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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
History of Changes
  Purpose

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.

Condition Intervention Phase
Benign Solitary Solid
Cystic Thyroid Nodules
 Procedure: Interstitial laser photocoagulation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrasound Guided Interstitial Laser Photocoagulation on Benign Thyroid Nodules

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 70
Study Start Date: January 2001
Estimated Study Completion Date: March 2006
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150150

Locations
Denmark
Department of Endocrinology, Odense University Hospital
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Helle Døssing, MD Odense University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00150150     History of Changes
Other Study ID Numbers: 017
Study First Received: September 6, 2005
Last Updated: March 26, 2007
Health Authority: Denmark: National Board of Health

Keywords provided by Odense University Hospital:
Interventional ultrasound
interstitial laser theraphy
tumor ablation
 nodule reduction
adverse effects
patient satesfaction

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Nodule
Endocrine System Diseases
Thyroid Neoplasms
 Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on October 16, 2012