Laser Therapy of Benign Thyroid Nodules - Full Text View

Sponsor:	Odense University Hospital
Information provided by:	Odense University Hospital
ClinicalTrials.gov Identifier:	NCT00150150

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:

Randomized study of interstitial laser photocoagulation for benign solitary cold thyroid nodules – one versus two or three treatments
Randomized study of interstitial laser photocoagulation for benign solitary autonomous thyroid nodules – 131I versus laser ablation
Interstitial laser photocoagulation for benign thyroid cystadenomas. – a feasibility study.

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

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:

MedlinePlus related topics: Cancer Thyroid Diseases Ultrasound

Drug Information available for: Thyroid

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 February 09, 2012