Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347354
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-29
Brief Title:
Permanence of Indocyanine Green in Axillary Lymph Nodes 3 Weeks After Subdermal Injection in Patients With Breast Cancer and Metastatic Lymph Nodes
Sponsor:
Centro di Riferimento Oncologico - Aviano
Organization:
Centro di Riferimento Oncologico - Aviano
Study Overview
Official Title:
Permanence of Indocyanine Green in Axillary Lymph Nodes 3 Weeks After Subdermal Injection in Patients With Braast Cancer and Metastatic Lymph Nodes FLUO
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLUO
Brief Summary:
In the case of a pre-operative diagnosis of ductal carcinoma in situ DCIS sentinel lymph node biopsy is generally not indicated whereas it is considered standard clinical practice for patients with clinical stage I-II infiltrating breast cancer who have clinically negative axillary lymph nodes or clinically suspicious lymph nodes with negative needle aspiration findings It is not uncommon that in patients with ductal carcinoma in situ at preoperative diagnosis there may be an upgrade on definitive histological examination due to the identification of foci of infiltration about one-fifth of cases requiring axillary lymph node biopsy in a second surgery Prospective studies have shown that the sentinel lymph node identification rate after recent breast-conserving surgery is suboptimal With regard to the false negative rate FNR several studies demonstrated that it could be associated with different techniques used for lymph node identification Lymph node biopsy by Indocyanine green ICG is capable of identifying the sentinel lymph node however there are no data in literature on the permanence of ICG in the lymph node system The knowledge of this data would allow the application of this method already considered safe for the identification of the sentinel lymph node at the time of breast surgery also in those situations in which the sentinel lymph node biopsy is postponed due to the upgrade of definitive histological diagnosis from carcinoma in situ to infiltratingmicro-infiltrating carcinomaThe main objective of this trial is to evaluate the permanence of fluorescence at the level of axillary lymph nodes 3 weeks after subcutaneous injection in patients who are candidates to radical axillary surgery Marking the sentinel lymph node before breast surgery in cases of DCIS with risk factors could reduce the false negative rate allowing to increase the accuracy of the procedure in identifying the lymph node potentially involved by metastatic infiltration In addition the identification of the sentinel lymph node in patients who are candidates to radical axillary surgery could increase the sensitivity of the surgery in staging axillary disease and could make the lymph node exeresis more targeted reducing the morbidity of the surgery resulting in a better outcome for the patient
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None