Thyroid CancerFNA inadequacyNCT06984991
Factors Influencing Inadequacy in Rapid Onsite Evaluation of Ultrasound Guided Fine Needle Aspiration (FNA) Samples of Thyroid Nodules
A study testing fine needle aspiration in people with Thyroid Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
Thyroid nodules are a common clinical finding with a prevalence of around 50-67% in the general population using ultrasound examinations. Of these, malignancies account for 5-15% including the treatable papillary and follicular thyroid carcinomas and the rarer but more aggressive medullary and undifferentiated thyroid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- fine needle aspiration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients referred for FNA of thyroid nodules (TIRAD-3, 4 and 5 nodules).
Who cannot join
- History of thyroid ablation before FNA
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut, Asyut Governorate, 71515
ramy M MOhammed, consultant of radiology, 00201153070865, ramycolor@aun.edu.eg
ramy M Mohammed
About this study
Thyroid nodules are a common clinical finding with a prevalence of around 50-67% in the general population using ultrasound examinations. Of these, malignancies account for 5-15% including the treatable papillary and follicular thyroid carcinomas and the rarer but more aggressive medullary and undifferentiated thyroid cancers.
Fine Needle Aspiration (FNA) is a relatively simple, cost-effective recommended standard diagnostic procedure with high sensitivity and specificity for the preoperative evaluation of benign and malignant thyroid nodules.
Read more
Cytopathology reports of thyroid FNA are categorized using a universal grading system, which helps to standardize reporting of diagnostic thyroid cytology results. In the non-diagnostic/unsatisfactory category (Bethesda I), ranging from 1% to 20% of samples, pathologists are unable to make a clinical diagnosis based on these samples due to an inadequate number of cells or difficulty in identifying cells. The estimated risk of malignancy in this category is 1-4 %, which usually managed by repeating FNA with increase in patient discomfort, procedural complications and medical costs.
There are few other prospective studies investigated the effect of needle size, and sampling technique on sample adequacy.
Read the detailed description
Thyroid nodules are a common clinical finding with a prevalence of around 50-67% in the general population using ultrasound examinations. Of these, malignancies account for 5-15% including the treatable papillary and follicular thyroid carcinomas and the rarer but more aggressive medullary and undifferentiated thyroid cancers.
The American Thyroid Association has devised an algorithm "Thyroid Imaging Reporting and Data System (TI-RADS) for evaluation and management of thyroid nodules based on US pattern and size to recommend fine needle aspiration (FNA) cytology to minimize unnecessary FNAs/thyroid surgeries for nodules that are most likely benign and to avoid over-treating micropapillary thyroid carcinoma which is indolent. Fine Needle Aspiration (FNA) is a relatively simple, cost-effective recommended standard diagnostic procedure with high sensitivity and specificity for the preoperative evaluation of benign and malignant thyroid nodules.
Cytopathology reports of thyroid FNA are categorized using a universal grading system called The Bethesda System for Reporting Thyroid Cytopathology, which helps to standardize reporting of diagnostic thyroid cytology results [3]. In the non-diagnostic/unsatisfactory category (Bethesda I), ranging from 1% to 20% of samples, pathologists are unable to make a clinical diagnosis based on these samples due to an inadequate number of cells or difficulty in identifying cells. The estimated risk of malignancy in this category is 1-4 %, which usually managed by repeating FNA with increase in patient discomfort, procedural complications and medical costs.
Several retrospective and prospective studies investigated the factors associated with non-diagnostic samples rates, most of which focused on ultrasound guidance, the rapid on-site cytological evaluation and cystic components of the nodule. However, there are few other prospective studies investigated the other nodule characteristics, needle size, and sampling technique.
