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Ultrasound Guided Interstitial Laser Photocoagulation on Benign Thyroid Nodules


Phase 3
20 Years
70 Years
Open (Enrolling)
Both
Benign Solitary Solid, Cystic Thyroid Nodules

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Trial Information

Ultrasound Guided Interstitial Laser Photocoagulation on Benign Thyroid Nodules


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Principal Investigator

Helle Døssing, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Odense University Hospital

Authority:

Denmark: National Board of Health

Study ID:

017

NCT ID:

NCT00150150

Start Date:

January 2001

Completion Date:

March 2006

Related Keywords:

  • Benign Solitary Solid
  • Cystic Thyroid Nodules
  • Interventional ultrasound
  • interstitial laser theraphy
  • tumor ablation
  • nodule reduction
  • adverse effects
  • patient satesfaction
  • Thyroid Diseases
  • Thyroid Nodule

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