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Laser Therapy of Benign Thyroid Nodules

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Odense University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00150150
First received: September 6, 2005
Last updated: March 26, 2007
Last verified: March 2007

September 6, 2005
March 26, 2007
January 2001
Not Provided
  • 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 ClinicalTrials.gov 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
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
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00150150
017
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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