- Conditions
- Thyroid Cancer
- Being tested
- fine needle aspiration
- Keywords
- thyroid FNA
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fine needle aspirationDiagnostic test
Different needle sizes will be used in FNA sampling ; 5ml syringe with 21G needle, 3ml syringe with 23G needle or 22G Quincke tip spinal needle will be used for FNA. Needle insertion will be directed either trans-isthmic or lateral cervical approach. Aspirations will be conducted at different angles and within different nodule regions using a to-and-fro motion till getting blood stain in the needle hub to obtain representative samples. Maximum number of four passes will be performed within the nodule in a single session. Samples will be primarily obtained without suction via the capillary method. However, aspiration with suction will be applied if no aspirates could be obtained in the needle hub after routine capillary method. For mixed cystic solid lesions; FNA will be done from the solid component after aspiration of the cystic component
| Study group | Role | What they receive |
|---|---|---|
| thyroid FNA | Experimental | All FNAs will be performed by experienced radiologists (of 5-year experience in thyroid FNA procedures). Patients will be positioned comfortably, typically in a supine position with neck extension after putting a pillow under shoulders to fully expose the patient's neck to allow optimal access to the nodule. Ultrasound guidance using Logic E9 machine (GE Healthcare, Chicago, IL, USA) or Sonoscape X5 Portable Ultrasound machine with high-frequency linear array probes (3-12 MHz) will be used to visualize the nodule accurately and guide needle placement. 5ml syringe with 21G needle, 3ml syringe with 23G needle or 22G Quincke tip spinal needle will be used for FNA. Needle insertion will be directed either trans-isthmic or lateral cervical approach. Aspirations will be conducted at different angles and within different nodule regions using a to-and-fro motion till getting blood stain in the needle hub to obtain representative samples. Maximum number of four passes will be performed . Receives: Diagnostic Test: fine needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of sample adequacy
Aspirated material will be expelled onto glass slides, which will be immediately fixed and stained for cytological analysis. Rapid On-Site Evaluation (ROSE) will be utilized to assess the sample adequacy during the procedure using the diff-quik (air-dried) slides, allowing for additional passes if necessary. In this situation, ROSE is not used for bedside diagnosis.
An experienced pathologist reported the ical diagnosis/reporfinal cytologt only once the entire case (i.e. all of the slides) are reviewed according to the Bethesda criteria.:
(I) nondiagnostic (ND) (fewer than six groups of well-visualized follicular cells, each group containing less than 10 well-preserved epithelial cells); (II) benign lesion; (III) atypia of undetermined significance/follicular lesion of undetermined significance (AUS/FLUS); (IV) follicular neoplasm/suspicious for follicular neoplasm (FN/SFN); (V) suspicious for malignancy; and (VI) malignancy.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Jun 2025
- Primary completion1 Jul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramy Mohammed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984991
- Sponsor's protocol ID
- thyroid FNA
- Acronym
- FNA inadequacy
- Status last verified
- Jan 2026
- First submitted
- 3 May 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sander CJ. Anaesthetic risk to tervuerens. Vet Rec. 1979 Nov 24;105(21):496. doi: 10.1136/vr.105.21.496. No abstract available.
PubMed 538881Cibas ES, Ali SZ. The Bethesda System for Reporting Thyroid Cytopathology. Thyroid. 2009 Nov;19(11):1159-65. doi: 10.1089/thy.2009.0274.
PubMed 19888858Gharib H, Papini E, Garber JR, Duick DS, Harrell RM, Hegedus L, Paschke R, Valcavi R, Vitti P; AACE/ACE/AME Task Force on Thyroid Nodules. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS, AMERICAN COLLEGE OF ENDOCRINOLOGY, AND ASSOCIAZIONE MEDICI ENDOCRINOLOGI MEDICAL GUIDELINES FOR CLINICAL PRACTICE FOR THE DIAGNOSIS AND MANAGEMENT OF THYROID NODULES--2016 UPDATE. Endocr Pract. 2016 May;22(5):622-39. doi: 10.4158/EP161208.GL.
PubMed 27167915Moifo B, Moulion Tapouh JR, Dongmo Fomekong S, Djomou F, Manka'a Wankie E. Ultrasonographic prevalence and characteristics of non-palpable thyroid incidentalomas in a hospital-based population in a sub-Saharan country. BMC Med Imaging. 2017 Mar 4;17(1):21. doi: 10.1186/s12880-017-0194-8.
