- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00150150
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:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Funen
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Odense, Funen, Denmark, 5000
- Department of Endocrinology, Odense University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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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.
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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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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Helle Døssing, MD, Odense University Hospital
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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