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Multicentric Randomized Controlled Study of Percutaneous Laser Ablation Versus Follow Up in Benign Thyroid Nodules. Long Term Results


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Thyroid Nodule

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Trial Information

Multicentric Randomized Controlled Study of Percutaneous Laser Ablation Versus Follow Up in Benign Thyroid Nodules. Long Term Results


Inclusion Criteria:



- The presence of a single nodule or dominating nodule;

- A solid or mixed echo-structure with less than 20% fluid volume;

- A lesion volume between 5 and 18 ml (greatest diameter > 3.0 cm and <= 4 cm);

- Thyroid hormone and TSH serum levels within the normalcy value;

- 2 cytologically negative examinations for suspected neoplasia (British Thyroid
Association, Second class THY)within the last six months;

- Calcitonin values within the normalacy value;

- Anticoagulant treatment suspension and antiaggregation treatment suspended for at
least 72 hours.

Exclusion Criteria:

- Hyperfunctioning lesion (99mTc scintigraph);

- Autoimmune thyreopathy or elevation of autoantibodies;

- Active anticoagulant treatment or antiaggregation treatment.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Short- (1-year) and long- (3-year) term evolution of the thyroid nodules volume and symptoms after the treatment vs. simple clinical observation.(Strong Endpoint: %nodules with greater than 50% base volume reduction and %patients free of symptoms)

Outcome Time Frame:

3 years

Safety Issue:

Yes

Authority:

Italy: Ethics Committee

Study ID:

IALT-07

NCT ID:

NCT00858104

Start Date:

November 2008

Completion Date:

December 2012

Related Keywords:

  • Thyroid Nodule
  • Thyroid Diseases
  • Thyroid Nodule

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