Breast Cancer
Conditions
Keywords
sentinel lymph node biopsy, indocyanine green biopsy, fluorescence blue dye, technetium99
Brief summary
This prospective, observational study will evaluate the patient-based sentinel lymph node detection rate when using the Infracyanine® (indocyanine green) dye technique in patients undergoing surgery for breast cancer. The study will describe the demographic, clinical, and tumour characteristics of patients with breast cancer undergoing surgery. The study will describe the characteristics of how the indocyanine green dye technique is used including the dose and volume of dye used, the number and type of injection sites used to give the dye, the equipment used to detect the dye and locate the sentinel lymph node, and whether indocyanine green is used on its own or with other dyes (blue dye and/or 99mTechnetium dye). The study will evaluate the characteristics of sentinel lymph node biopsy procedures performed using indocyanine green dye including the number of biopsies performed, the time taken to detect the sentinel lymph node and perform the biopsy, and how many sentinel lymph nodes are detected using indocyanine green dye, blue dye, and 99mTechnetium dye. The study will also assess the safety of using indocyanine green dye for 6 weeks following surgery.
Interventions
PROCEDURESentinel lymph node identification
Intervention description: Intraoperative identification of sentinel lymph node
DRUGindocyanine green
Intervention description: indocyanine green (5 to 10 mg \[ie, 2 to 4 mL of a 2.5 mg/mL solution\]) administered by periareolar or peritumoural route
DRUGmethylene blue
1%), 2-5 mL administered by periareolar or peritumoural route
(99mTc, 0.2 - 0.4 mCi in 0.4 mL administered by periareolar or peritumoural route
Sponsors
Iqvia Pty Ltd
BTG International Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female * Aged ≥18 years * Undergoing breast cancer surgery with an indication for sentinel lymph node biopsy * Receiving Infracyanine® (indocyanine green; alone or in combination with blue dye or 99mTc) for intraoperative identification of sentinel lymph node according to the Summary of Product Characteristics
Exclusion criteria
* Male * Pregnant or nursing female * Previous allergy to indocyanine green or to any excipients * Already included in a surgical trial * Patient opposed to collection and processing of their data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sentinel lymph node detection rate | Time of Surgery | Rate of detection of at least one sentinel lymph node by indocyanine green |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumour quadrant | At visit 1 (pre-operative consultation) | Tumour quadrant |
| Number of sentinel lymph nodes detected - 99mTc | Time of surgery | Number of sentinel lymph nodes detected (by 99mTc) per patient |
| Adverse events | From time of surgery up to 6 weeks post-surgery | Number, frequency, grade, and outcomes of adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA |
| Serious adverse events | From time of surgery up to 6 weeks post-surgery | Number frequency, and outcomes of serious adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA |
| Changes in vital signs | From time of surgery up to 6 weeks post-surgery | Number of observed clinically significant changes in blood pressure, pulse rate, and respiratory rate |
| Tumour grade | At visit 1 (pre-operative consultation) | Tumour grade |
| Tumour stage | At visit 1 (pre-operative consultation) | Tumour stage |
| Histological type | At visit 1 (pre-operative consultation) | Tumour histological type |
| Age | At visit 1 (pre-operative consultation) | Patient age |
| Height | At visit 1 (pre-operative consultation) | Patient height |
| Weight | At visit 1 (pre-operative consultation) | Patient weight |
| BMI | At visit 1 (pre-operative consultation) | Patient BMI |
| Comorbidities | At visit 1 (pre-operative consultation) | Comorbidities of interest |
| Menopause status | At visit 1 (pre-operative consultation) | Menopause status |
| Prior excisional surgery | At visit 1 (pre-operative consultation) | Prior excisional surgery on the breast |
| Surgery type planned | At visit 1 (pre-operative consultation) | Type of breast surgery planned |
| Tumour size | At visit 1 (pre-operative consultation) | Tumour size |
| Hormone receptor status | At visit 1 (pre-operative consultation) | Tumour hormone receptor status (estrogen receptors, progesterone receptors, and HER2 status) |
| Tumour laterality | At visit 1 (pre-operative consultation) | Tumour laterality |
| Detection method | Time of surgery | Method used to detect sentinel lymph node (indocyanine green alone or in combination with blue dye or 99mTc) |
| Indocyanine green dose | Time of surgery | Dose of indocyanine green |
| Indocyanine green volume | Time of surgery | Volume of indocyanine green |
| Injection site | Time of surgery | Description of injection site |
| Number of injection sites | Time of surgery | Number of injection sites |
| Route of injection | Time of surgery | Route of injection (periareolar or peritumoural) |
| Detection equipment | Time of surgery | Equipment used for detection of sentinel lymph node |
| Number of sentinel lymph node biopsies performed | Time of surgery | Number of sentinel lymph node biopsies performed |
| Time from injection to visualization | Time of surgery | Time from injection to visualization of first sentinel lymph node |
| Time from injection to end of biopsy | Time of surgery | Time from injection to end of biopsy procedure |
| Number of sentinel lymph nodes detected | Time of surgery | Number of sentinel lymph nodes detected (by all detection methods) per patient |
| Number of sentinel lymph nodes detected - indocyanine green | Time of surgery | Number of sentinel lymph nodes detected (by indocyanine green) per patient |
| Number of sentinel lymph nodes detected - blue dye | Time of surgery | Number of sentinel lymph nodes detected (by blue dye) per patient |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sentinel lymph node detection rate by indocyanine green dose | Time of surgery | Rate of detection of at least one sentinel lymph node by indocyanine green for patients receiving 5 mg dose vs 10 mg dose |
| Sentinel lymph node detection rate by injection route | Time of surgery | Rate of detection of at least one sentinel lymph node by indocyanine green for patients injected via periareolar vs peritumoural vs subcutaneous route |
| Sentinel lymph node detection rate by obesity status | Time of surgery | Rate of detection of at least one sentinel lymph node by indocyanine green in obese (BMI ≥30 kg/m2) vs non-obese (BMI ≤30 kg/m2) patients |
| Sentinel lymph node detection rate in early-stage breast cancer | Time of surgery | Rate of detection of at least one sentinel lymph node by indocyanine green in patients with stage 1A, 1B, or 2A breast cancer |
Countries
France
Outcome results
None listed