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Thyroid NodulePhase 4NCT00858104

Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results

A Phase 4 study testing Percutaneous Laser Ablation in people with Thyroid Nodule, run by Elesta S.R.L. at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Nodule
What is being tested?
Percutaneous Laser Ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
4 sitesItaly
Study dates
Nov 2008to May 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • Ospedale Regina Apostolorum

    Albano Laziale, Roma, 00041

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

    Perugia, Perugia, 06126

  • Azienda Ospedaliero-Universitaria di Pisa - Presidio di Cisanello

    Pisa, Pisa, 56124

  • Arcispedale S. Maria Nuova

    Reggio Emilia, Reggio Emilia, 42100

Other trials in Italy

About this study

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

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.

Read more

Aim of the study:

  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. 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. to demonstrate reproducibility of results within different environments and under different operators;
  4. to validate eventual presence of major or minor side effects.

To this aim we shall randomized 200 patients either for PLA (100 pts) or standard follow-up. Patients will be recruited, treated and followed in 4 italian centers (Ospedale Regina Apostolorum - Roma, Arcispedale S. Maria Nuova - Reggio Emilia, Ospedale S. Maria della Misericordia - Perugia, Ospedale di Cisanello - Pisa) by physicians with experience in PLA.The scientific coordinator of this multicentre study is dr. Claudio Maurizio Pacella.

Conditions
Thyroid Nodule
Being tested
Percutaneous Laser Ablation
Medical subject headings
Thyroid Nodule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Laser AblationProcedure or surgery

    Also called 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

    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.

Study groups in NCT00858104
Study groupRoleWhat they receive
1Active comparatorLaser thermal ablation
Receives: Procedure: Percutaneous Laser Ablation
2No interventionFollow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3 years

Secondary outcomes (1)

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2009 (estimated)
  2. Study startNov 2008
  3. Primary completionMar 2010
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00858104
Sponsor's protocol ID
IALT-07
Status last verified
May 2014
First submitted
6 Mar 2009
Last updated
26 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11110927

  • 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.

    PubMed 12354983

  • 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.

    PubMed 15155898

  • 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.

    PubMed 15757849

  • 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.

    PubMed 17381356

  • 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.

    PubMed 25050903

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Percutaneous Laser Ablation in people with Thyroid Nodule, run by Elesta S.R.L. at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00858104, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2014.

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