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This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided sentinel lymph node biopsy in patients with cancers and subjected to surgery.
The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope (Techniciun99) in the detection of sentinel lymph nodes will be assess using an "Optonuclear" probe (EURORAD S.A.) and QUEST camera
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sentinel lymph node detection | Experimental | Each patient receive both injections of Technetium99 (standard care) and indocyanine green. The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green | Drug | Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of indocyanine green guided sentinel lymph node biopsy | The detection rate is defined by the number of patient who at least one sentinel node detected by fluorescence or isotope intra operatively. Per-operative detection is defined by the identification of at least one sentinel lymph node in the lymphatic drainage area. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of sentinel lymph node detected | The total number of sentinel node detected will be assess by the two techniques | 1 day |
| Number of false negative result | False negative result is defined by number of patients with at least one hot metastatic sentinel lymph node without fluorescent metastatic sentinel lymph node |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MARCHAL FREDERIC, MD, PU-PH | Institut de Cancérologie de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
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|
| Technetium99 | Drug | Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery. Lymphoscintigraphy is performed to identify the sentinel node |
|
|
| Optonuclear probe | Device | The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery. |
|
| Quest Camera | Device | The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery. |
|
| 1 day |
| Allergic reactions | Percentage of patients with allergic reactions | 8 days |
| Evaluation of pain | Pain will be assessed by a numerical scale from 0 (no pain) to 10 (maximum pain) | 1 day |
| fluorescence imaging | The total number of sentinel node detected by fluorescence imaging | 1 day |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D008545 | Melanoma |
| D002294 | Carcinoma, Squamous Cell |
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D010051 | Ovarian Neoplasms |
| D014846 | Vulvar Neoplasms |
| D001005 | Anus Neoplasms |
| D012004 | Rectal Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018307 | Neoplasms, Squamous Cell |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014845 | Vulvar Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| C116320 | Infracyanine green |
| C000615519 | Technetium-99 |
| C512413 | nanocis |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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