Primary Parathyroid AdenomasNCT01060982
Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU) Treatment Procedure
A study testing Ultrasonic ablation device in people with Primary Parathyroid Adenomas, run by Theraclion at 2 sites in France.
Trial summary
This study is a multicentre, open, uncontrolled trial for the observation of histological changes in parathyroid adenomas following high intensity focused ultrasound (HIFU). This study will be conducted in France in 10 patients with primary hyperparathyroidism scheduled for a parathyroidectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Parathyroid Adenomas
- What is being tested?
- Ultrasonic ablation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2010to Jan 2013
- 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.
- Patients with diagnosed primary hyperparathyroidism (clinical symptoms and/or biochemical disturbances) scheduled for parathyroidectomy.
- One diseased parathyroid gland, visualized by ultrasonography.
- The diseased targeted parathyroid gland accessible for HIFU treatment (anonymised ultrasonographic images to be sent to the sponsor's technical team for validation).
- Normal pretreatment nasofibroscopy.
- Voluntary signed informed consent.
Who cannot join
- Inaccessibility or high risk of targeting neighbouring structures, as evidenced by:
- Targeted area located less than 2 mm laterally from the oesophagus or the carotid artery
- Targeted area located less than 3 mm laterally from the trachea,
- Significant hyperechoic area with a posterior shadow located less than 10 mm behind the targeted area (behind to be understood as posterior to the targeted area in the direction of the HIFU beam)
- Investigator appreciation of any abnormal blood test that could contraindicate treatment with HIFU (bleeding abnormalities)
- Known spondylitis of the neck vertebrae
Show all 13Show fewer
- Head and/or neck disease that prevents hyperextension of neck.
- Known history of parathyroid or other neoplasias in the neck region.
- History of neck irradiation
- Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit
- Pregnant or lactating woman.
- Female patient of childbearing age if not having a suitable contraception method.
- Patients who have received any investigational drug or device within the last 15 days and/or patients who are currently participating in another clinical trial.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Privé des Peupliers
Paris, 75013
Cochin Hospital
Paris, 75014
About this study
Official title: Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU)Treatment Procedure: A Monocentre, Open, Uncontrolled Study
This study is a multicentre, open, uncontrolled trial for the observation of histological changes in parathyroid adenomas following high intensity focused ultrasound (HIFU).
This study will be conducted in France in 10 patients with primary hyperparathyroidism scheduled for a parathyroidectomy. The patient will receive an HIFU treatment in the center of the adenoma before the surgery.
- Conditions
- Primary Parathyroid Adenomas
- Being tested
- Ultrasonic ablation device
- Keywords
- Primary hyperparathyroidism, High Intensity Focused Ultrasound, Parathyroid tumor, Parathyroid hormone, Calcium
- Medical subject headings
- Hyperparathyroidism, Primary, Parathyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic ablation deviceDevice
Also called TH-One
One High Intensity focused ultrasound session before surgery. Use of appropriate energy for each patient
| Study group | Role | What they receive |
|---|---|---|
| HIFU treatment | Experimental | Not described Receives: Device: Ultrasonic ablation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histology of excised gland.
Measured: After surgery performed the same day as High intensity focused ultrasound treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Parathyroid AdenomasStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theraclion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe BONNICHON, MD, Principal investigator, Cochin Hospital, Paris, Fance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060982
- Sponsor's protocol ID
- HIFU/F/12.02
- Status last verified
- May 2014
- First submitted
- 1 Feb 2010
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Histological Changes in Parathyroid Adenomas Following High Intensity Focused Ultrasound (HIFU)Treatment Procedure: A Monocentre, Open, Uncontrolled Study
- ClinicalTrials.gov ID
- NCT01060982
- Acronym / sponsor ID
- HIFU/F/12.02
- Conditions
- Primary Parathyroid Adenomas
- Keywords
- Primary hyperparathyroidism, High Intensity Focused Ultrasound, Parathyroid tumor, Parathyroid hormone, Calcium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- TheraclionIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 2 Feb 2010 (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 study is a multicentre, open, uncontrolled trial for the observation of histological changes in parathyroid adenomas following high intensity focused ultrasound (HIFU).
This study will be conducted in France in 10 patients with primary hyperparathyroidism scheduled for a parathyroidectomy. The patient will receive an HIFU treatment in the center of the adenoma before the surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFU treatment | Experimental | Device: Ultrasonic ablation device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patient 18 years or older.
- Patients with diagnosed primary hyperparathyroidism (clinical symptoms and/or biochemical disturbances) scheduled for parathyroidectomy.
- One diseased parathyroid gland, visualized by ultrasonography.
- The diseased targeted parathyroid gland accessible for HIFU treatment (anonymised ultrasonographic images to be sent to the sponsor's technical team for validation).
- Normal pretreatment nasofibroscopy.
Key exclusion criteria (13 listed)
- Inaccessibility or high risk of targeting neighbouring structures, as evidenced by:
- Investigator appreciation of any abnormal blood test that could contraindicate treatment with HIFU (bleeding abnormalities)
- Known spondylitis of the neck vertebrae
- Head and/or neck disease that prevents hyperextension of neck.
- Known history of parathyroid or other neoplasias in the neck region.
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 |
|---|---|---|
| Ultrasonic ablation deviceAlso: TH-OneOne High Intensity focused ultrasound session before surgery. Use of appropriate energy for each patient | Device | HIFU treatment |
Primary outcome
Histology of excised gland.
Time frame: After surgery performed the same day as High intensity focused ultrasound treatment
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 6 May 2014.
Related trials for Primary Parathyroid Adenomas
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Parathyroid Adenoma Detection With Rubidium-82 Imaging
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Agnostic Therapy in Rare Solid Tumors
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RecruitingObservational study
Molecular and Immunohistochemical Profiling of Tumors in Patients With Parathyroid Tumors
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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.
Philippe BONNICHON, MD principal investigator
Cochin Hospital, Paris, Fance
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic ablation device in people with Primary Parathyroid Adenomas, run by Theraclion at 2 sites 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 6 inclusion and 13 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 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Histology of excised gland. (time frame: After surgery performed the same day as High intensity focused ultrasound treatment). 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 6 May 2014.