Autonomous Hyperfunctioning Thyroid NodulesEarly Phase 1NCT02169687
High Intensity Focused Ultrasound Device in Patients With Autonomous Hyperfunctioning Thyroid Nodules
A Early Phase 1 study testing HIFU in people with Autonomous Hyperfunctioning Thyroid Nodules, run by Theraclion at 1 site in France.
Trial summary
The purpose of this study is to assess the efficacy and safety of High Intensity Focalized Ultrasound (HIFU) in the treatment for toxic Thyroids nodules Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autonomous Hyperfunctioning Thyroid Nodules
- What is being tested?
- HIFU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2006to Oct 2007
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient, aged at least 18 years.
- Patient presenting with at least one autonomous hyperfunctioning thyroid nodule
- TSH 0,1 mU/ml
- Hyperfunctioning at thyroid scintigraphy with partial or total extinction of parenchyma
- Targeted nodules visible with ultrasonography
- Volume to be treated 15 cc
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- Targeted area located at least at 2 mm from the trachea, the esophagus, and the carotid artery.
- Composition of the targeted nodule: no more than 75% cystic.
- Absence of abnormality at laryngoscopy in recurrent nerves
- Voluntary consent (patient or legal guardian) to participate in the study, following a full explanation of the nature and purpose of the study, by signing the Informed Consent document at the eligibility assessment visit
- Patients for whom iodine therapy is contra-indicated or unfeasible and surgery is contra-indicated or refused
- Patients refusing iodine therapy
- Willingness and availability to return for all required follow-up visits and to undergo all required study procedures.
- Patient affiliated to the French Health Insurance System
Who cannot join
- For the targeted nodule(s): presence of signs evidencing a nodule malignancy (compression or curvature of the surrounding organs, positive or suspicious previous FNAB).
- Suspicious cervical lymph nodes at US
- > 75% Cystic nodule
- Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment
- Pregnant or lactating woman. Female patient of childbearing age will be screened for pregnancy prior to enrollment in the study and will be included only if having a suitable contraception method.
- Known latex or lidocaine hypersensitivity
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- History of neck irradiation or subtotal thyroidectomy
- Non controlled evolutive cardiothyreosis
- Patients treated with antithyroid medications within the month before the pre-treatment visit
- Subjects whose concurrent illnesses, disability, or geographical residence would hamper regular attendance at required study visits
- Patients who have received any investigational drug or device within the last 30 days and/or patients who are currently participating in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot, Monocentric, Non-comparative Study of the Effectiveness and Safety of High Intensity Focused Ultrasound Device in Patients With Autonomous Hyperfunctioning Thyroid Nodules
The purpose of this study is to assess the efficacy and safety of High Intensity Focalized Ultrasound (HIFU) in the treatment for toxic Thyroids nodules
Read the detailed description
Hyperthyroidism is defined by a decrease in thyrotropin (TSH) level associated with elevated or normal free T4 and T3 (subclinical hyperthyroidism). The most frequent etiology in the older population is toxic adenoma or toxic multinodular goiter. Several studies have demonstrated that such hyperthyroid status was associated with an increase in cardiac arrhythmias (atrial fibrillation) and an increase in cardiovascular mortality. Nevertheless, the management of patients presenting with subclinical hyperthyroidism remains controversial.
