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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004005-32 | EudraCT Number |
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The sentinel node has a fundamental role in the management of early breast cancer.
Currently, the double detection of blue and radioisotope is recommended. A radioactive material requires the presence of a nuclear medicine department and the approval of health authorities. In many centers, this technique is not available. The use of blue is easier to implement technique. However, allergic reactions and prolonged breast tattoo led many teams to stop the practice.
So in common practice, many center use a single method. However, with a single detection, the risk of false negatives and the identification failure rate increased to a significant extent and the number of sentinel lymph node detected and removed is not enough.
Under these conditions, find another method of detection seems crucial. According to the literature, the fluorescence method (ICG) is a technique that seems safe and reliable.
The investigators therefore propose a prospective, randomized study to investigate the interest of fluorescence associated with the isotopic method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| double detection Indocyanine + isotope | Experimental | intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery |
|
| isotope detection alone | Active Comparator | intradermal injection of 20 MBq of technetium 99 before breast surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indocyanine green | Drug | One injection, 2.5 milligrams per patient, intradermal use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Less Than Two Lymph Nodes Detected | Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone | peroperative |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Lymph Nodes ICG Positive and Tc Positive | Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive | Peroperative |
| Number of Lymph Nodes ICG Positive and Tc Negative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Céline CHAULEUR, PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Saint-Etienne | Saint-Etienne | 42055 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Double Detection Indocyanine + Isotope | intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery indocyanine green: One injection, 2.5 milligrams per patient, intradermal use isotope: One injection, 20 MBq techntium99, intradermal use |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| isotope | Drug | One injection, 20 MBq techntium99, intradermal use |
|
|
Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative
| Peroperative |
| Number of Lymph Nodes ICG Negative and Tc Positive | Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive | Peroperative |
| Comparison Between Groups of the Time of the Surgery | time from incision to wound closure | Peroperative |
| Comparison Between Groups of Anesthesia Time | time from the injection of anesthesic to the waking | Peroperative |
| Time From Injection of One Dose ICG Injection to Incision Time | time from injection of one dose ICG injection to incision time | Peroperative |
| Comparison Between Groups of Time Surgery Node | time from incision time to the last node surgery | Peroperative |
| Number of Patients With ICG Allergy | allergy is : redness, edema, itching, larynges edema and/or allergic shock | peroperative |
| Number of Patients With ICG Allergy | allergy is : redness, edema, itching, larynges edema and/or allergic shock | 1 hour after the end of the surgery |
| Number of Patients With ICG Allergy | allergy is : redness, edema, itching, larynges edema and/or allergic shock | Month 2 |
| Isotope Detection Alone |
intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Double Detection Indocyanine + Isotope | intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery indocyanine green: One injection, 2.5 milligrams per patient, intradermal use isotope: One injection, 20 MBq techntium99, intradermal use |
| BG001 | Isotope Detection Alone | intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| height, continuous | Mean | Standard Deviation | cm |
| |||||||||||||||
| weight, continuous | Mean | Standard Deviation | kg |
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| age of first menstruation, continuous | data not find | Mean | Standard Deviation | years |
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| menopause | Data not found | Count of Participants | Participants |
| |||||||||||||||
| tumor size | data not found | Median | Inter-Quartile Range | mm |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Less Than Two Lymph Nodes Detected | Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone | Posted | Count of Participants | Participants | peroperative |
|
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| ||||||||||||||||||||||||||||||
| Secondary | Number of Lymph Nodes ICG Positive and Tc Positive | Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive | Posted | Number | lymph nodes | Peroperative | lymph nodes | lymph nodes |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Lymph Nodes ICG Positive and Tc Negative | Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative | Posted | Number | lymph nodes | Peroperative | Lymph nodes | Lymph nodes |
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| |||||||||||||||||||||||||||||
| Secondary | Number of Lymph Nodes ICG Negative and Tc Positive | Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive | Posted | Number | lymph nodes | Peroperative | lymph nodes | lymph nodes |
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| Secondary | Comparison Between Groups of the Time of the Surgery | time from incision to wound closure | Posted | Median | Inter-Quartile Range | minuts | Peroperative |
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| Secondary | Comparison Between Groups of Anesthesia Time | time from the injection of anesthesic to the waking | Posted | Median | Full Range | minutes | Peroperative |
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| Secondary | Time From Injection of One Dose ICG Injection to Incision Time | time from injection of one dose ICG injection to incision time | Posted | Median | Inter-Quartile Range | minutes | Peroperative |
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| Secondary | Comparison Between Groups of Time Surgery Node | time from incision time to the last node surgery | Posted | Median | Inter-Quartile Range | minuts | Peroperative |
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| Secondary | Number of Patients With ICG Allergy | allergy is : redness, edema, itching, larynges edema and/or allergic shock | Posted | Count of Participants | Participants | peroperative |
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| Secondary | Number of Patients With ICG Allergy | allergy is : redness, edema, itching, larynges edema and/or allergic shock | Posted | Count of Participants | Participants | 1 hour after the end of the surgery |
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| Secondary | Number of Patients With ICG Allergy | allergy is : redness, edema, itching, larynges edema and/or allergic shock | Posted | Count of Participants | Participants | Month 2 |
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2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double Detection Indocyanine + Isotope | intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery indocyanine green: One injection, 2.5 milligrams per patient, intradermal use isotope: One injection, 20 MBq techntium99, intradermal use | 0 | 50 | 0 | 50 | 16 | 50 |
| EG001 | Isotope Detection Alone | intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use | 0 | 49 | 0 | 49 | 13 | 49 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hematoma | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
| |
| lymphocele | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Céline CHAULEUR | CHU Saint-Etienne | 04 77 82 86 11 | +33 | celine.chauleur@chu-st-etienne.fr |
| 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 |
| D007554 | Isotopes |
| D013667 | Technetium |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007287 | Inorganic Chemicals |
| D004603 | Elements, Radioactive |
| D004602 | Elements |
| D019216 | Metals, Heavy |
| D028561 | Transition Elements |
| D011868 | Radioisotopes |
| D008670 | Metals |
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