NCT00103155

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2005

Completed
Last Updated

September 20, 2013

Status Verified

August 1, 2005

First QC Date

February 7, 2005

Last Update Submit

September 19, 2013

Conditions

Head and Neck Cancer

Keywords

stage I papillary thyroid cancer

Outcome Measures

Primary Outcomes (1)

  • Frequency of radiofrequency ablation-associated complications at 2 weeks

Secondary Outcomes (1)

  • Amount of tumor destruction at 2 weeks

Interventions

conventional surgeryPROCEDURE
radiofrequency ablationPROCEDURE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

UCSF Comprehensive Cancer Center

San Francisco, California, 94143-1674, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsThyroid Cancer, Papillary

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsAdenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeThyroid NeoplasmsEndocrine Gland NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Electron Kebebew, MD

    University of California, San Francisco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2005

First Posted

February 8, 2005

Study Start

September 1, 2004

Last Updated

September 20, 2013

Record last verified: 2005-08

Locations

US(1)