Surgery is indicated in case of large toxic adenomas especially in young patients. In European countries, radioiodine treatment is indicated in older patients, especially presenting with cardiothyreosis or when surgery is contraindicated. Radioiodine is a simple, cost-effective, and safe procedure in the treatment of autonomously hyperfunctioning thyroid nodule. In a prospective study [Nygaard, 1999], there was a 45% decrease in the total thyroid volume within 3 months after radio-iodine treatment, and 75% of patients with no previous anti-thyroid drug treatment normalized for thyroid function within 3 months. In another recently published prospective study [Endorgan, 2004], there was a decrease in hot nodules volume assessed by US of 28.8% 3 months, 46.2% 6 months and 54% 12 months after radioiodine treatment, and 66.7% of patients were euthyroid at 3 months, 71.8% at 6 months, 76.9% at 12 months. The AACE guidelines for the diagnosis and management of thyroid nodules [Feld, 1996] recommend that all patients with toxic autonomous thyroid nodules require treatment and remind that radioactive iodine is the treatment of choice for most patients with toxic nodules. Nevertheless, at the present time there are no published data that demonstrate the effectiveness of radioiodine treatment on the prevention of cardiac complications in case of subclinical hyperthyroidism. When radioiodine treatment is proposed, physicians must follow regulations and policies on 131I in Europe and US. The European Union recently adopted the main international commission on radiological protection (ICRP) recommendations on radiation protection. Such regulation may raise a number of practical problems for 131I treated patients. With the exception of a few countries as Germany and Switzerland, there often is no legislation defining the maximal dose of radioiodine that can be administered on an ambulatory basis. Policies and recommendations have been proposed to reduce the radiation hazards for the public or the family leaving around the radioiodine treated patients.
Therefore, because of these radioprotection recommendations, and because of contraindication to surgery and to radioiodine in some cases, an alternative treatment for toxic nodular nodules, HIFU, may be suggested.
The aim of the study is to assess the efficacy and safety of HIFU treatment for autonomous hyperfunctioning thyroid nodules. The main objective of the study is to assess the rate of patients with TSH normalization (or increase). US changes of treated nodules, especially the nodule volume, will be evaluated.
- Being tested
- HIFU
- Keywords
- Thyroid, HIFU, hyperfunctioning, autonomous
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFUDevice
High Intensity focalized Ultrasounds
| Study group | Role | What they receive |
|---|---|---|
| Hifu | Experimental | Not described Receives: Device: HIFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patient with TSH normalization / increase
Measured: 3 months
Secondary outcomes (4)
Number of patients with TSH normalization / increase
Measured: 3 weeks, 6 months, 12 months
Changes of FT3 and FT4
Measured: D3, D14, 6 weeks, M3, M6, M12
Change in the volume nodule
Measured: 6 weeks, M3, M6 and M12
Number of adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2006
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: Protocol's modifications requested by IRB weren't feasible to continue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomous Hyperfunctioning Thyroid NodulesStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theraclion
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere, Hôpital Saint Louis Paris
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169687
- Sponsor's protocol ID
- HIFU/F/02.01/Protocol V0
- Status last verified
- Jun 2014
- First submitted
- 5 May 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Monocentric, Non-comparative Study of the Effectiveness and Safety of High Intensity Focused Ultrasound Device in Patients With Autonomous Hyperfunctioning Thyroid Nodules
- ClinicalTrials.gov ID
- NCT02169687
- Acronym / sponsor ID
- HIFU/F/02.01/Protocol V0
- Keywords
- Thyroid, HIFU, hyperfunctioning, autonomous
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol's modifications requested by IRB weren't feasible to continue the study
- Enrolment
- 2 participants (actual)
- Lead sponsor
- TheraclionIndustry (pharma, biotech, devices)
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere, Hôpital Saint Louis Paris
- Study start
- Jun 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 23 Jun 2014 (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.
The purpose of this study is to assess the efficacy and safety of High Intensity Focalized Ultrasound (HIFU) in the treatment for toxic Thyroids nodules
Detailed description
Hyperthyroidism is defined by a decrease in thyrotropin (TSH) level associated with elevated or normal free T4 and T3 (subclinical hyperthyroidism). The most frequent etiology in the older population is toxic adenoma or toxic multinodular goiter. Several studies have demonstrated that such hyperthyroid status was associated with an increase in cardiac arrhythmias (atrial fibrillation) and an increase in cardiovascular mortality. Nevertheless, the management of patients presenting with subclinical hyperthyroidism remains controversial.
