Clinical Trials Logo

Clinical Trial Summary

This proposal is designed as a pilot study for the use of laser ablation for local control of symptomatic (e.g compressive) benign thyroid masses in 20 patients.


Clinical Trial Description

Thyroid nodules are a very common clinical finding, with an estimated prevalence (based on palpation) ranging from 3% to 7% among the general population. With the widespread use of ultrasound (US), clinically unapparent thyroid nodule prevalence has dramatically increased with estimates at 20% to 76% in the general population. Moreover, 20% to 48% of patients with a single palpable thyroid nodule are found to have additional nodules when investigated by US.

Laser ablation therapy offer potential for the thermal destruction of soft tissue structures. The ability to deliver large doses of energy via small flexible fiberoptics makes laser therapy ideally suited for percutaneous treatment of unwanted tissue masses.

In this study we propose to treat symptomatic soft tissue thyroid masses in the head and neck region using a new FDA-cleard laser ablation system to safely and effectively debulk the tissue and therefore improve symptoms. Real time US monitoring will be performed of the ablation front to ensure complete treatment of the target lesion. All ablated regions will be followed by US with Doppler to document changes in size and vascularity. Local effects on thyroid function for thyroid mass treatment will be measured on follow-up. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00615537
Study type Interventional
Source BioTex, Inc.
Contact
Status Completed
Phase N/A
Start date February 2008
Completion date January 2011

See also
  Status Clinical Trial Phase
Recruiting NCT05774535 - Prospective, Observational Study on the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
Withdrawn NCT04224792 - Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors N/A
Completed NCT01728623 - A Study of E7080 in Subjects With Advanced Thyroid Cancer Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Completed NCT02911155 - Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
Recruiting NCT05025046 - NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
Not yet recruiting NCT03978351 - The Role of Midkine in Diagnosis of Thyroid Cancer
Completed NCT02658513 - Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Completed NCT02375451 - Effect of Childhood Radioiodine Therapy on Salivary Function N/A
Withdrawn NCT01994200 - Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients Phase 1/Phase 2
Terminated NCT01403324 - Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer N/A
Completed NCT00970359 - Reacquisition of Radioactive Iodine (RAI) Uptake of RAI-Refractory Metastatic Thyroid Cancers by Pretreatment With the Selective MEK Inhibitor AZD6244 N/A
Completed NCT00439478 - Dental Safety Profile of High-Dose Radioiodine Therapy Phase 4
Completed NCT00223158 - Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer N/A
Active, not recruiting NCT04544111 - PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer Phase 2
Completed NCT04876287 - Salivary dysfuncTion After Radioiodine Treatment
Recruiting NCT06073223 - Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer N/A
Recruiting NCT06037174 - Comparison of Quality of Life in Patients With Differentiated Thyroid Carcinoma Undergoing Different Surgery
Recruiting NCT04952493 - Anlotinib or Penpulimab in Combination With RAI for DTC Phase 2