Feasibility of Radiofrequency Ablation in the Management of Papillary Thyroid Cancer Under Ultra-Sound Guidance.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Johns Hopkins University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00381225
First received: September 26, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

To study the feasibility of Radiofrequency ablation (RFA) via ultrasound guidance in the treatment of papillary thyroid cancer (PTC).


Condition Intervention
Papillary Thyroid Cancer
Procedure: Ultra-sound guided radio-frequency ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Radio-Frequency Ablation in the Management of Papillary Thyroid Cancer Under Ultra-Sound Guidance

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • After the procedure, each patient will have his/her routine post-operative care and the follow up visits for surgery, without additional specified visits or procedures for the study
  • Patients will be examined for any possible complications at the time of surgery.

Secondary Outcome Measures:
  • Patients will be followed-up accordingly for any complications.

Estimated Enrollment: 20
Study Start Date: November 2006
Estimated Study Completion Date: November 2008
Detailed Description:

Around 23,000 cases of thyroid cancer are discovered annually in the US, and PTC accounts for 70-75% of those cases. The conventional treatment consists mainly of surgical resection, in the form of lobectomy with/without isthmusectomy, or total thyroidectomy, making it one of the most commonly performed procedures. It has high costs, and exposes the patients to morbidity of surgery and anesthesia. PTC tends to be indolent with a 90% cure rate and controversy exists regarding extent of treatment.

Percutaneous image-guided RFA has received increasing attention as a promising minimally invasive technique for the treatment of focal malignant disease. It permits the in situ destruction of tumors without necessitating their surgical excision.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-90 years old
  • Patients with low risk well-differentiated PTC, diagnosed by US guided FNA, and whose management decision is total thyroidectomy.
  • Patients with only one dominant malignant nodule will be included in the study.
  • Patients with size of their thyroid nodule ranging only between 1-4cm in diameter will be included in the study.
  • Patients with nodules located only in between the mid and lower pole of the thyroid gland will be included in the study.

Exclusion Criteria:

  • When the patient does not meet the inclusion criteria.
  • When the patient has a contra-indication of surgery or anesthesia.
  • If the patient refuses involvement in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381225

Contacts
Contact: Tarik Farrag, M.D 410-955-3628 tfarrag1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University, School of Medicine Not yet recruiting
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Kieran Murphy, M.D Johns Hopkins University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00381225     History of Changes
Other Study ID Numbers: NA_00002641
Study First Received: September 26, 2006
Last Updated: September 26, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
radio-frequency
ablation
ultra-sound
guidance
papillary
thyroid
cancer

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Carcinoma
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 22, 2014