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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.

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Thyroid Cancer

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Trial Information

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.

Background :

A few studies have tried to evaluate the value of a second needle biopsy. Ultrasound
criteria for malignancy have been described but are mostly unvalidated. Only a very small
number of immunocytochemical studies using several antibodies have been reported, mostly
dealing with series of less than 50 cases. The Bethesda State of Science Conference held in
October 2007 (ahead on print, 2009) on fine-needle biopsy of the thyroid considered that no
sufficiently robust studies of this technique had yet been carried out and that prospective
studies were required.


The principal objective of this study is to determine the utility of a second needle biopsy
in the routine management of patients presenting, for a given nodule, initial cytological
results that were non-significant, benign, doubtful or suspect. The secondary objectives are
to determine the utility of various pre-determined ultrasound criteria and of the collection
of cells in liquid medium combined with immunocytochemistry.


Prospective study on a cohort of 400 patients attending consultations in the Internal
Medicine/Endocrinology Department or the ENT Department, or referred by external doctors,
whether working in hospitals or in private practice, participating in a protocol of single
or multiple thyroid nodule disease assessment. Each patient will attend at least one
consultation and undergo at least one thyroid ultrasound scan with fine-needle aspiration
(FNA). Based on the result of this first needle biopsy, management will be oriented towards
immediate surgery or follow-up for 6/12 or 18 months, with a second thyroid needle biopsy
within a maximum of 18 months of follow-up.

Inclusion period: 18 months Duration of follow-up: up to18 months Total duration of the
study: 36 months

Description of the techniques used in this protocol:

Radiological techniques :

They will then undergo ultrasound-guided fine-needle aspiration (FNA). 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. The material recovered will be diluted in 30 ml of CYTOLYT
(Hologic), a transport medium for the recuperation of cells in liquid media. 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.

Surgical technique:

For all nodules for which surgery is indicated, LOBOISTHMECTOMY will be carried out with
frozen sections (FS). There are three possibilities: 1) FS provides evidence of thyroid
cancer. In such cases, total thyroidectomy is carried out, with dissection of the lymph
nodes areas in the central (zone VI) and lateral (zones II to IV) zones on each side; 2) FS
provides no evidence of malignancy. In such cases, the surgical intervention is limited to
LOBOISTHMECTOMY; 3) FS shows the nodule in question to be suspect. In such cases, total
thyroidectomy is not carried out before the definitive pathological results are known. It is
widely accepted that recurrent dissection should also be carried out during this initial
surgery. Indeed, if the definitive pathological examination shows the nodule to be
cancerous, repeat surgical interventions with recurrent dissection are potentially much more
damaging to the recurrent nerve.

If there is an indication for total thyroidectomy due to the presence of multiple nodules or
multinodular goitre, FS is carried out for the entire thyroid, with sampling directed by the
pathologist to determine whether central and lateral zone dissection should be carried out.

The sampling circuit :

All solid nodules more than 10 mm in diameter will be biopsied by FNA if there is only one
such nodule or if there are no more than three such nodules. Only the largest nodule and
nodules with suspect characteristics on ultrasound will be controlled by FNA if there are
more than three nodules exceeding 10 mm in diameter. The procedure adopted depends on the
individual nodule. Decisions concerning surgery are based on the most severe diagnosis
obtained if several nodules are assessed.

For each nodule subjected to FNA, a complete radiological description will be written,
regardless of the time-point at which the investigation is carried out (T0, T6, T12 or T18).
For patients seen on several occasions during the study, any changes in one or several
nodules observed on ultrasound scan will be noted.

The material collected by FNA will be deposited in liquid medium (Hologic; LBC technique).
If several nodules are examined, the material from each nodule will be placed in a separate,
clearly identified flask.

A complementary immunocytological study will be systematically carried out for all nodules
other than those considered "benign and with no radiological modifications." If there is
sufficient residual cell material, a panel of antibodies will be used, constituted from the
available antibodies against the following: HBME1, cytokeratin 19, TTF1, thyrocalcitonin,
thyroglobulin, CD3, CD20. The results will be delivered in two lots: first the cytological
and morphological results alone, according to NCI Bethesda 2008 classification criteria, and
then the immunocytochemical results, broken down into three categories (probably benign,
probably malignant and inconclusive).

Potential implication :

The aim of the study is to intend clinical, radiological, cytological and surgical feasible
recommendations for an accurate follow-up of benign single thyroid nodules or multinodular
goiter. Thyroid nodules are essentially benign lesions ; therefore the main objective is to
detect all the cancers but not to induce unnecessary surgical controls.

Inclusion Criteria:

- Patient are more than 18 years old

- Patient with a unique or several thyroid solid nodules more than 10 mm wide

- Patient who accept to be followed over 18 months

- Study Informed patient, non opposed to his/her own data analyzes

Exclusion Criteria:

- Pregnant women

- Patient with previous data of thyroid cancer

- Patient with low TSH (inferior to local norm)

- Patient refusing thyroid surgery policy/ rule

- Irresponsible patient or patient refusing to participate

- Patient with clinical or psychological state not permitting study sample

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Status nodule

Outcome Time Frame:

Inclusion, 6, 12 and 18 months

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:

ID RCB 2008-A00839-46



Start Date:

April 2010

Completion Date:

December 2012

Related Keywords:

  • Thyroid Cancer
  • Thyroid cancer
  • thyroid FNA
  • repeat FNA
  • thyroid screening
  • thyroid ultrasonography
  • FNA screening
  • Thyroid Neoplasms
  • Thyroid Diseases