An interventional study of Indocyanine green in Breast Cancer, sponsored by Centro di Riferimento Oncologico - Aviano. Status unknown at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Centro di Riferimento Oncologico - Aviano · Not applicable, Interventional, and Other
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 infiltrating/micro-infiltrating carcinoma.The 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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 10 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Centro di Riferimento Oncologico - Aviano is the lead sponsor of 50 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
Subdermal injection of 2,5 mg (1 cc) of ICG will be performed 3 weeks before surgery
Drug: Indocyanine green
Subdermal injection of 2,5 mg (1 cc) of ICG
Permanence of fluorescence at the level of axillary lymph nodes at 2-3 weeks after subcutaneous injection of Indocyanine Green (2.5 mg), in patients who will undergo radical axillary surgery
Frequency of patient with at least 3 fluorescent lymph nodes
Time frame: up to 3 weeks
Identification of the total number of fluorescent lymph nodes
Absolute frequency of total number of fluorescent lymph nodes per patient
Time frame: up to 3 weeks
Differences in the qualitative assessment (intensity) of fluorescence between the removed lymph nodes: lymph nodes will be divided into group A "intense fluorescence" and group B "mild fluorescence"
Absolute frequency of lymph nodes in group A and in group B
Time frame: up to 3 weeks
Association between histological positivity for metastases in sentinel and non-sentinel lymph nodes
Frequency of lymph nodes with metastases resulting fluorescent
Time frame: up to 3 weeks
Association between the patient's demographic/clinical variables and the presence or absence of fluorescent lymph nodes
Frequency of fluorescent and non-fluorescent lymph nodes between subgroups of patients with different demographic and clinical characteristics
Time frame: up to 3 weeks
Start is estimated for Sep 2024; primary completion for Aug 2025, 11 months later.
Of 2,272 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 11 months is below that.
Counting every sponsor, half of 2,345 studies reached it within 34 months; a quarter within 16 and three quarters within 69.
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This study is status unknown, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Indocyanine Green
Centro di Riferimento Oncologico - Aviano