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Laser Therapy of Benign Thyroid Nodules

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Odense University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Benign Solitary Solid Cystic Thyroid Nodules Procedure: Interstitial laser photocoagulation Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Interstitial Laser Photocoagulation on Benign Thyroid Nodules
Study Start Date : January 2001
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases




Primary Outcome Measures :
  1. 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.
  2. 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.
  3. 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.


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00150150     History of Changes
Other Study ID Numbers: 017
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: March 27, 2007
Last Verified: March 2007

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