Thyroid NoduleNCT00615537
Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses
A study testing Laser Ablation of Thyroid Nodule in people with Thyroid Nodule and Thyroid Cancer, run by BioTex, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Nodule, Thyroid Cancer, Thyroid Neoplasms
- What is being tested?
- Laser Ablation of Thyroid Nodule
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital - Department of Diagnostic Imaging Research
Providence, Rhode Island, 02903
About this study
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.
Read the detailed description
Thyroid nodules are a very common clinical finding, with an estimated prevalence (based on palpation) ranging from 3% to 7% among the general population. With the widespread use of ultrasound (US), clinically unapparent thyroid nodule prevalence has dramatically increased with estimates at 20% to 76% in the general population. Moreover, 20% to 48% of patients with a single palpable thyroid nodule are found to have additional nodules when investigated by US.
Laser ablation therapy offer potential for the thermal destruction of soft tissue structures. The ability to deliver large doses of energy via small flexible fiberoptics makes laser therapy ideally suited for percutaneous treatment of unwanted tissue masses.
In this study we propose to treat symptomatic soft tissue thyroid masses in the head and neck region using a new FDA-cleard laser ablation system to safely and effectively debulk the tissue and therefore improve symptoms. Real time US monitoring will be performed of the ablation front to ensure complete treatment of the target lesion. All ablated regions will be followed by US with Doppler to document changes in size and vascularity. Local effects on thyroid function for thyroid mass treatment will be measured on follow-up.
- Conditions
- Thyroid Nodule, Thyroid Cancer, Thyroid Neoplasms, Nodular Goiter
- Being tested
- Laser Ablation of Thyroid Nodule
- Keywords
- Thyroid Nodule, Thyroid Cancer, Laser Ablation, LITT, Nodular Goiter, Thyroid Mass
- Medical subject headings
- Thyroid Nodule, Thyroid Neoplasms, Goiter, Nodular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Ablation of Thyroid NoduleProcedure or surgery
Also called PhoTex15 Diode Laser, Visualase Cooled Laser Applictor System
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioTex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rhode Island Hospital
- Investigators
- Damian Dupuy, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615537
- Sponsor's protocol ID
- BTX-07-003
- Status last verified
- Apr 2011
- First submitted
- 3 Feb 2008
- Last updated
- 5 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Laser Ablation of Symptomatic Benign Thyroid Masses
- ClinicalTrials.gov ID
- NCT00615537
- Acronym / sponsor ID
- BTX-07-003
- Conditions
- Thyroid Nodule, Thyroid Cancer, Thyroid Neoplasms, Nodular Goiter
- Keywords
- Thyroid Nodule, Thyroid Cancer, Laser Ablation, LITT, Nodular Goiter, Thyroid Mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- BioTex, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Rhode Island Hospital
- Study start
- Feb 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 14 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Thyroid nodules are a very common clinical finding, with an estimated prevalence (based on palpation) ranging from 3% to 7% among the general population. With the widespread use of ultrasound (US), clinically unapparent thyroid nodule prevalence has dramatically increased with estimates at 20% to 76% in the general population. Moreover, 20% to 48% of patients with a single palpable thyroid nodule are found to have additional nodules when investigated by US.
Laser ablation therapy offer potential for the thermal destruction of soft tissue structures. The ability to deliver large doses of energy via small flexible fiberoptics makes laser therapy ideally suited for percutaneous treatment of unwanted tissue masses.
In this study we propose to treat symptomatic soft tissue thyroid masses in the head and neck region using a new FDA-cleard laser ablation system to safely and effectively debulk the tissue and therefore improve symptoms. Real time US monitoring will be performed of the ablation front to ensure complete treatment of the target lesion. All ablated regions will be followed by US with Doppler to document changes in size and vascularity. Local effects on thyroid function for thyroid mass treatment will be measured on follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Ablation of Thyroid NoduleAlso: PhoTex15 Diode Laser, Visualase Cooled Laser Applictor SystemLaser 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. | Procedure or surgery | – |
Primary outcome
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.
Time frame: 12 months
1 secondary outcome
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.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2011.
Related trials for Thyroid Nodule
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
Recruiting
Ultrasound-guided Microwave Ablation of Benign Thyroid Nodules
Thyroid Nodule (Diagnosis)
Not yet recruiting
Endotracheal Tube Versus Transcartilage Needle Electrodes for Nerve Monitoring in Thyroid Surgery
Thyroid Diseases, Recurrent Laryngeal Nerve Injury
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
Active, not recruiting
Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System
Thyroid Nodule, Thyroid Goiter
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damian Dupuy, MD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Ablation of Thyroid Nodule in people with Thyroid Nodule and Thyroid Cancer, run by BioTex, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2011.