Thyroid NoduleNCT04879355
Spinal Needles in Ultrasound-guided Fine Needle Aspirations From Thyroid Nodules
A study testing Spinal needle (25G) and Conventional fine needle (25G) in people with Thyroid Nodule, run by Preben Homøe at 1 site in Denmark.
Trial summary
This is a multicentre, two-arm, randomised and controlled trial. Adults with thyroid nodules suspected of malignancy are to be included consecutively. A total of 350 patients are randomly assigned 1:1 to have FNA with a spinal (25G) or a conventional (25G) needle. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Spinal needle (25G) and Conventional fine needle (25G)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2021to 1 Nov 2023
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age.
- Patients referred for evaluation of a cold nodule on thyroid scintigraphy and with EU-TIRADS score of 3 or higher.
- Score 3 and > 20 mm in size.
- Score 4 and >15 mm in size.
- Score 5 and >10 mm in size.
- Clinical suspicion of thyroid cancer:
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- PET-positive thyroid tumor.
- Thyroid tumor and palsy of the recurrent laryngeal nerve.
- Rapidly growing thyroid tumor.
- Hard and/or immobile thyroid tumor.
- Tumor in the thyroid with suspicious lymph nodes.
Who cannot join
- Previous participation in the study.
- Language or other barriers not allowing adequate information.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Zealand University Hospital
Koege, 4600
Tobias Andersen, MD, 28409266, tvennervald@gmail.com
About this study
Official title: The Use of Spinal Needles for Ultrasound-guided Fine Needle Aspiration From Thyroid Nodules - a Protocol for a Multicentre Randomised Controlled Trial
This is a multicentre, two-arm, randomised and controlled trial. Adults with thyroid nodules suspected of malignancy are to be included consecutively. A total of 350 patients are randomly assigned 1:1 to have FNA with a spinal (25G) or a conventional (25G) needle. The primary outcome is the rate of diagnostic cytological samples according to the Bethesda system. Secondary outcomes are diagnostic accuracy, patient's experienced pain and complication rates.
- Conditions
- Thyroid Nodule
- Being tested
- Spinal needle (25G), Conventional fine needle (25G)
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal needle (25G)Device
Fine needle aspiration from thyroid nodules using a 25G spinal needle.
Conventional fine needle (25G)Device
Fine needle aspiration from thyroid nodules using a conventional 25G fine needle
| Study group | Role | What they receive |
|---|---|---|
| Spinal needle | Experimental | Fine needle aspiration from thyroid nodules using af spinal needle. Receives: Device: Spinal needle (25G) |
| Conventional fine needle | Active comparator | Fine needle aspiration from thyroid nodules using af conventional fine needle, which is traditionally used. Receives: Device: Conventional fine needle (25G) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic rate
The percentage of samples evaluated as "diagnostic" by the pathologist.
Measured: 1 year
Secondary outcomes (3)
Complication rate
Complications, such as infections, bleedings or hematomas requiring treatment or admission, recurrent nerve injury and Horner's syndrome, will be recorded during the procedure. All patients are instructed to contact the department responsible for their management if they suspect complications. These will then be documented in the patient's medical record. At the end of the study period, the patient's medical records will be reviewed for admissions or contacts concerning complications.
Measured: Till 1 month after last inclusion. Corresponding to about 1 year
Pain assessment
Pain is assessed using the VAS (Visual Analog Scale) immediate after the procedure.
The score is ranging from 0 to 10 with higher numbers indicating a more painful procedure.
Measured: About 2 years
Diagnostic accuracy
Cytology from FNAB is compared with histology in the subgroup of patients who undergo surgery during the course of the study
Measured: About 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Nov 2021
- Primary completion1 May 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients are randomised at a 1:1-ratio to one of two parallel groups, and all patients are included in the analysis on an intention-to-treat basis.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Preben Homøe
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Preben Homøe, Zealand University Hospital
- Investigators
- Tobias Andersen, MD, Principal investigator, Zealand University Hospital, Køge, Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879355
- Sponsor's protocol ID
- SJ-878
- Status last verified
- Jun 2022
- First submitted
- 7 Mar 2021
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected in this trial can be shared upon request from other researchers after publication.
