Laser Therapy of Benign Thyroid Nodules

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00150150
Recruitment Status : Unknown
Verified March 2007 by Odense University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 8, 2005
Last Update Posted : March 27, 2007
Information provided by:
Odense University Hospital

September 6, 2005
September 8, 2005
March 27, 2007
January 2001
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  • To evaluate the efficacy and feasibility repeated ILP treatments in a prospective randomised study where the nodule and thyroid volume are measured 1, 3, 6 and 12 months after the ILP.
  • In the study of patients with a cystadenoma the measures will be done like wise, but also the recurrence of the cystic part will be measured.
  • Patients with an autonomous functioning nodule measurements of thyroid function are performed 1,2, 3, 6, 9 and 12 months after the ILP or 131I therapy.
Same as current
Complete list of historical versions of study NCT00150150 on Archive Site
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Laser Therapy of Benign Thyroid Nodules
Ultrasound Guided Interstitial Laser Photocoagulation on Benign Thyroid Nodules

Nodular goitre is common in the general population and less than 5% of the patients who undergo surgery for solitary thyroid nodules have cancer, in absence of clinical suspicion. Nodules left untreated seem to have a slight growth potential in borderline iodine-deficient areas. Interstitial laser photo-coagulation (ILP) is a procedure for local hyperthermia and photocoagulation, allowing minimally invasive treatment of benign tumors, including thyroid nodules. The aim of these studies are to evaluate if ILP will be useful in reducing the volume of the benign thyroid nodule and thyroid function will be unaffected in euthyroid patients, and normalized in pretoxic- and toxic thyroid nodules. The investigations are listed below:

  1. Randomized study of interstitial laser photocoagulation for benign solitary cold thyroid nodules – one versus two or three treatments
  2. Randomized study of interstitial laser photocoagulation for benign solitary autonomous thyroid nodules – 131I versus laser ablation
  3. Interstitial laser photocoagulation for benign thyroid cystadenomas. – a feasibility study.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Benign Solitary Solid
  • Cystic Thyroid Nodules
Procedure: Interstitial laser photocoagulation
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
March 2006
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Inclusion Criteria:

  • Patients with a solitary solid thyroid nodule confirmed by ultrasonography
  • Patients with a solitary cystadenoma (cystic part more than 2 mL) confirmed by ultrasonography
  • Patients with an autonomous functioning thyroid nodule.

Exclusion Criteria:

  • No family history of thyroid cancer
  • Prior radiation towards the neck
  • Fine needle biopsy without valid diagnostic criteria for benign thyroid disease
  • Nodules larger than 4 cm (largest diameter)
  • Suspicion of malignancy
  • Increased serum calcitonin
  • Pregnancy or lactation
  • Alcohol, medicine or drug abuse
  • No safe contraception
  • Physical or psychic condition that hinders corporation
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Odense University Hospital
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Principal Investigator: Helle Døssing, MD Odense University Hospital
Odense University Hospital
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP