Non-malignant Thyroid NoduleNCT02246504
Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
A study testing HIFU treatment in people with Non-malignant Thyroid Nodule, run by Theraclion at 1 site in Bulgaria.
Trial summary
The purpose of this study is to evaluate thyroid nodule's volume, structure and vascularisation changes following HIFU therapy assessed by ultrasonography Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-malignant Thyroid Nodule
- What is being tested?
- HIFU treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBulgaria
- Study dates
- 9 Oct 2012to 7 Mar 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient 18 years or older.
- Patient presenting with at least one thyroid nodule with no signs of malignancy:
- Non suspect clinically and at ultrasonography imaging
- Benign cytological diagnosis at FNAB from the last 6 months
- Normal serum calcitonin
- No history of neck irradiation
Show all 11Show fewer
- Normal TSH.
- Targeted nodule accessible and eligible to HIFU
- Absence of abnormal vocal cord mobility at laryngoscopy.
- Nodule diameter ≥ 10mm measured by ultrasound.
- Composition of the targeted nodule(s) : no more than 30% cystic
Who cannot join
- Head and/or neck disease that prevents hyperextension of neck.
- Known history of thyroid cancer or other neoplasias in the neck region.
- History of neck irradiation.
- Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment
- Posterior position of the nodule if the thickness of the nodule is <15mm
- Pregnant or lactating woman
- Any contraindication to IV neurolept analgesia.
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Clinic of thyroid and metabolite bone disease of the Acad. of Ivan Penchev UDHATE - 2, Zdrave street
Sofia, 14031
About this study
The purpose of this study is to evaluate thyroid nodule's volume, structure and vascularisation changes following HIFU therapy assessed by ultrasonography
Read the detailed description
HIFU treatment will be performed under conscious sedation under the supervision / responsibilities of an anesthetist.
A maximum of 2 HIFU sessions per nodule will be performed per patient. The decision to retreat the patient will be taken at 1 month post-HIFU or later.
Follow-up after HIFU treatment
D1 after HIFU session:
- Indirect laryngoscopy to check vocal cord mobility.
D7 after HIFU session
- Clinical examination (skin, local symptoms, oedema, voice….),
- Ultrasonography and Power Doppler,
M1 after HIFU session
- Clinical examination (skin, local symptoms, oedema, voice….),
- Ultrasonography and Power Doppler,
M3 after HIFU session
- Clinical examination (skin, local symptoms, oedema, voice….),
- Ultrasonography and Power Doppler Decision for an additional HIFU course to improve volume reduction.
In case of a second HIFU session D7b, M1b and M3b, M6b, M9b, M12b, M18b, M24b and M36b will be performed
M6 after last HIFU session
- Clinical examination (skin, local symptoms, oedema, voice….),
- Ultrasonography and Power Doppler
- TSH
- Free T4
- Antithyroid peroxidase antibodies
- Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery)
M9 after HIFU session
- Clinical examination (skin, local symptoms, oedema, voice….),
- Ultrasonography and Power Doppler
M12 after last HIFU session
- Clinical examination (skin, local symptoms, oedema, voice….),
- Ultrasonography and Power Doppler
- TSH
- Free T4
- Antithyroid peroxidase antibodies
- Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery)
M18, M24, M36 after HIFU session
- Clinical examination (skin, local symptoms, oedema, voice….),
- Ultrasonography and Power Doppler
- Conditions
- Non-malignant Thyroid Nodule
- Being tested
- HIFU treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFU treatmentDevice
| Study group | Role | What they receive |
|---|---|---|
| HIFU treatment | Experimental | use of HIFU treatment in patients with non-malignant thyroid nodules Receives: Device: HIFU treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in thyroid nodule's volume
Measured: Month 6
Secondary outcomes (2)
Change from baseline in thyroid nodule's structure and vascularisation
Measured: Month 6
Number of participants with adverse events
Measured: D1, D7, M1, M3 and M6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study start9 Oct 2012
- Primary completion7 Mar 2017
- Study completion7 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-malignant 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 (actual)
Sponsor and investigators
- Lead sponsor
- Theraclion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roussanka Kovatcheva, Prof., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246504
- Sponsor's protocol ID
- HIFU/BG/NT
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2014
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
- ClinicalTrials.gov ID
- NCT02246504
- Acronym / sponsor ID
- HIFU/BG/NT
- Conditions
- Non-malignant Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- TheraclionIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2012 (actual)
- Primary completion
- 7 Mar 2017 (actual)
- Study completion
- 7 Mar 2017 (actual)
- First posted
- 22 Sep 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 evaluate thyroid nodule's volume, structure and vascularisation changes following HIFU therapy assessed by ultrasonography
Detailed description
HIFU treatment will be performed under conscious sedation under the supervision / responsibilities of an anesthetist.
A maximum of 2 HIFU sessions per nodule will be performed per patient. The decision to retreat the patient will be taken at 1 month post-HIFU or later.
Follow-up after HIFU treatment
D1 after HIFU session:
- Indirect laryngoscopy to check vocal cord mobility.
D7 after HIFU session
- Clinical examination (skin, local symptoms, oedema, voice….),
- Ultrasonography and Power Doppler,
M1 after HIFU session
- Clinical examination (skin, local symptoms, oedema, voice….),
- Ultrasonography and Power Doppler,
M3 after HIFU session
- Clinical examination (skin, local symptoms, oedema, voice….),
- Ultrasonography and Power Doppler Decision for an additional HIFU course to improve volume reduction.
In case of a second HIFU session D7b, M1b and M3b, M6b, M9b, M12b, M18b, M24b and M36b will be performed
M6 after last HIFU session
- Clinical examination (skin, local symptoms, oedema, voice….),
- Ultrasonography and Power Doppler
- TSH
- Free T4
- Antithyroid peroxidase antibodies
- Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery)
M9 after HIFU session
- Clinical examination (skin, local symptoms, oedema, voice….),
- Ultrasonography and Power Doppler
M12 after last HIFU session
- Clinical examination (skin, local symptoms, oedema, voice….),
- Ultrasonography and Power Doppler
- TSH
- Free T4
- Antithyroid peroxidase antibodies
- Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery)
M18, M24, M36 after HIFU session
- Clinical examination (skin, local symptoms, oedema, voice….),
- Ultrasonography and Power Doppler
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFU treatment | Experimental | Device: HIFU treatmentuse of HIFU treatment in patients with non-malignant thyroid nodules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patient 18 years or older.
- Patient presenting with at least one thyroid nodule with no signs of malignancy:
- Normal TSH.
- Targeted nodule accessible and eligible to HIFU
- Absence of abnormal vocal cord mobility at laryngoscopy.
Key exclusion criteria (7 listed)
- Head and/or neck disease that prevents hyperextension of neck.
- Known history of thyroid cancer or other neoplasias in the neck region.
- History of neck irradiation.
- Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment
- Posterior position of the nodule if the thickness of the nodule is <15mm
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 |
|---|---|---|
| HIFU treatment | Device | HIFU treatment |
Primary outcome
Change from baseline in thyroid nodule's volume
Time frame: Month 6
2 secondary outcomes
Change from baseline in thyroid nodule's structure and vascularisation
Time frame: Month 6
Number of participants with adverse events
Time frame: D1, D7, M1, M3 and M6
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 17 Sep 2019.
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.
Roussanka Kovatcheva, Prof. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU treatment in people with Non-malignant Thyroid Nodule, run by Theraclion at 1 site in Bulgaria.
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 11 inclusion and 7 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 17 Sep 2019. 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 Bulgaria. 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?
Change from baseline in thyroid nodule's volume (time frame: Month 6). 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 17 Sep 2019.