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Radiofrequency Ablation in Treating Patients Who Are Undergoing Surgery for Thyroid Cancer

Radiofrequency Ablation for Low Risk Papillary Thyroid Cancer: A Pilot Study

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00103155
Enrollment
Unknown
Registered
2005-02-08
Start date
2004-09-30
Completion date
Unknown
Last updated
2013-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

stage I papillary thyroid cancer

Brief summary

RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Ultrasound-guided radiofrequency ablation may be effective treatment for thyroid cancer. PURPOSE: This phase I trial is studying the side effects of radiofrequency ablation in treating patients who are undergoing surgery for thyroid cancer.

Detailed description

OBJECTIVES: * Determine the frequency of complications associated with radiofrequency ablation (RFA) in patients with low-risk papillary thyroid cancer undergoing thyroidectomy. * Determine the utility of RFA as a treatment option for these patients. OUTLINE: This is a pilot study. An electrosurgical probe is placed by ultrasound guidance into the center of the thyroid tumor. Patients undergo radiofrequency ablation directly to the tumor until the target temperature is reached\* for 5 minutes. Patients then undergo standard thyroidectomy. NOTE: \*Takes approximately 15-30 minutes to reach target temperature. After completion of study treatment, patients are followed at day 1, between days 14-21, and then periodically as deemed necessary. PROJECTED ACCRUAL: A total of 15-40 patients will be accrued for this study.

Interventions

PROCEDUREconventional surgery
PROCEDUREradiofrequency ablation

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Cytologically confirmed papillary thyroid cancer by fine needle aspiration * Low-risk disease * No poorly differentiated cytology * Intrathyroidal tumor * Located within the anterior two-thirds of the thyroid lobe * Tumor not adjacent to the trachea by neck ultrasound * Tumor ≤ 1.5 cm by neck ultrasound * Requires thyroidectomy * No cervical lymphadenopathy * No multicentric tumors by neck ultrasound * No evidence of lymph node metastasis PATIENT CHARACTERISTICS: Age * Over 21 Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

Design outcomes

Primary

MeasureTime frame
Frequency of radiofrequency ablation-associated complications at 2 weeks

Secondary

MeasureTime frame
Amount of tumor destruction at 2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026