Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-30 @ 12:55 AM
Study NCT ID:
NCT00150150
Status:
UNKNOWN
Last Update Posted:
2007-03-27
First Post:
2005-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Therapy of Benign Thyroid Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2006-03'}, 'lastUpdateSubmitDate': '2007-03-26', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2007-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}, {'measure': '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.'}, {'measure': '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.'}]}, 'conditionsModule': {'keywords': ['Interventional ultrasound', 'interstitial laser theraphy', 'tumor ablation', 'nodule reduction', 'adverse effects', 'patient satesfaction'], 'conditions': ['Benign Solitary Solid', 'Cystic Thyroid Nodules']}, 'descriptionModule': {'briefSummary': '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:\n\n1. Randomized study of interstitial laser photocoagulation for benign solitary cold thyroid nodules - one versus two or three treatments\n2. Randomized study of interstitial laser photocoagulation for benign solitary autonomous thyroid nodules - 131I versus laser ablation\n3. Interstitial laser photocoagulation for benign thyroid cystadenomas. - a feasibility study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a solitary solid thyroid nodule confirmed by ultrasonography\n* Patients with a solitary cystadenoma (cystic part more than 2 mL) confirmed by ultrasonography\n* Patients with an autonomous functioning thyroid nodule.\n\nExclusion Criteria:\n\n* No family history of thyroid cancer\n* Prior radiation towards the neck\n* Fine needle biopsy without valid diagnostic criteria for benign thyroid disease\n* Nodules larger than 4 cm (largest diameter)\n* Suspicion of malignancy\n* Increased serum calcitonin\n* Pregnancy or lactation\n* Alcohol, medicine or drug abuse\n* No safe contraception\n* Physical or psychic condition that hinders corporation'}, 'identificationModule': {'nctId': 'NCT00150150', 'briefTitle': 'Laser Therapy of Benign Thyroid Nodules', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Ultrasound Guided Interstitial Laser Photocoagulation on Benign Thyroid Nodules', 'orgStudyIdInfo': {'id': '017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Interstitial laser photocoagulation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'state': 'Funen', 'country': 'Denmark', 'facility': 'Department of Endocrinology, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Helle Døssing, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}}}}