Clinical trial · Interventional
Thermal Ablation of Cervical Metastases From Thyroid Carcinoma
Ultrasound Guided Percutaneous Thermal Ablation of Cervical Metastases From Thyroid Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This study will evaluate the clinical response and safety of ultrasound guided percutaneous thermal ablation of lymph node metastases from thyroid carcinoma as an alternative to surgical treatment. The ablation of cervical lymph node metastases from differentiated thyroid carcinoma or medullary thyroid carcinoma will be directed to lesions larger than 0.8 cm, using ultrasound-guided radiofrequency ablation (RFA), laser ablation (LA) or cryoablation (Cryo) techniques, randomly assigned. Clinical and ultrasound monitoring will be carried out during 24 months, with examinations before the ablation procedure, immediately after including contrast-enhanced ultrasound (CEUS) when applicable, and B-mode, color Doppler and Shear-Wave elastography ultrasound follow up with 6, 12, and 24 months.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymph Node Metastases | — | UNRESOLVED | — |
| Medullary Thyroid Cancer | Thyroid Gland Medullary Carcinoma | ALIAS | 0.90 |
| Thyroid Neoplasia | — | UNRESOLVED | — |
| Well-Differentiated Thyroid Cancer | Differentiated Thyroid Gland Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoablation | Device | — | UNRESOLVED |
| Laser ablation | Device | — | UNRESOLVED |
| Radiofrequency ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- laser ablation
- description
- Percutaneous Laser Ablation for the treatment of metastatic cervical lymph nodes with \> 0.8 cm diameter with biopsy-proven diagnosis of differentiated thyroid carcinoma or medullary thyroid carcinoma.
- interventionNames
- Device: Laser ablation
- type
- ACTIVE_COMPARATOR
- label
- cryoablation
- description
- Percutaneous cryoablation for the treatment of metastatic cervical lymph nodes with \> 0.8 cm diameter with biopsy-proven diagnosis of differentiated thyroid carcinoma or medullary thyroid carcinoma.
- interventionNames
- Device: Cryoablation
- type
- ACTIVE_COMPARATOR
- label
- Radiofrequency ablation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Patients with fine needle aspiration biopsy (FNAb)-proven metastatic cervical lymph nodes at levels I, II, III, IV, V, VI or VII from differentiated thyroid carcinoma or medullary thyroid carcinoma who underwent total thyroidectomy and subsequent radioiodine therapy, in case of differentiated thyroid carcinoma. * Patients considered high surgical risk candidate or patients who are informed about the ablation therapy and prefers it instead surgery; * Patients with metastatic cervical lymph nodes over 0.8 cm diameter and under 4.0 cm diameter; no more than 6 simultaneous cervical nodal metastases; * Cervical recurrences in previously lateral neck dissection patients for differentiated thyroid carcinoma or medullary thyroid carcinoma over 0.8 cm diameter. Exclusion Criteria: * Age under 18 years * Uncorrectable coagulopathy; * Inconclusive or benign cytologic specimens; * Pregnancy or breast-feeding; * Anaplastic or poor-differentiated thyroid carcinoma; * Partial thyroidectomy * Cervical tumors not considered to surgery (invading vessels, nerves, larynx or trachea); * Serious medical illness, including any of the following: uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the baseline visit, uncontrolled congestive heart failure; * Participation in other studies that could affect the primary endpoint
References
Publications (9)
- BACKGROUNDHong YR, Luo ZY, Mo GQ, Wang P, Ye Q, Huang PT. Role of Contrast-Enhanced Ultrasound in the Pre-operative Diagnosis of Cervical Lymph Node Metastasis in Patients with Papillary Thyroid Carcinoma. Ultrasound Med Biol. 2017 Nov;43(11):2567-2575. doi: 10.1016/j.ultrasmedbio.2017.07.010. Epub 2017 Aug 12. PMID 28807450
- BACKGROUNDGuenette JP, Tuncali K, Himes N, Shyn PB, Lee TC. Percutaneous Image-Guided Cryoablation of Head and Neck Tumors for Local Control, Preservation of Functional Status, and Pain Relief. AJR Am J Roentgenol. 2017 Feb;208(2):453-458. doi: 10.2214/AJR.16.16446. Epub 2016 Nov 15. PMID 27845860
- BACKGROUNDGuang Y, Luo Y, Zhang Y, Zhang M, Li N, Zhang Y, Tang J. Efficacy and safety of percutaneous ultrasound guided radiofrequency ablation for treating cervical metastatic lymph nodes from papillary thyroid carcinoma. J Cancer Res Clin Oncol. 2017 Aug;143(8):1555-1562. doi: 10.1007/s00432-017-2386-6. Epub 2017 Mar 24. PMID 28342000
- BACKGROUNDWang L, Ge M, Xu D, Chen L, Qian C, Shi K, Liu J, Chen Y. Ultrasonography-guided percutaneous radiofrequency ablation for cervical lymph node metastasis from thyroid carcinoma. J Cancer Res Ther. 2014 Nov;10 Suppl:C144-9. doi: 10.4103/0973-1482.145844. PMID 25450273
- BACKGROUNDMauri G, Cova L, Ierace T, Baroli A, Di Mauro E, Pacella CM, Goldberg SN, Solbiati L. Treatment of Metastatic Lymph Nodes in the Neck from Papillary Thyroid Carcinoma with Percutaneous Laser Ablation. Cardiovasc Intervent Radiol. 2016 Jul;39(7):1023-30. doi: 10.1007/s00270-016-1313-6. Epub 2016 Feb 24. PMID 26911732
- BACKGROUNDPapini E, Bizzarri G, Bianchini A, Valle D, Misischi I, Guglielmi R, Salvatori M, Solbiati L, Crescenzi A, Pacella CM, Gharib H. Percutaneous ultrasound-guided laser ablation is effective for treating selected nodal metastases in papillary thyroid cancer. J Clin Endocrinol Metab. 2013 Jan;98(1):E92-7. doi: 10.1210/jc.2012-2991. Epub 2012 Nov 12.