Papillary Thyroid Microcarcinoma
Conditions
Keywords
thermal ablation, radiofrequency, papillary thyroid microcarcinoma, low-risk papillary thyroid carcinoma, mitt, thyroid intervention, Minimally Invasive Thyroid Treatment
Brief summary
Researchers in this study aim to prove the safety and efficacy of radiofrequency ablation in the treatment of a carefully selected low-risk papillary thyroid microcarcinoma patient group.
Interventions
PROCEDURERadiofrequency ablation alone
Ultrasound-guided percutaneous radiofrequency ablation of T1N0M0 papillary thyroid microcarcinomas
Sponsors
Premier G Med Cardio Kft
Hungarian Ministry of Innovation and Technology
Semmelweis University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with cytologically confirmed papillary thyroid carcinoma with the longest diameter of less than or equal to 10 mms in T1aN0M0 clinical stage without metastases and without cytological signs of aggressivity AND * Patients objecting to both surgery and active surveillance
Exclusion criteria
* History of or active disease: neck irradiation, stroke, CV disease, CNS vascular malformation, any malignant disease, immunocompromised state, recurrent laryngeal nerve paresis, organ failure * extrathyroidal extension of tumor (including capsular) * pregnancy * lesion less than 5 mm close to the danger zone * safety margin could not be obtained (min 2mm) * uncontrolled hyperthyroidism * uncontrolled hypothyroidism * primary hyperparathyroidism * calcitonin or serum calcium over the threshold on a repeat blood test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of patients without clinical evidence of a tumor on ultrasound and cytology on the treatment site | 24 months | We measure the number of patients without clinical evidence of a papillary thyroid microcarcinoma at the treatment site, evaluated with a (B-mode) ultrasound scan and a contrast-enhanced ultrasound scan of the whole tyroid and cytology reports from a fine needle aspiration from the site of the treatment at 24 months post-ablation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse effects | 24 months | Adverse effects measured during and after the procedure |
| Volume reduction ratio | 24 months | Volume reduction ratio: The volume reduction (initial volume minus final volume) compared to the original post-ablation volume, times 100. Volumes are measured on ultrasound. Length, width and depth is determined using the longest diameters on 3 perpendicular planes. Volume is reported in mL, calculated using the ellipsoid volume formula: (length x width x depth) x 0.524. |
Countries
Hungary
Contacts
PRINCIPAL_INVESTIGATORPál Á Deák, MD PhD associate professor
Semmelweis University
Outcome results
None listed