NCT04879355

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

1.5 years

First QC Date

March 7, 2021

Last Update Submit

June 29, 2022

Conditions

Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

  • Diagnostic rate

    The percentage of samples evaluated as "diagnostic" by the pathologist.

    1 year

Secondary Outcomes (3)

  • Complication rate

    Till 1 month after last inclusion. Corresponding to about 1 year

  • Pain assessment

    About 2 years

  • Diagnostic accuracy

    About 2 years

Study Arms (2)

Spinal needle

EXPERIMENTAL

Fine needle aspiration from thyroid nodules using af spinal needle.

Device: Spinal needle (25G)

Conventional fine needle

ACTIVE COMPARATOR

Fine needle aspiration from thyroid nodules using af conventional fine needle, which is traditionally used.

Device: Conventional fine needle (25G)

Interventions

Spinal needle (25G)DEVICE

Fine needle aspiration from thyroid nodules using a 25G spinal needle.

Spinal needle
Conventional fine needle (25G)DEVICE

Fine needle aspiration from thyroid nodules using a conventional 25G fine needle

Conventional fine needle

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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:
  • 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.

You may not qualify if:

  • Previous participation in the study.
  • Language or other barriers not allowing adequate information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University Hospital

Koege, 4600, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35959834DERIVED

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Tobias Andersen, MD

    Zealand University Hospital, Køge, Denmark.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Andersen, MD

CONTACT

28409266tobiasnicolaiandersen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The patients and the pathologists are blinded to the intervention, while the clinicians performing the FNAs are not.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 7, 2021

First Posted

May 10, 2021

Study Start

November 1, 2021

Primary Completion

May 1, 2023

Study Completion

November 1, 2023

Last Updated

July 5, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

Data collected in this trial can be shared upon request from other researchers after publication.

Shared Documents
STUDY PROTOCOL, ICF, CSR

Locations

DK(1)