The IMP will be used for the identification of sentinel lymph nodes in patients with thyroid carcinoma MedDRA version: 21.1 Level: PT Classification code 10066474 Term: Thyroid cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10072873 Term: Sentinel lymph node mapping System Organ Class: 100000004848 MedDRA version: 20.1 Level: LLT Classification code 10073554 Term: Sentinel node biops
Conditions
Interventions
Product Name: [68Ga]Ga-Tilmanocept
Pharmaceutical Form: Injection
INN or Proposed INN: Tilmanocept
CAS Number: 1262984-82-6
Concentration unit: MBq megabecquerel(s)
Concentration type: up to
Concentra
Sponsors
Univeristy Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria: • The patient has provided written informed consent authorization before participating in the study • Cytologic diagnosis of differentiated thyroid carcinoma (Bethesda 6) and will undergo a hemi- or total thyroidectomy, or cytologic diagnosis of medullary thyroid carcinoma(Bethesda 6) • The patient is =18 years of age at time of consent • The patient has an ECOG status of Grade 0 – 2 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Any of the following criteria: • The patient is incapacitated • The patient is pregnant or lactating • The patient has a history of neck dissection, gross injury or radiotherapy to the neck that would preclude reasonable surgical dissection for this trial • The patient will undergo minimally invasive thyroid surgery (via the axilla or trans-oral approach) • The patient is actively receiving systemic cytotoxic chemotherapy. • The patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy • The patient has a preoperatively histologically proven multifocal tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to prove the concept of sentinel lymph node imaging in thyroid carcinoma using preoperative 68Ga-tilmanocept PET/CT combined with intraoperative gamma probe and fluorescence camera localization. The number of visualized and resected SLNs will be assessed.;Secondary Objective: To •Assess the localization of the sentinel lymph nodes •Compare the pathological results of the sentinel lymp nodeswith the results of the rest of the lymph node level •Define the optimal scan protocol •Assess the (additional) surgical time •Quantify how the surgeon experiences the complexity, feasibility and additional value of the various methods to identify the sentinel lymph nodesusing a questionnaire ;Primary end point(s): •Number of sentinel lymph nodes determined on PET/CT •Number of resected sentinel lymph nodes ;Timepoint(s) of evaluation of this end point: Within 2 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Localization of sentinel lymph nodes • Pathology result of sentinel lymph nodes compared to pathology result of rest of lymph node level • Optimal scan protocol • (Additional) surgical time • Questionnaire directed to the surgeon about complexity, feasibility and additional value of various identification methods for sentinel lymph nodes ;Timepoint(s) of evaluation of this end point: Approximately 1-10 days | — |
Countries
Netherlands
Contacts
Public ContactClinical trial office
Univeristy Medical Center Utrecht
Outcome results
None listed