Benign Solitary Solid Clinical Trial
Official title:
Ultrasound Guided Interstitial Laser Photocoagulation on Benign Thyroid Nodules
| Verified date | March 2007 |
| Source | Odense University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: National Board of Health |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 70 |
| Est. completion date | March 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Department of Endocrinology, Odense University Hospital | Odense | Funen |
| Lead Sponsor | Collaborator |
|---|---|
| Odense University Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | |||
| Primary | 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. | |||
| Primary | 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. |