PubMed 28259145
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Inadequacy in Rapid Onsite Evaluation of Ultrasound Guided Fine Needle Aspiration (FNA) Samples of Thyroid Nodules
- ClinicalTrials.gov ID
- NCT06984991
- Acronym / sponsor ID
- FNA inadequacy / thyroid FNA
- Conditions
- Thyroid Cancer
- Keywords
- thyroid FNA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 22 May 2025 (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.
Thyroid nodules are a common clinical finding with a prevalence of around 50-67% in the general population using ultrasound examinations. Of these, malignancies account for 5-15% including the treatable papillary and follicular thyroid carcinomas and the rarer but more aggressive medullary and undifferentiated thyroid cancers.
Fine Needle Aspiration (FNA) is a relatively simple, cost-effective recommended standard diagnostic procedure with high sensitivity and specificity for the preoperative evaluation of benign and malignant thyroid nodules.
Cytopathology reports of thyroid FNA are categorized using a universal grading system, which helps to standardize reporting of diagnostic thyroid cytology results. In the non-diagnostic/unsatisfactory category (Bethesda I), ranging from 1% to 20% of samples, pathologists are unable to make a clinical diagnosis based on these samples due to an inadequate number of cells or difficulty in identifying cells. The estimated risk of malignancy in this category is 1-4 %, which usually managed by repeating FNA with increase in patient discomfort, procedural complications and medical costs.
There are few other prospective studies investigated the effect of needle size, and sampling technique on sample adequacy.
Detailed description
Thyroid nodules are a common clinical finding with a prevalence of around 50-67% in the general population using ultrasound examinations. Of these, malignancies account for 5-15% including the treatable papillary and follicular thyroid carcinomas and the rarer but more aggressive medullary and undifferentiated thyroid cancers.
The American Thyroid Association has devised an algorithm "Thyroid Imaging Reporting and Data System (TI-RADS) for evaluation and management of thyroid nodules based on US pattern and size to recommend fine needle aspiration (FNA) cytology to minimize unnecessary FNAs/thyroid surgeries for nodules that are most likely benign and to avoid over-treating micropapillary thyroid carcinoma which is indolent. Fine Needle Aspiration (FNA) is a relatively simple, cost-effective recommended standard diagnostic procedure with high sensitivity and specificity for the preoperative evaluation of benign and malignant thyroid nodules.
Cytopathology reports of thyroid FNA are categorized using a universal grading system called The Bethesda System for Reporting Thyroid Cytopathology, which helps to standardize reporting of diagnostic thyroid cytology results [3]. In the non-diagnostic/unsatisfactory category (Bethesda I), ranging from 1% to 20% of samples, pathologists are unable to make a clinical diagnosis based on these samples due to an inadequate number of cells or difficulty in identifying cells. The estimated risk of malignancy in this category is 1-4 %, which usually managed by repeating FNA with increase in patient discomfort, procedural complications and medical costs.
Several retrospective and prospective studies investigated the factors associated with non-diagnostic samples rates, most of which focused on ultrasound guidance, the rapid on-site cytological evaluation and cystic components of the nodule. However, there are few other prospective studies investigated the other nodule characteristics, needle size, and sampling technique.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thyroid FNA | Experimental | Diagnostic Test: fine needle aspirationAll FNAs will be performed by experienced radiologists (of 5-year experience in thyroid FNA procedures). Patients will be positioned comfortably, typically in a supine position with neck extension after putting a pillow under shoulders to fully expose the patient's neck to allow optimal access to the nodule. Ultrasound guidance using Logic E9 machine (GE Healthcare, Chicago, IL, USA) or Sonoscape X5 Portable Ultrasound machine with high-frequency linear array probes (3-12 MHz) will be used to visualize the nodule accurately and guide needle placement. 5ml syringe with 21G needle, 3ml syringe with 23G needle or 22G Quincke tip spinal needle will be used for FNA. Needle insertion will be directed either trans-isthmic or lateral cervical approach. Aspirations will be conducted at different angles and within different nodule regions using a to-and-fro motion till getting blood stain in the needle hub to obtain representative samples. Maximum number of four passes will be performed . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients referred for FNA of thyroid nodules (TIRAD-3, 4 and 5 nodules).
