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Sentinel lymph node detection in thyroid carcinoma using 68Ga-tilmanocept PET/CT: A proof of concept study

Sentinel lymph node detection in thyroid carcinoma using 68Ga-tilmanocept PET/CT: A proof of concept study - 68Ga-tilmanocept sentinel lymph node PET/CT imaging in thyroid cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55234
Enrollment
10
Registered
2021-10-13
Start date
2021-12-31
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

Thyroid cancer thyroid carcinoma

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

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

MeasureTime frame
* Number of SLNs determined on PET/CT * Number of resected SLNs

Secondary

MeasureTime frame
* Localization of SLNs * Pathology result of SLN compared to pathology result of rest of lymph node level * Optimal scan protocol * Surgical time * Questionnaire directed to the surgeon about complexity, feasibility and additional value of various identification methods for SLNs

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)