Overview

This trial is active, not recruiting.

Conditions benign solitary solid, cystic thyroid nodules
Treatment interstitial laser photocoagulation
Phase phase 3
Sponsor Odense University Hospital
Start date January 2001
End date March 2006
Trial size 70 participants
Trial identifier NCT00150150, 017

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
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.
time frame:
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.
time frame:
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.
time frame:

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

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

Additional Information

Official title Ultrasound Guided Interstitial Laser Photocoagulation on Benign Thyroid Nodules
Principal investigator Helle Døssing, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2007.
Information provided to ClinicalTrials.gov by Odense University Hospital.