The objective of this study is to evaluate the (nationwide and international) implementation of ICG-fluorescence for SN-procedures for patients with breast cancer.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the effectiveness of Indocyanine Green (ICG) for sentinel lymph
biopsies in breast cancer patients.
Secondary outcome
Secondary Objectives:
To assess:
- The median number of SLN identified
- Percentage of SLNs that has 99mTc uptake/ is fluorescent
- The pathology of SLNs found by localization method, including micro- and
macro metastases and isolated tumor cells (ITCs)
- The detection time, defined as time between skin incision and SLN resection
in minutes
- Duration of the SN-procedure
- Duration of the total surgical procedure
- Complications, including seroma, wound infection and bleeding
- The number of serious adverse events
- Duration of the total procedure
- Locoregional recurrence after 1 year follow-up
To describe:
- (Pre-implementation) expectations regarding ICG
- (Post-implementation) experiences regarding ICG including success factors and
barriers.
- The process of the learning curve
To provide:
- National guidelines for ICG implementation
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 radioguided surgery with radioisotope
technetium (99mTc). However, the use of 99mTc may present adverse effects and
is logistical challenging. An alternative method is fluorescence imaging using
Indocyanine Green (ICG).A recently published study (INFLUENCE trial) showed
that ICG is a safe and effective method for SLN mapping in breast cancer
patients with equal detection rates compared to Technetium.
Study objective
The objective of this study is to evaluate the (nationwide and international)
implementation of ICG-fluorescence for SN-procedures for patients with breast
cancer.
Study design
The INFLUENCE-II study is a (national and international) multicenter,
prospective, pre-post implementation study describing the implementation of
Indocyanine Green fluorescence imaging for SLN mapping in patients with breast
cancer.
Intervention
Phase I (pre-implementation)
The standard of care SLN procedure will be performed, which implies 99mTc
injection, the day or the morning before surgery. Study outcomes will be
registered during SN-procedures. Questionnaires regarding ICG-related
expectations will be collected.
Phase II (transition period)
In the transition period patients receive dual injection with both
99mTc-nanocolloid and ICG. Workshops and hands-on courses will be provided by
initiating hospital. No study-related registrations during SN procedures in
this phase are performed. Surgeons register the number of dual procedures
needed to proceed to the use of ICG alone.
Phase III (post-implementation)
The SN-procedure is performed with the use of ICG as single tracer. Study
outcomes will be registered during SN-procedures. Questionnaires regarding
ICG-related experiences will be collected.
Study burden and risks
This study has no burden or risks for study participation
Soestwetering 1
Utrecht 3543
NL
Soestwetering 1
Utrecht 3543
NL
Listed location countries
Age
Inclusion criteria
- Clinically node-negative, DCIS or invasive breast cancer confirmed by biopsy.
- Preoperative axillary ultrasound to confirm clinical node-negative status.
- Indication for SLN procedure via axillary excision
- Written informed consent according to ICH/GCP and national regulations.
Exclusion criteria
- Patients < 18 years old.
- SN-procedure via mastectomy incision
- Combined MARI procedure
- History of axillary lymph node dissection
- 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
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 | NL79223.100.22 |