Assessment of Repeat Fine Needle Aspiration (FNA) to Detect Thyroid Cancer (CYT2THYR)
Thyroid nodules are common (prevalence of 12.7% in women), but are malignant in only 5% of cases. International experts agree that a preliminary cytological examination by fine needle aspiration (FNA) is required. The management of patients with cytological results consistent with malignant or suspicious for malignancy nodules is well codified and generally involves surgery. However, there is no consensus concerning 1) the utility of a second FNA during the monitoring of benign nodules. Certain studies have recommended a second FNA, whereas others have recommended ultrasound monitoring alone; 2) the contribution of ultrasound criteria to the decision as to whether to carry out a second FNA, particularly if the nodule increases in size; 3) the management of nodules classified as doubtful or suspect on needle biopsy, many of which prove to be benign (20 to 30% are malignant), raising questions about the utility of systematic thyroid surgery or the justification for a second FNA; 4) the management of patients with non significant (NS) findings on FNA, for whom immediate surgery, monitoring or a second FNA may be recommended and 5) the procedure to be followed for nodules present in patients with multinodular thyroid disease.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Utility of a Second Ultrasound-guided Fine Needle Aspiration for the Detection of Thyroid Cancer in the Management of Single Thyroid Nodules or Multinodular Goitre.|
- Status nodule [ Time Frame: Inclusion, 6, 12 and 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Fine needle aspiration
Patient with solid nodules more than 10 mm in diameter will be biopsied by ultrasound-guided fine-needle aspiration(FNA)after consultation with an endocrinologist or ENT specialist.
Procedure: Fine needle aspiration
Classical needle biopsy techniques will be used, with patients lying on their backs with their necks in hyperextension. An initial ultrasound scan will be used to determine the site or sites at which the needle should be inserted. Following extensive disinfection of the skin of the neck, the needle will be inserted under ultrasound guidance. The needle will be moved gently backwards and forwards and displaced radially in a clockwise direction to recover cellular material by capillarity. In general, several (two or three) passages of the needle are required for a given nodule. It is possible to carry out FNA on up to three nodules in a single session. For each passage, a new, sterile, single-use needle will be used. The insertion of each needle will be preceded by an ultrasound scan.
Other Name: Fine needle aspiration under ultrasonography
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00954837
|Principal Investigator:||Marie LALOI-MICHELIN, MD||Assistance Publique - Hôpitaux de Paris|