Sentinel lymph node detection in thyroid carcinoma using 68Ga-tilmanocept PET/CT: A proof of concept study
- Conditions
- Thyroid cancerthyroid carcinoma10014713
- Registration Number
- NL-OMON55234
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Number of SLNs determined on PET/CT<br /><br>* Number of resected SLNs</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Localization of SLNs<br /><br>* Pathology result of SLN compared to pathology result of rest of lymph node<br /><br>level<br /><br>* Optimal scan protocol<br /><br>* Surgical time<br /><br>* Questionnaire directed to the surgeon about complexity, feasibility and<br /><br>additional value of various identification methods for SLNs</p><br>