An interventional study of ICG used as a tracer for sentinel lymph node and technetium 99 used as a tracer for sentinel lymph node in Breast Cancer, sponsored by Casa di Cura Dott. Pederzoli. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Casa di Cura Dott. Pederzoli · Not applicable, Interventional, and Other
This single-institution pilot study uses a pre- and post-implementation design to evaluate the implementation of ICG fluorescent imaging for sentinel lymph node biopsy (SLNB) in an Italian hospital.
Pre-implementation: standard sentinel node procedure using 99mTc-nanocolloid, which implies 99mTc injection the day or the morning before surgery. Transition period: participating surgeons will receive on-site training, proctoring, and ongoing guidance from experienced surgeons and early adopters of the ICG method from St. Antonius Hospital, Utrecht, The Netherlands until they achieve confidence and proficiency in using ICG for SLNB. Post-implementation: 5 mg (2 ml) ICG will be injected periareolar after administration of general anesthesia and before incision. The SLN will be visualized by fluorescent imaging using a fluorescence camera.
Main study endpoints: Primary endpoint is the identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG. Secondary endpoints are total number of LNs removed, detection time, total operative time, complications and (serious) adverse events, loco regional recurrence after 1 year follow-up, pre-implementation expectations regarding ICG, post-implementation experiences regarding ICG including barriers and success factors.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Casa di Cura Dott. Pederzoli is the lead sponsor of 15 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
radioisotope technetium technique will be used for sentinel lymph node localization(99mTc)
Procedure: technetium 99 used as a tracer for sentinel lymph node
indocyanine green fluorescent imaging technique will be used for sentinel lymph node localization (ICG)
Procedure: ICG used as a tracer for sentinel lymph node
ICG used as a tracer for sentinel lymph node instead of technetium 99
technetium 99 used as a tracer for sentinel lymph node instead of ICG
Identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG
measure the percentage of sentinel lymph nodes identified by the 99mTc nanocolloid or the ICG fluorescent signal (%)
Time frame: through study completion, an average of 1 year
Percentage of SLNs that has 99mTc uptake/ is fluorescent
Percentage of sentinel lymph nodes that have an absorption of 99mTc and are fluorescent (%)
Time frame: through study completion, an average of 1 year
Detection time
Detection time is defined as time between skin incision and SLN resection in minutes (min)
Time frame: through study completion, an average of 1 year
Total operative time
Registration of the duration of the total surgical procedure including the SN-procedure (min or h)
Time frame: through study completion, an average of 1 year
Number of complications and (serious) adverse events
registration of the number of serious adverse events and complications, including seroma, wound infection and bleeding
Time frame: through study completion, an average of 1 year
loco regional recurrence after 1 year follow-up
number of regional loco recurrences assessed through clinical examinations
Time frame: through study completion, an average of 1 year
The pathology of SLNs identified
number of micro and macro metastases and isolated tumor cells (ITCs)
Time frame: through study completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Casa di Cura Dott. Pederzoli