Sentinelklier opsporing bij borstcarcinoom door middel van de nieuw beschikbare tracer “Tilmanocept” of de gebruikelijke tracer “Nanocoll” – vergelijking van de tracerverdeling over de tijd.

Dynamics and tracer distribution of Tilmanocept using combined subareolar and peritumoral injection technique for scintigraphic sentinel lymph node detection in early stage breast cancer.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002597-32-BE

Enrollment

Registered

2019-11-28

Start date

2020-03-16

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early stage breast cancer (T1, T2) MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Lymphoseek Product Name: Lymphoseek Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: tilmanocept CAS Number: 1185986-76-8 Other descriptive name: TILMANOCE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Women with newly diagnosed stage 1 or 2 breast cancer - Clinically “node negative” (no clinically enlarged lymph nodes) - Equal or more than 18 years old Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: - Pregnancy - Previous surgery in the same breast

Design outcomes

Primary

Measure	Time frame
Main Objective: Documenting the distribution of 99m-Tc Tilmanocept at multiple timepoints post-injection (combined peritumoral and subareolar) and comparing this data with the distribution of 99m-Tc nanocoll at the same timepoints.;Secondary Objective: Not applicable;Primary end point(s): Time to identification of first lymph node;Timepoint(s) of evaluation of this end point: Lymph node count to background ratio 4 hours post-injection Lymph node count to background ratio 24 hours post-injection Injection site count to background ratio 4 hours post-injection Injection site count to background ratio 24 hours post-injection	—

Measure

Time frame

Main Objective: Documenting the distribution of 99m-Tc Tilmanocept at multiple timepoints post-injection (combined peritumoral and subareolar) and comparing this data with the distribution of 99m-Tc nanocoll at the same timepoints.;Secondary Objective: Not applicable;Primary end point(s): Time to identification of first lymph node;Timepoint(s) of evaluation of this end point: Lymph node count to background ratio 4 hours post-injection Lymph node count to background ratio 24 hours post-injection Injection site count to background ratio 4 hours post-injection Injection site count to background ratio 24 hours post-injection

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactHIRUZ CTU

University Hospital Ghent

hiruz.ctu@uzgent.be+329 3320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026