A Phase 4 interventional study of Tilmanocept and Nanocolloid in Breast Cancer and Sentinel Lymph Node, sponsored by University Hospital, Ghent. Withdrawn at 1 site in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-14.
Sponsored by University Hospital, Ghent · Phase 4, Interventional, and Diagnostic
A sentinel node procedure is recommended for patients with early stages of breast cancer to exclude metastases to local lymph nodes. This procedure is done with a "tracer" which is injected near to the tumor and drains to these nearby lymph nodes. The first draining lymph node(s) are called "sentinel" node(s). These sentinel nodes are excised by the surgeon for microscopic investigation using a detection probe. This study aims to further document the distribution and dynamics of a recently approved new tracer called Tilmanocept and comparing it with the standard used tracer (nanocolloid) to determine whether there is a significant difference between both products (which are both approved for clinical use in this scenario in the European Union). This will be done by randomly assigning patients between injection of Tilmanocept or Nanocolloid and making scans on multiple (3) time points.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
Browse Breast Neoplasms studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Tilmanocept
Drug: Nanocolloid
Combined peri-areolar and peri-tumoral injection of 99m-Tc Tilmanocept
Combined peri-areolar and peri-tumoral injection of 99m-Tc Nanocolloid
Also known as: Nanoscint
Time to identification of first lymph node
Time to identification of first lymph node on the dynamic acquisition during the first 30 minutes post-injection
Time frame: 0-30 minutes
Lymph node count to background ratio 4 hours post-injection
Number of identified lymph nodes and count-to-background ratio in these identified lymph nodes obtained by SPECT/CT 4 hours post-injection
Time frame: 4 hours post-injection
Lymph node count to background ratio 24 hours post-injection
Number of identified lymph nodes and count-to-background ratio in these identified lymph nodes obtained by SPECT/CT 24 hours post-injection
Time frame: 20 to 24 hours post-injection
Injection site count to background ratio 4 hours post-injection
Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 4 hours post-injection
Time frame: 4 hours post-injection
Injection site count to background ratio 24 hours post-injection
Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 24 hours post-injection
Time frame: 20 to 24 hours post-injection
Plan to share: No
This study is withdrawn, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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.
University Hospital, Ghent