The aim of this proof-of-concept study is to investigate the feasibility of SLNB in thyroid carcinoma and optimize 68Ga-tilmanocept PET/CT the imaging protocol.
ID
Source
Brief title
Condition
- Endocrine neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Number of SLNs determined on PET/CT
* Number of resected SLNs
Secondary outcome
* 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
Background summary
Sentinel lymph node biopsy (SLNB) is a diagnostic staging procedure that is
routinely applied in a variety of tumor types, but is not used in daily
clinical practice for thyroid carcinoma. The procedure aims to identify the
first draining lymph node(s) (SLN(s)), which is most likely to contain
metastases if present. The histopathological status of the SLN should reflect
the histopathological status of the rest of the lymph node level and proven
metastases justify further lymph node dissection/additional treatment.
Detecting SLNs close to tumor sites is hampered, since the injection site of
the radiotracer, around the primary tumor, produces a large hotspot on
lymphoscintigraphy possibly hiding SLNs in close proximity of the primary tumor
(*shine through* effect). 68Ga-tilmanocept PET/CT is a new imaging modality
with high resolution, which may limit the *shine through* effect and may
provide improved localization of SLNs nearby the injection site.
Study objective
The aim of this proof-of-concept study is to investigate the feasibility of
SLNB in thyroid carcinoma and optimize 68Ga-tilmanocept PET/CT the imaging
protocol.
Study design
Proof-of-concept study including 10 patients.
Study burden and risks
Patients will undergo additional ultrasound guided, peritumoral injections and
two PET/CT-scans of the neck with a duration of 5 minutes. Information obtained
from 68Ga-tilmanocept PET/CT may be helpful in harvesting SLNs. The extra
administration of 10 MBq 68Ga-tilmanocept and 120 MBq ICG-99mTc-nanocolloid, is
considered an acceptable radiation burden to the patient. Adverse reactions
after injection of radiolabeled tilmanocept rarely occur. Additionally, the
lymph node level(s) containing the SLN will be dissected. In part of the
patients this dissection was already indicated.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-002470-42-NL |
| CCMO | NL72010.041.21 |