Efficacy of [18F]-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET) in Evaluation of Cytological indeterminate Thyroid nodules prior to Surgery: a multicentre cost-effectiveness study.

Completed

• Conditions: thyroid lump; thyroid nodule; 10014713

• Registration Number: NL-OMON50212
• Lead Sponsor: Radiologie & Nucleaire Geneeskunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 132

Inclusion Criteria

Summary of main criteria from protocol v2.0 paragraph 4.2:
In order to be eligible for participation, a subject must meet ALL of the
following criteria:
1. solitary thyroid nodule or dominant thyroid nodulus within multinodular
disease, cytologically indeterminate (Bethesda category III or IV)
2. Scheduled for surgical excision (preferably) within 2 months of the
inclusion date;
3. Age * 18 years;
4. Euthyroid state with a serum TSH or a free T4 level within the institutional
upper and lower limits of normal, measured within 2 months of registration. In
case of a suppressed TSH: a negative 123I, 131I or 99mTcO4- scintigraphy must
be available (*cold nodule*);
5. In patients with multi-nodular disease and a dominant nodule, the nuclear
medicine physician responsible for FDG-PET/CT scan interpretation must
determine whether the nodule is likely to be discriminated on FDG-PET/CT
imaging prior to enrolment;
6. Willing to participate in all aspects of the study;

Exclusion Criteria

Summary of main criteria from protocol v2.0 paragraph 4.3:
A subject who meets ANY of the following criteria will be excluded from
participation:
1. high prior probability of malignancy (e.g. proven malignant cytology:
Bethesda cat. V or VI, malignant lymphadenopathy, PET positive thyroid
incidentaloma, genetic predisposition of thyroid carcinoma, prior radiotherapy
to the neck, etc.)
2. proven benign disease or insufficient material for diagnosis (Bethesda cat.
II or I)
3. performance of additional non-routine diagnostic tests affecting patient
management (e.g. mutation analysis on cytology)
4. inability to undergo randomisation (i.e. scheduled thyroid resection for
other than diagnostic purposes)
5. inability to undergo treatment (i.e. inoperable patients)
6. Contra-indications for FDG-PET/CT (e.g. recent neck infection, poorly
regulated diabetes mellitus, pregnant, lactating, severely claustrophobic, etc.)
7. General (inability of informed consent, severe psychiatric disorder)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: The number of unbeneficial interventions, i.e.<br /><br>surgery for benign disease or watchful-waiting for malignancy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives: complication rate, consequences of incidental<br /><br>PET-findings, number of hospitalisation and sick leave days, volumes of<br /><br>healthcare consumed, experienced HRQoL, genetic, cytological and<br /><br>(immuno)histopathological features of the nodules.</p><br>