Feasibility of Radiofrequency Ablation in the Management of Papillary Thyroid Cancer Under Ultra-Sound Guidance.
Recruitment status was Not yet recruiting
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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 |
- 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.
- Patients will be followed-up accordingly for any complications.
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | November 2008 |
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 |
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| Contact: Tarik Farrag, M.D | 410-955-3628 | tfarrag1@jhmi.edu |
| United States, Maryland | |
| Johns Hopkins University, School of Medicine | Not yet recruiting |
| Baltimore, Maryland, United States, 21287 | |
| 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 Endocrine Gland Neoplasms Neoplasms by Site |
Neoplasms Head and Neck Neoplasms Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013