Surgery is indicated in case of large toxic adenomas especially in young patients. In European countries, radioiodine treatment is indicated in older patients, especially presenting with cardiothyreosis or when surgery is contraindicated. Radioiodine is a simple, cost-effective, and safe procedure in the treatment of autonomously hyperfunctioning thyroid nodule. In a prospective study [Nygaard, 1999], there was a 45% decrease in the total thyroid volume within 3 months after radio-iodine treatment, and 75% of patients with no previous anti-thyroid drug treatment normalized for thyroid function within 3 months. In another recently published prospective study [Endorgan, 2004], there was a decrease in hot nodules volume assessed by US of 28.8% 3 months, 46.2% 6 months and 54% 12 months after radioiodine treatment, and 66.7% of patients were euthyroid at 3 months, 71.8% at 6 months, 76.9% at 12 months. The AACE guidelines for the diagnosis and management of thyroid nodules [Feld, 1996] recommend that all patients with toxic autonomous thyroid nodules require treatment and remind that radioactive iodine is the treatment of choice for most patients with toxic nodules. Nevertheless, at the present time there are no published data that demonstrate the effectiveness of radioiodine treatment on the prevention of cardiac complications in case of subclinical hyperthyroidism. When radioiodine treatment is proposed, physicians must follow regulations and policies on 131I in Europe and US. The European Union recently adopted the main international commission on radiological protection (ICRP) recommendations on radiation protection. Such regulation may raise a number of practical problems for 131I treated patients. With the exception of a few countries as Germany and Switzerland, there often is no legislation defining the maximal dose of radioiodine that can be administered on an ambulatory basis. Policies and recommendations have been proposed to reduce the radiation hazards for the public or the family leaving around the radioiodine treated patients.
Therefore, because of these radioprotection recommendations, and because of contraindication to surgery and to radioiodine in some cases, an alternative treatment for toxic nodular nodules, HIFU, may be suggested.
The aim of the study is to assess the efficacy and safety of HIFU treatment for autonomous hyperfunctioning thyroid nodules. The main objective of the study is to assess the rate of patients with TSH normalization (or increase). US changes of treated nodules, especially the nodule volume, will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hifu | Experimental | Device: HIFU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female patient, aged at least 18 years.
- Patient presenting with at least one autonomous hyperfunctioning thyroid nodule
- Targeted nodules visible with ultrasonography
- Volume to be treated 15 cc
- Targeted area located at least at 2 mm from the trachea, the esophagus, and the carotid artery.
Key exclusion criteria (11 listed)
- For the targeted nodule(s): presence of signs evidencing a nodule malignancy (compression or curvature of the surrounding organs, positive or suspicious previous FNAB).
- Suspicious cervical lymph nodes at US
- > 75% Cystic nodule
- Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment
- Pregnant or lactating woman. Female patient of childbearing age will be screened for pregnancy prior to enrollment in the study and will be included only if having a suitable contraception method.
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 |
|---|---|---|
| HIFUHigh Intensity focalized Ultrasounds | Device | Hifu |
Primary outcome
Proportion of patient with TSH normalization / increase
Time frame: 3 months
4 secondary outcomes
Number of patients with TSH normalization / increase
Time frame: 3 weeks, 6 months, 12 months
Changes of FT3 and FT4
Time frame: D3, D14, 6 weeks, M3, M6, M12
Change in the volume nodule
Time frame: 6 weeks, M3, M6 and M12
Number of adverse events
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Protocol's modifications requested by IRB weren't feasible to continue the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HIFU in people with Autonomous Hyperfunctioning Thyroid Nodules, run by Theraclion at 1 site in France.
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 14 inclusion and 11 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: stopped early, as of the sponsor's last update on 23 Jun 2014. 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 France. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Protocol's modifications requested by IRB weren't feasible to continue the study). Results are not available in the source record.
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?
Proportion of patient with TSH normalization / increase (time frame: 3 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 23 Jun 2014.