Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results

NCT00858104 | Completed Phase 4 DMC

• 1 other identifier: IALT-07
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

Thyroid nodule pathologies occur frequently and represent a clinical issue for the endocrinologists, surgeons, nuclear physicians as well as the general practitioners. The incidence of this pathology has been further highlighted by the introduction of the ultrasound examination into the clinical practice as 20% with impalpable thyroid nodules is now detected through ultrasound. The majority of nodules are benign and characterized by slow growth, and therefore treated with suppressive doses of levothyroxine. Long-term levothyroxine treatment has, however, several well-known side effects and limitations. During the last years, number of controlled studies have demonstrated that ultrasound guided percutaneous laser treatment (PLA) is able to reach the target lesion within the thyroid with a high level of precision, and to destroy the thyroid tissue in a predictable and repeatable fashion, without side effects. Aim of the study:

1. 1.to assess 1-year and 3-year effect of laser ablation therapy on the volume of benign thyroid nodules and on nodule-related symptoms, and to compare these effects with findings in control group without active therapy;
2. 2.to assess the eventual re-occurence of thyroid lesions (observed after other types of ablation treatment, like percutaneous ethanol injection) during a 3-year follow-up;
3. 3.to demonstrate reproducibility of results within different environments and under different operators;
4. 4.to validate eventual presence of major or minor side effects.

Conditions

Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

• 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)

  3 years

Secondary Outcomes (1)

• Assessment of short-term and long-term PLA safety, tolerability and reproducibility.

  3 years

Study Arms (2)

1

ACTIVE COMPARATOR

Laser thermal ablation

Procedure: Percutaneous Laser Ablation

2

NO INTERVENTION

Follow-up

Interventions

Percutaneous Laser Ablation PROCEDURE

Single session with standardized approach: Two fibers, up to 2 laser emissions; nodule volume up to 10 ml are treated by 800 Joules /ml and above 10 ml by 600 Joules/ml.The treatment is performed under local anesthesia and with diazepam sedation.

Also known as: Arcispedale S. Maria Nuova is using commercially available system EchoLaser XVG, (Integrated Ultrasound-Laser, Elesta, Italy). Other centers are using commercially available, systems MyLab70XV (Ultrasound, Esaote, Italy) and Smart1064 BS (Nd:Yag Laser,, DEKA, Italy). Disposable Fiber Optic devices : Bare Fiber PLA THY 2111, Bare Fiber PLA S, (Asclepion Laser Technologies GmbH, Germany).

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• Hyperfunctioning lesion (99mTc scintigraph);
• Autoimmune thyreopathy or elevation of autoantibodies;
• Active anticoagulant treatment or antiaggregation treatment.

Sponsors & Collaborators

• Elesta S.R.L.: lead

Study Sites (4)

Azienda Ospedaliera di Perugia - Osp. S.Maria della Misericordia

Perugia, Perugia, 06126, Italy

Location

Azienda Ospedaliero-Universitaria di Pisa - Presidio di Cisanello

Pisa, Pisa, 56124, Italy

Location

Arcispedale S. Maria Nuova

Reggio Emilia, Reggio Emilia, 42100, Italy

Location

Ospedale Regina Apostolorum

Albano Laziale, Roma, 00041, Italy

Location

Related Publications (6)

• Pacella CM, Bizzarri G, Guglielmi R, Anelli V, Bianchini A, Crescenzi A, Pacella S, Papini E. Thyroid tissue: US-guided percutaneous interstitial laser ablation-a feasibility study. Radiology. 2000 Dec;217(3):673-7. doi: 10.1148/radiology.217.3.r00dc09673.

  PMID: 11110927 BACKGROUND

• Dossing H, Bennedbaek FN, Karstrup S, Hegedus L. Benign solitary solid cold thyroid nodules: US-guided interstitial laser photocoagulation--initial experience. Radiology. 2002 Oct;225(1):53-7. doi: 10.1148/radiol.2251011042.

  PMID: 12354983 BACKGROUND

• Pacella CM, Bizzarri G, Spiezia S, Bianchini A, Guglielmi R, Crescenzi A, Pacella S, Toscano V, Papini E. Thyroid tissue: US-guided percutaneous laser thermal ablation. Radiology. 2004 Jul;232(1):272-80. doi: 10.1148/radiol.2321021368. Epub 2004 May 20.

  PMID: 15155898 BACKGROUND

• Dossing H, Bennedbaek FN, Hegedus L. Effect of ultrasound-guided interstitial laser photocoagulation on benign solitary solid cold thyroid nodules - a randomised study. Eur J Endocrinol. 2005 Mar;152(3):341-5. doi: 10.1530/eje.1.01865.

  PMID: 15757849 BACKGROUND

• Papini E, Guglielmi R, Bizzarri G, Graziano F, Bianchini A, Brufani C, Pacella S, Valle D, Pacella CM. Treatment of benign cold thyroid nodules: a randomized clinical trial of percutaneous laser ablation versus levothyroxine therapy or follow-up. Thyroid. 2007 Mar;17(3):229-35. doi: 10.1089/thy.2006.0204.

  PMID: 17381356 BACKGROUND

• Papini E, Rago T, Gambelunghe G, Valcavi R, Bizzarri G, Vitti P, De Feo P, Riganti F, Misischi I, Di Stasio E, Pacella CM. Long-term efficacy of ultrasound-guided laser ablation for benign solid thyroid nodules. Results of a three-year multicenter prospective randomized trial. J Clin Endocrinol Metab. 2014 Oct;99(10):3653-9. doi: 10.1210/jc.2014-1826. Epub 2014 Jul 22.

  PMID: 25050903 DERIVED

MeSH Terms

Conditions

Thyroid Nodule

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 9, 2009
• Study Start: November 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2013
• Last Updated: May 26, 2014

Record last verified: 2014-05

Locations

IT (4)