Key exclusion criteria (1 listed)
- History of thyroid ablation before FNA
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 |
|---|---|---|
| fine needle aspirationDifferent needle sizes will be used in FNA sampling ; 5ml syringe with 21G needle, 3ml syringe with 23G needle or 22G Quincke tip spinal needle will be used for FNA. Needle insertion will be directed either trans-isthmic or lateral cervical approach. Aspirations will be conducted at different angles and within different nodule regions using a to-and-fro motion till getting blood stain in the needle hub to obtain representative samples. Maximum number of four passes will be performed within the nodule in a single session. Samples will be primarily obtained without suction via the capillary method. However, aspiration with suction will be applied if no aspirates could be obtained in the needle hub after routine capillary method. For mixed cystic solid lesions; FNA will be done from the solid component after aspiration of the cystic component | Diagnostic test | thyroid FNA |
Primary outcome
rate of sample adequacy
Time frame: Day 1
Aspirated material will be expelled onto glass slides, which will be immediately fixed and stained for cytological analysis. Rapid On-Site Evaluation (ROSE) will be utilized to assess the sample adequacy during the procedure using the diff-quik (air-dried) slides, allowing for additional passes if necessary. In this situation, ROSE is not used for bedside diagnosis. An experienced pathologist reported the ical diagnosis/reporfinal cytologt only once the entire case (i.e. all of the slides) are reviewed according to the Bethesda criteria.: (I) nondiagnostic (ND) (fewer than six groups of well-visualized follicular cells, each group containing less than 10 well-preserved epithelial cells); (II) benign lesion; (III) atypia of undetermined significance/follicular lesion of undetermined significance (AUS/FLUS); (IV) follicular neoplasm/suspicious for follicular neoplasm (FN/SFN); (V) suspicious for malignancy; and (VI) malignancy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Background: PubMed 538881Sander CJ. Anaesthetic risk to tervuerens. Vet Rec. 1979 Nov 24;105(21):496. doi: 10.1136/vr.105.21.496. No abstract available.
- Background: PubMed 19888858Cibas ES, Ali SZ. The Bethesda System for Reporting Thyroid Cytopathology. Thyroid. 2009 Nov;19(11):1159-65. doi: 10.1089/thy.2009.0274.
- Background: PubMed 27167915Gharib H, Papini E, Garber JR, Duick DS, Harrell RM, Hegedus L, Paschke R, Valcavi R, Vitti P; AACE/ACE/AME Task Force on Thyroid Nodules. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS, AMERICAN COLLEGE OF ENDOCRINOLOGY, AND ASSOCIAZIONE MEDICI ENDOCRINOLOGI MEDICAL GUIDELINES FOR CLINICAL PRACTICE FOR THE DIAGNOSIS AND MANAGEMENT OF THYROID NODULES--2016 UPDATE. Endocr Pract. 2016 May;22(5):622-39. doi: 10.4158/EP161208.GL.
- Background: PubMed 28259145Moifo B, Moulion Tapouh JR, Dongmo Fomekong S, Djomou F, Manka'a Wankie E. Ultrasonographic prevalence and characteristics of non-palpable thyroid incidentalomas in a hospital-based population in a sub-Saharan country. BMC Med Imaging. 2017 Mar 4;17(1):21. doi: 10.1186/s12880-017-0194-8.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fine needle aspiration in people with Thyroid Cancer, run by Assiut University 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Feb 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ramy M Mohammed, MD of radiology (+201153070865, ramycolor@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of sample adequacy (time frame: Day 1). 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 NCT06984991, which also lists 4 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 3 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.