Active monitoring for small Bethesda IV thyroid nodules
Active Surveillance for Small Thyroid Nodules With Bethesda IV Cytology: A Prospective Cohort Study Protocol
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT07370675 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Copenhagen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.