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Trial Title:
Permanence of Indocyanine Green in Axillary Lymph Nodes 3 Weeks After Subdermal Injection in Patients With Breast Cancer and Metastatic Lymph Nodes
NCT ID:
NCT06347354
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Indocyanine green
Description:
Subdermal injection of 2,5 mg (1 cc) of ICG
Arm group label:
Subdermal injection of 2,5 mg (1 cc) of ICG
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Written informed consent must be obtained and documented before starting
protocol-specific procedures and follow-up, according to local regulatory
requirements.
- >18 years old
- Breast cancer patients with cyto-histologically ascertained lymph node metastases
and candidates for quadrantectomy/mastectomy combined with radical axillary surgery
Exclusion Criteria:
- patients allergic to Iodine or Indocyanine Green
- patients with thyroid diseases (hyperthyroidism, autoimmune thyroid adenomas)
- patients who are not candidates for radical axillary surgery
- pregnant patients
- underage patients
- interdicted patients or patients requiring a support administrator
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Contact:
Last name:
Stefano Fracon, MD
Phone:
0434659317
Email:
stefano.fracon@cro.it
Contact backup:
Last name:
Samuele Massarut, MD
Email:
smassarut@cro.it
Investigator:
Last name:
Stefano Fracon, MD
Email:
Principal Investigator
Start date:
September 2024
Completion date:
August 2025
Lead sponsor:
Agency:
Centro di Riferimento Oncologico - Aviano
Agency class:
Other
Source:
Centro di Riferimento Oncologico - Aviano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06347354
