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Laser Therapy of Benign Thyroid Nodules

Primary Purpose

Benign Solitary Solid, Cystic Thyroid Nodules

Status
Unknown status
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Interstitial laser photocoagulation
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Solitary Solid focused on measuring Interventional ultrasound, interstitial laser theraphy, tumor ablation, nodule reduction, adverse effects, patient satesfaction

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Endocrinology, Odense University Hospital

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
September 6, 2005
Last Updated
March 26, 2007
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00150150
Brief Title
Laser Therapy of Benign Thyroid Nodules
Official Title
Ultrasound Guided Interstitial Laser Photocoagulation on Benign Thyroid Nodules
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Odense University Hospital

4. Oversight

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Solitary Solid, Cystic Thyroid Nodules
Keywords
Interventional ultrasound, interstitial laser theraphy, tumor ablation, nodule reduction, adverse effects, patient satesfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Interstitial laser photocoagulation
Primary Outcome Measure Information:
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helle Døssing, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology, Odense University Hospital
City
Odense
State/Province
Funen
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

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Laser Therapy of Benign Thyroid Nodules

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