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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel lymph node identification | Procedure | Intervention description: Intraoperative identification of sentinel lymph node | ||
| indocyanine green | Drug | 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 | ||
| methylene blue | Drug | 1%), 2-5 mL administered by periareolar or peritumoural route | ||
| Technetium (99mTc) | Drug | (99mTc, 0.2 - 0.4 mCi in 0.4 mL administered by periareolar or peritumoural route |
| Measure | Description | Time Frame |
|---|---|---|
| Sentinel lymph node detection rate | Rate of detection of at least one sentinel lymph node by indocyanine green | Time of Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Patient age | At visit 1 (pre-operative consultation) |
| Height | Patient height | At visit 1 (pre-operative consultation) |
| Measure | Description | Time Frame |
|---|---|---|
| Sentinel lymph node detection rate by obesity status | 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 | Time of surgery |
| Sentinel lymph node detection rate in early-stage breast cancer |
Inclusion Criteria:
Exclusion Criteria:
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The study will be conducted at French hospitals involved in the management of female patients with breast cancer where indocyanine green is used in routine practice. Patients will be enrolled from approximately 5 sites in metropolitan France.
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| Name | Affiliation | Role |
|---|---|---|
| Céline Chauleur, MD | CHU de Saint-Etienne | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Annecy-Genevois | Annecy | Epagny Metz-Tessy, Haute-Savoie | 74370 | France | ||
| Institut Bergonié |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31061432 | Background | Vermersch C, Raia-Barjat T, Chapelle C, Lima S, Chauleur C. Randomized comparison between indocyanine green fluorescence plus 99mtechnetium and 99mtechnetium alone methods for sentinel lymph node biopsy in breast cancer. Sci Rep. 2019 May 6;9(1):6943. doi: 10.1038/s41598-019-43473-3. | |
| 29096643 | Background |
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| Weight | Patient weight | At visit 1 (pre-operative consultation) |
| BMI | Patient BMI | At visit 1 (pre-operative consultation) |
| Comorbidities | Comorbidities of interest | At visit 1 (pre-operative consultation) |
| Menopause status | Menopause status | At visit 1 (pre-operative consultation) |
| Prior excisional surgery | Prior excisional surgery on the breast | At visit 1 (pre-operative consultation) |
| Surgery type planned | Type of breast surgery planned | At visit 1 (pre-operative consultation) |
| Tumour size | Tumour size | At visit 1 (pre-operative consultation) |
| Tumour grade | Tumour grade | At visit 1 (pre-operative consultation) |
| Tumour stage | Tumour stage | At visit 1 (pre-operative consultation) |
| Histological type | Tumour histological type | At visit 1 (pre-operative consultation) |
| Hormone receptor status | Tumour hormone receptor status (estrogen receptors, progesterone receptors, and HER2 status) | At visit 1 (pre-operative consultation) |
| Tumour laterality | Tumour laterality | At visit 1 (pre-operative consultation) |
| Tumour quadrant | Tumour quadrant | At visit 1 (pre-operative consultation) |
| Detection method | Method used to detect sentinel lymph node (indocyanine green alone or in combination with blue dye or 99mTc) | Time of surgery |
| Indocyanine green dose | Dose of indocyanine green | Time of surgery |
| Indocyanine green volume | Volume of indocyanine green | Time of surgery |
| Injection site | Description of injection site | Time of surgery |
| Number of injection sites | Number of injection sites | Time of surgery |
| Route of injection | Route of injection (periareolar or peritumoural) | Time of surgery |
| Detection equipment | Equipment used for detection of sentinel lymph node | Time of surgery |
| Number of sentinel lymph node biopsies performed | Number of sentinel lymph node biopsies performed | Time of surgery |
| Time from injection to visualization | Time from injection to visualization of first sentinel lymph node | Time of surgery |
| Time from injection to end of biopsy | Time from injection to end of biopsy procedure | Time of surgery |
| Number of sentinel lymph nodes detected | Number of sentinel lymph nodes detected (by all detection methods) per patient | Time of surgery |
| Number of sentinel lymph nodes detected - indocyanine green | Number of sentinel lymph nodes detected (by indocyanine green) per patient | Time of surgery |
| Number of sentinel lymph nodes detected - blue dye | Number of sentinel lymph nodes detected (by blue dye) per patient | Time of surgery |
| Number of sentinel lymph nodes detected - 99mTc | Number of sentinel lymph nodes detected (by 99mTc) per patient | Time of surgery |
| Adverse events | Number, frequency, grade, and outcomes of adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA | From time of surgery up to 6 weeks post-surgery |
| Serious adverse events | Number frequency, and outcomes of serious adverse events related to indocyanine green, using CTCAE v5 criteria/MedDRA | From time of surgery up to 6 weeks post-surgery |
| Changes in vital signs | Number of observed clinically significant changes in blood pressure, pulse rate, and respiratory rate | From time of surgery up to 6 weeks post-surgery |
Rate of detection of at least one sentinel lymph node by indocyanine green in patients with stage 1A, 1B, or 2A breast cancer |
| Time of surgery |
| Sentinel lymph node detection rate by indocyanine green dose | Rate of detection of at least one sentinel lymph node by indocyanine green for patients receiving 5 mg dose vs 10 mg dose | Time of surgery |
| Sentinel lymph node detection rate by injection route | Rate of detection of at least one sentinel lymph node by indocyanine green for patients injected via periareolar vs peritumoural vs subcutaneous route | Time of surgery |
| Bordeaux |
| Gironde |
| 33000 |
| France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | 54500 | France |
| CHU de Lille | Lille | Nord | 59000 | France |
| CHU de Saint-Etienne | Saint-Étienne-de-Montluc | Pays de la Loire Region | 42100 France | France |
| Hôpital Européen Georges-Pompidou Paris | Paris | Île-de-France Region | 75015 | France |
| Guo J, Yang H, Wang S, Cao Y, Liu M, Xie F, Liu P, Zhou B, Tong F, Cheng L, Liu H, Wang S. Comparison of sentinel lymph node biopsy guided by indocyanine green, blue dye, and their combination in breast cancer patients: a prospective cohort study. World J Surg Oncol. 2017 Nov 2;15(1):196. doi: 10.1186/s12957-017-1264-7. |
| 16110291 | Background | Kitai T, Inomoto T, Miwa M, Shikayama T. Fluorescence navigation with indocyanine green for detecting sentinel lymph nodes in breast cancer. Breast Cancer. 2005;12(3):211-5. doi: 10.2325/jbcs.12.211. |
| 26275781 | Background | Sugie T, Kinoshita T, Masuda N, Sawada T, Yamauchi A, Kuroi K, Taguchi T, Bando H, Yamashiro H, Lee T, Shinkura N, Kato H, Ikeda T, Yoshimura K, Ueyama H, Toi M. Evaluation of the Clinical Utility of the ICG Fluorescence Method Compared with the Radioisotope Method for Sentinel Lymph Node Biopsy in Breast Cancer. Ann Surg Oncol. 2016 Jan;23(1):44-50. doi: 10.1245/s10434-015-4809-4. Epub 2015 Aug 15. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| D008751 | Methylene Blue |
| D013667 | Technetium |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D004603 | Elements, Radioactive |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019216 | Metals, Heavy |
| D028561 | Transition Elements |
| D011868 | Radioisotopes |
| D007554 | Isotopes |
| D008670 | Metals |
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