNs percutaneously by the fluorescent signal
of ICG .
Secondary outcome
- Identification rate of positive SLNs percutaneously by 99mTc.
- Number of lymph nodes identified with ICG and standard 99mTc.
- Sensitivity: percentage of patients in whom fluorescent lymph nodes were
identified of the total patients with identified sentinel lymph nodes by the
standard 99mTc.
- False positive rates of ICG and 99mTc.
- False negative rates of ICG and 99mTc.
- Pathology of SLN found by ICG and 99mTc including micro- and macro metastasis
and isolated tumor cells (ITCs).
- Intraoperative visualization of the SLN with the camera by ICG and 99mTc
before skin incision.
- Transit time and detection time.
- Complications from ICG and 99mTc, including lymph edema, (wound)infection,
bleeding.
- Number of adverse events from 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. The golden standard for obtaining the SLN
in patients with breast cancer is radio guided surgery with radioisotope
technetium (99mTc), sometimes combined with blue dye. However, both 99mTc and
blue dye may present adverse effects and logistical challenges. A promising
alternative method is the use of fluorescence imaging using indocyanine green
(ICG). It is non-ionizing, easy to apply, patient- and surgeon friendly, safe,
easy to obtain and cost-effective.
Study objective
In this non-inferiority study, we aim to identify the diagnostic value of
indocyanine green (ICG) fluorescence imaging for SLN mapping versus the
standard-of-care 99mTc in the SLN procedure for breast cancer patients.
Study design
This is a single institution, single arm diagnostic efficacy trial identifying
the diagnostic value of indocyanine green (ICG) fluorescence imaging for SLN
mapping versus the standard-of-care radioisotope technetium (99mTc) in the SLN
procedure for breast cancer.
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. A
surgically considered incision in the axilla is made while taking into account
the marker of the ICG hotspots. 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.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
- Clinically node-negative, invasive early T1 or T2 breast cancer confirmed by
biopsy.
- Preoperative axillary ultrasound to confirm clinical node-negative status.
- Indication for lumpectomy and SLN procedure.
- Written informed consent according to ICH/GCP and national regulations.
Exclusion criteria
- Patients < 18 years old.
- Mastectomy.
- Known allergy for indocyanine green (ICG) or radioisotope technetium (99mTc)
or intravenous contrast, iodine, shellfish.
- 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
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
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-003828-21-NL |
| CCMO | NL71617.100.19 |