NCT00615537

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 5, 2011

Status Verified

April 1, 2011

Enrollment Period

2.9 years

First QC Date

February 3, 2008

Last Update Submit

April 4, 2011

Conditions

Thyroid NoduleThyroid CancerThyroid NeoplasmsNodular Goiter

Keywords

Thyroid NoduleThyroid CancerLaser AblationLITTNodular GoiterThyroid Mass

Outcome Measures

Primary Outcomes (1)

  • The primary goal of this study is to determine the local response of laser ablation of the treated lesion and its effect on size and vascularity. The objective measures will be based on serial US with Doppler.

    12 months

Secondary Outcomes (1)

  • To assess the effects of laser ablation on thyroid function testing. An estimate of time and cost associated with LITT procedure for treatment of soft tissue thyroid nodules.

    12 months

Interventions

Laser Ablation of Thyroid NodulePROCEDURE

Laser ablation using a laser generator, disposable fiberoptic laser fiber, cooling catheter and pump, will be performed under conscious sedation. Ultrasound will be used to localize masses. Local anesthesia will be administered both intradermally and subcutaneously. The laser applicator will be placed into the mass and laser energy will be delivered at 15W for 30-120 seconds. Real-time ultrasound monitoring of the ablation front will be used to ensure complete treatment of the target lesion. In larger masses applicators may be placed of the applicator into multiple locations. The number of locations will be determined by the treatment team, and based on lesion morphology, size, location, and accessibility.

Also known as: PhoTex15 Diode Laser, Visualase Cooled Laser Applictor System

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically documented benign thyroid nodule, or cold thyroid nodule as documented by thyroid scan.
  • Patient has been evaluated by endocrinology and endocrine surgery and has been deemed suitable candidate for procedure.
  • The patient's nodule(s) size and number must be no larger than 5cm and a maximum of 3 nodules, respectively.
  • All nodules must be greater than 1cm from the expected location of the recurrent laryngeal and vagus nerves determined under ultrasound.
  • Required initial laboratory values: T3, T4. TSH, and Thyroglobulin (for treated metastatic lymph nodes)
  • All patients must understand and sign a study-specific informed consent.

You may not qualify if:

  • Thyroid mass in contact with trachea or esophagus.
  • Uncontrolled coagulopathy or bleeding diathesis that cannot be corrected with FFP and platelets prior to procedure. (Platelets must be ≥ 70,000/ul.)
  • Aspirin and nonsteroidal anti-inflammatory medications, antiplatelet medications, or warfarin must be discontinued prior to the procedure for a time period that is appropriate given the drug half-life and the drugs known antiplatelet activity (e.g. aspirin for 7 days and ibuprofen 24 hours). Low molecular weight heparin preparations must be discontinued 24 hours prior to procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital - Department of Diagnostic Imaging Research

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Thyroid NoduleThyroid NeoplasmsGoiter, Nodular

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesGoiter

Study Officials

  • Damian Dupuy, MD

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 3, 2008

First Posted

February 14, 2008

Study Start

February 1, 2008

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 5, 2011

Record last verified: 2011-04

Locations

US(1)