Publications
Andersen TV, Bennedbaek FN, Pedersen J, Rosenorn MR, Kiss K, Lelkaitis G, Andersen L, Hegedus L, Lomholt AF, Hahn CH, Hvilsom GB, Homoe P, Todsen T. Spinal versus conventional fine needle for ultrasound-guided thyroid nodule biopsy: a protocol for a randomised clinical trial. Dan Med J. 2022 Jul 21;69(8):A03220165.
PubMed 35959834
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Spinal Needles for Ultrasound-guided Fine Needle Aspiration From Thyroid Nodules - a Protocol for a Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04879355
- Acronym / sponsor ID
- SJ-878
- Conditions
- Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Preben HomøeUniversity, hospital or other
- Collaborators
- Herlev Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 10 May 2021 (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.
This is a multicentre, two-arm, randomised and controlled trial. Adults with thyroid nodules suspected of malignancy are to be included consecutively. A total of 350 patients are randomly assigned 1:1 to have FNA with a spinal (25G) or a conventional (25G) needle. The primary outcome is the rate of diagnostic cytological samples according to the Bethesda system. Secondary outcomes are diagnostic accuracy, patient's experienced pain and complication rates.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients are randomised at a 1:1-ratio to one of two parallel groups, and all patients are included in the analysis on an intention-to-treat basis.
| Arm | Type | Receives |
|---|---|---|
| Spinal needle | Experimental | Device: Spinal needle (25G)Fine needle aspiration from thyroid nodules using af spinal needle. |
| Conventional fine needle | Active comparator | Device: Conventional fine needle (25G)Fine needle aspiration from thyroid nodules using af conventional fine needle, which is traditionally used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥18 years of age.
- Patients referred for evaluation of a cold nodule on thyroid scintigraphy and with EU-TIRADS score of 3 or higher.
- Clinical suspicion of thyroid cancer:
Key exclusion criteria (2 listed)
- Previous participation in the study.
- Language or other barriers not allowing adequate information.
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 |
|---|---|---|
| Spinal needle (25G)Fine needle aspiration from thyroid nodules using a 25G spinal needle. | Device | Spinal needle |
| Conventional fine needle (25G)Fine needle aspiration from thyroid nodules using a conventional 25G fine needle | Device | Conventional fine needle |
Primary outcome
Diagnostic rate
Time frame: 1 year
The percentage of samples evaluated as "diagnostic" by the pathologist.
3 secondary outcomes
Complication rate
Time frame: Till 1 month after last inclusion. Corresponding to about 1 year
Pain assessment
Time frame: About 2 years
Diagnostic accuracy
Time frame: About 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Derived from this study: PubMed 35959834Andersen TV, Bennedbaek FN, Pedersen J, Rosenorn MR, Kiss K, Lelkaitis G, Andersen L, Hegedus L, Lomholt AF, Hahn CH, Hvilsom GB, Homoe P, Todsen T. Spinal versus conventional fine needle for ultrasound-guided thyroid nodule biopsy: a protocol for a randomised clinical trial. Dan Med J. 2022 Jul 21;69(8):A03220165.
- Individual participant dataSharing planned: Yes. Data collected in this trial can be shared upon request from other researchers after publication.
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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.
Tobias Andersen, MD principal investigator
Zealand University Hospital, Køge, Denmark.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal needle (25G) and Conventional fine needle (25G) in people with Thyroid Nodule, run by Preben Homøe at 1 site in Denmark.
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 2 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: status not confirmed, as of the sponsor's last update on 5 Jul 2022. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobias Andersen, MD (28409266 ext. 0045, tobiasnicolaiandersen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic rate (time frame: 1 year). 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 NCT04879355, which also lists 1 linked publication.
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 Jul 2022.