Thyroid NodulePhase 1NCT03257930
Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules
A Phase 1 study testing ethanol injection in people with Thyroid Nodule, run by hassan harby mohamed at 1 site in Egypt.
Trial summary
Use of ethanol injection in treatment of cystic thyroid nodule Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- ethanol injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Aug 2017to 1 Jan 2019
- Phase
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adult male or female patient with cystic thyroid nodule
- Presence of pressure symptoms or cosmetic problems
- Benign lesions confirmed by histopathological examination by FNAC.
- Serum levels of thyroid hormone thyrotropin, within normal limits.
Who cannot join
- Nodules showing malignant features(ie, speculated margin, markedly hypo echoic, micro- or macro calcifications) at US
- solid thyroid nodule
- mixed thyroid nodule(cystic with solid component)
Trial locations and contacts
1 site in 1 country.
About this study
Use of ethanol injection in treatment of cystic thyroid nodule
Read the detailed description
Thyroid nodules are common discreet lesions in the parenchyma of thyroid gland which can either be palpated or made out during imaging like ultrasonography (USG).Clinically palpable thyroid nodules have a prevalence of 4-7% in the general population . However, the prevalence increases to 20-76% when USG is used for detection.
Goiter and the associated thyroid nodules result in anxiety, cosmetic disfigurement, and rarely compressive symptoms necessitating surgical removal, a procedure inherently associated with risks and complications Percutaneous sclerotherapy has been suggested to be an effective alternative, especially in patients with cystic nodules. Simple cystic (purely cystic) constitutes 6-28% of all thyroid nodules, are usually benign, filled with cellular debris or blood, and are a result of degeneration or hemorrhage into a hyperplastic nodule.
Among the various compounds (sodium tetradocyl sulfate, hydroxypolyethoxydodecan, tetracycline, and ethanol) tried for sclerosis of cystic thyroid nodules, outcomes are best and most studied with ethanol. However, data on outcomes of percutaneous aspiration and ethanol injection (PEI) in resolution of thyroid nodules is highly variable in different studies (success rate: 38-85%), which may be due to different populations studied and the heterogeneous nature of thyroid nodules evaluated.
- Conditions
- Thyroid Nodule
- Being tested
- ethanol injection
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethanol injectionDrug
inject ethanol in cystic thyroid nodule and follow up until complete recovery
| Study group | Role | What they receive |
|---|---|---|
| injection of ethanol | Experimental | use of ethanol injection in the treatment of cystic thyroid nodule Receives: Drug: ethanol injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of volume of the cyst about 96.9%
Reduction of volume of the cyst about 96.9%
Measured: Reduction of volume of the cyst about 96.9% within 6 month
Secondary outcomes (1)
symptomatic improvement
cosmetic improvement of the ugly appearance of the cyst from the neck
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start11 Aug 2017
- Primary completion11 Jul 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- hassan harby mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, hassan harby mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257930
- Sponsor's protocol ID
- Ethanol Injection
- Status last verified
- May 2020
- First submitted
- 17 Aug 2017
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vogel D, Durham AC, de Marcillac GD. Metastable aggregates in the polymerisation of tobacco-mosaic-virus protein. Eur J Biochem. 1977 Sep 15;79(1):161-71. doi: 10.1111/j.1432-1033.1977.tb11794.x. No abstract available.
PubMed 21087Monzani F, Lippi F, Goletti O, Del Guerra P, Caraccio N, Lippolis PV, Baschieri L, Pinchera A. Percutaneous aspiration and ethanol sclerotherapy for thyroid cysts. J Clin Endocrinol Metab. 1994 Mar;78(3):800-2. doi: 10.1210/jcem.78.3.8126160.
PubMed 8126160
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules
- ClinicalTrials.gov ID
- NCT03257930
- Acronym / sponsor ID
- Ethanol Injection
- Conditions
- Thyroid Nodule
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- hassan harby mohamedUniversity, hospital or other
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 11 Jul 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 22 Aug 2017 (actual)
- 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.
Use of ethanol injection in treatment of cystic thyroid nodule
Detailed description
Thyroid nodules are common discreet lesions in the parenchyma of thyroid gland which can either be palpated or made out during imaging like ultrasonography (USG).Clinically palpable thyroid nodules have a prevalence of 4-7% in the general population . However, the prevalence increases to 20-76% when USG is used for detection.
Goiter and the associated thyroid nodules result in anxiety, cosmetic disfigurement, and rarely compressive symptoms necessitating surgical removal, a procedure inherently associated with risks and complications Percutaneous sclerotherapy has been suggested to be an effective alternative, especially in patients with cystic nodules. Simple cystic (purely cystic) constitutes 6-28% of all thyroid nodules, are usually benign, filled with cellular debris or blood, and are a result of degeneration or hemorrhage into a hyperplastic nodule.
Among the various compounds (sodium tetradocyl sulfate, hydroxypolyethoxydodecan, tetracycline, and ethanol) tried for sclerosis of cystic thyroid nodules, outcomes are best and most studied with ethanol. However, data on outcomes of percutaneous aspiration and ethanol injection (PEI) in resolution of thyroid nodules is highly variable in different studies (success rate: 38-85%), which may be due to different populations studied and the heterogeneous nature of thyroid nodules evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| injection of ethanol | Experimental | Drug: ethanol injectionuse of ethanol injection in the treatment of cystic thyroid nodule |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adult male or female patient with cystic thyroid nodule
- Presence of pressure symptoms or cosmetic problems
- Benign lesions confirmed by histopathological examination by FNAC.
- Serum levels of thyroid hormone thyrotropin, within normal limits.
Key exclusion criteria (3 listed)
- Nodules showing malignant features(ie, speculated margin, markedly hypo echoic, micro- or macro calcifications) at US
- solid thyroid nodule
- mixed thyroid nodule(cystic with solid component)
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 |
|---|---|---|
| ethanol injectioninject ethanol in cystic thyroid nodule and follow up until complete recovery | Drug | injection of ethanol |
Primary outcome
Reduction of volume of the cyst about 96.9%
Time frame: Reduction of volume of the cyst about 96.9% within 6 month
Reduction of volume of the cyst about 96.9%
1 secondary outcome
symptomatic improvement
Time frame: 3 month
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 15 May 2020.
- Background: PubMed 21087Vogel D, Durham AC, de Marcillac GD. Metastable aggregates in the polymerisation of tobacco-mosaic-virus protein. Eur J Biochem. 1977 Sep 15;79(1):161-71. doi: 10.1111/j.1432-1033.1977.tb11794.x. No abstract available.
- Background: PubMed 8126160Monzani F, Lippi F, Goletti O, Del Guerra P, Caraccio N, Lippolis PV, Baschieri L, Pinchera A. Percutaneous aspiration and ethanol sclerotherapy for thyroid cysts. J Clin Endocrinol Metab. 1994 Mar;78(3):800-2. doi: 10.1210/jcem.78.3.8126160.
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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.
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 Phase 1 study testing ethanol injection in people with Thyroid Nodule, run by hassan harby mohamed at 1 site in Egypt.
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 4 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 15 May 2020. 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 Egypt. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Reduction of volume of the cyst about 96.9% (time frame: Reduction of volume of the cyst about 96.9% within 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03257930, which also lists 2 linked publications.
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 15 May 2020.