Active monitoring for small Bethesda IV thyroid nodules
Official title: Active Surveillance for Small Thyroid Nodules With Bethesda IV Cytology: A Prospective Cohort Study Protocol
Run by Copenhagen University Hospital, Rigshospitalet · NCT07370675 · Data updated 2026-11-12
This program will try active monitoring with scheduled ultrasounds and clinic visits instead of immediate surgery for adults with a single Bethesda IV thyroid nodule under 2 cm.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years and up |
| Sex | All |
| Enrollment | 165 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | January 16, 2026 |
| Main results expected | January 16, 2033 |
| Study ends | January 16, 2033 |
| Registry record updated | January 27, 2026 |
| Trial ID | NCT07370675 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 30 or older with a single Bethesda IV thyroid nodule under 2 cm in all dimensions and EU-TIRADS 3 or 4 on ultrasound who can provide informed consent are ideal candidates.
✕Probably not a fit
Patients with EU-TIRADS 5 or other high-risk ultrasound features, suspected lymph node or distant spread, extrathyroidal extension, high-risk nodule location, prior thyroid surgery, pregnancy, or elevated calcitonin are unlikely to benefit from surveillance and should pursue definitive treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective cohort enrolling adults aged 30 or older with a single Bethesda IV (follicular neoplasm) thyroid nodule smaller than 2 cm and EU-TIRADS 3–4 on ultrasound. Participants will follow an active surveillance schedule with ultrasound and clinical exams at 6, 12, 18, 24, 36, 48, and 60 months, together with patient education and symptom monitoring. Patients with high-risk ultrasound features, suspected nodal or distant spread, prior thyroid surgery, pregnancy, elevated calcitonin, or other exclusion criteria will be directed to standard care and are not enrolled. The protocol aims to document safety, feasibility, patient-reported experience, and clinicopathologic predictors of progression to inform whether surveillance can reduce overtreatment and preserve thyroid function.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary hemithyroidectomies, preserve natural thyroid function, lower surgical risks, and improve patient quality of life.
How similar studies have gone: Active surveillance has shown good outcomes for small, low-risk papillary thyroid cancers, but surveillance for Bethesda IV (follicular) nodules is less studied and remains relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * age of 30 years or older AND * a single nodule with a Follicular neoplasm or suspicious for a follicular neoplasm (category IV in the Bethesda system) AND * tumor size of less than 2 cm in all dimensions AND * EU-TIRADS 3 or 4 in Ultrasound imaging examination. Exclusion Criteria: * EU-TIRADS 5 in Ultrasound imaging examination. * suspicion of disseminated disease because of PET-positive lymph nodes; suspect lymph-nodes by US or by CT-scan; or signs of capsular invasion of the tumor, or irregular shape or margins, extrathyroidal growth OR * tumor placement at a high-risk location (in the thyroid capsule with extracapsular extension toward vessels, RLN, or the trachea) OR * previous thyroid surgery OR * concomitant hyperparathyroidism (ionized calcium \> 1.32 mmol/L and PTH \> 6 pmol/L) OR * if the patient is pregnant OR * If the patient is unable to give informed consent. OR * If calcitonin is elevated above normal level
Where it's running
-
Department of Otolaryngology, Head and Neck SurgeryRigshospitalet
Copenhagen, Denmark Recruiting
Study contacts
- Study coordinator: Nicoline Thorup, MD, PhD Fellow
- Email: nicoline.thorup@regionh.dk
- Phone: 0045 45356863
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.