A pajzsmirigy karcinómából származó méhnyak-metasztázisok termikus ablációja
A pajzsmirigy karcinómából származó nyaki metasztázisok ultrahang által irányított perkután termikus ablációja
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
Thyroidectomy is the main treatment of well differentiated thyroid carcinoma. Residual or recurrent cervical metastases are common (9-20% of patients during long-term follow up). Thermal ablation of cervical metastatic lymph nodes from thyroid carcinoma has been proposed in research centers as an option for the treatment of patients who remain with metastatic disease in cervical lymph nodes, despite thyroidectomy with or without neck dissection associated with radioiodine treatment. Potential advantages from percutaneous thermal ablation are related to less complication rates, less morbidity, possibility of outpatient treatment modality, and less global treatment costs when compared to the surgical approach.
Aims of the study:
- To evaluate safety and efficacy of ultrasound-guided thermal ablation in the treatment of cervical lymph node metastases from differentiated thyroid carcinoma
- To evaluate the best response to thermal ablation defined as lymph node reduction or volume stability after ablation
- To evaluate the CEUS patterns of lymph nodes before and after ablation
- To evaluate the elastography patterns of lymph nodes before and after ablation
- To evaluate the tumor marker response after ablation
- To evaluate the contribution of thermal ablation to decrease additional therapeutic procedures
- To compare differences between LA, RFA and cryoablation in terms of complications, side effects and tolerability
Patients with cervical metastatic lymph nodes from differentiated thyroid carcinoma or medullary thyroid carcinoma who meet the eligibility criteria and who have been determined to be an appropriate candidate for local ablation therapy will be offered enrollment into the study. Patients agreeing to participate will become subjects of the study if they read and sign an informed consent form.
Treatment will be performed using three different ablation technologies (laser ablation, RFA or cryoablation) in a randomly assignment fashion.
Subjects will have up to six simultaneous treated lesions larger than 0.8 cm diameter with positive fine-needle aspiration biopsy. Ultrasound (and CEUS when applicable) will be performed over 24 months follow up in order to evaluate efficacy. Baseline and follow-up data will be collected for each subject via a web-based electronic data collection tool.
In case of recurrent disease treated by any ablative technique in patients who did not undergo previous neck dissection, a rescue neck dissection will be performed; in case of recurrent disease treated by any ablative technique in patients who underwent previous neck dissection, a new ablative technique approach will be considered.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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São Paulo
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São Paulo, São Paulo, Brazília, 01246000
- Instituto do Cancer do Estado de São Paulo
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Aktív összehasonlító: laser ablation
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. |
Single session with Diode laser ablation system; one or two applicators will be used for treatments; one to three illuminations; fixed output power of 3 watts (W); pullback technique; delivered energy: 1200-1800 Joules (J) varying according to tumor volume; treatment under local anesthesia +- conscious or moderate sedation;
Más nevek:
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Aktív összehasonlító: cryoablation
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. |
Single session with Argon-based cryoablation system; one 17 Gauge (G) V-probe applicator will be used for treatments; fixed gas delivery of 100%; treatment under local anesthesia +- conscious or moderate sedation;
Más nevek:
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Aktív összehasonlító: Radiofrequency ablation
Percutaneous radio frequency 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. |
Single session with radiofrequency generator; one 17 Gauge (G) V-tip applicator with a 1 to 4cm active tip; moving-shot technique or multiple overlapping shot technique with 60 Watts (W) output power; treatment under local anesthesia +- conscious or moderate sedation;
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Evaluation of technical feasibility
Időkeret: immediately after the procedure
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defined as the ability to target the nodule and to perform ablation as preoperatively planned |
immediately after the procedure
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Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of thermal ablation of thyroid carcinoma cervical lymph node metastases
Időkeret: up to 4 weeks post-ablation
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Evaluation of minor and major complication rates, immediately after ablation; and one- and four-weeks post-ablation by telephone call. Minor and major complication rates [Designed as a safety issue: Yes]. The safety endpoint for this study is to assess the incidence and severity of procedure or device-related adverse events, as reported by the Common Terminology Criteria of Adverse Events - CTCAE V5. 2017 Version. |
up to 4 weeks post-ablation
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Evaluation of technical success
Időkeret: immediately after the procedure
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Defined as the complete absence of color Doppler or, if applicable when tumors over 1.0 cm diameter, enhancement by contrast-enhanced ultrasound in the treated nodule |
immediately after the procedure
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Evaluation of contrast-enhanced ultrasound pattern after thermal ablation therapy
Időkeret: 12 months
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Absence of enhancement is expected in treated cervical lymph nodes after local ablative therapy in comparison to pre-treatment enhancement pattern. Partial enhancement may indicate residual tumoral tissue requiring new ablation session |
12 months
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Evaluation of elastography pattern after thermal ablation therapy
Időkeret: 24 months
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Quantitative measurements of nodule stiffness designated by the most representative region of interest within the nodule estimating of Young's modulus in kilopascal (KPa) and shear wave velocity in centimetres per second (cm/s) of treated cervical lymph nodes after local ablative therapy in comparison to pre-treatment pattern. |
24 months
|
|
Best response to the thermal ablation therapy
Időkeret: 24 months
|
The best response is defined as a subject having local disease control related to lymph node volume reduction or volume stability in percentage will be assessed by ultrasound measurement in comparison to pre-treatment volume. |
24 months
|
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Evaluation of tumor marker response
Időkeret: 24 months
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Number of patients with tumor marker response: defined in negative thyroglobulin, calcitonin, or carcinoembryonic antigen (CEA) levels or anti-thyroglobulin antibodies |
24 months
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Evaluation of additional therapies
Időkeret: 24 months
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Number of patients with additional therapies: Additional therapies for persistent/recurrent local disease associated with the index tumor (s) under study or new cervical lymph node metastases. |
24 months
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Outcomes among thermal ablation therapies
Időkeret: 24 months
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Number of patients with complications, side effects and tolerability in each ablation technique. |
24 months
|
Együttműködők és nyomozók
Nyomozók
- Kutatásvezető: Ricardo MC Freitas, PhD, Instituto do Cancer do Estado de São Paulo
Publikációk és hasznos linkek
Általános kiadványok
- Hong 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.
- Guenette 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.
- Guang 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.
- Wang 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.
- Mauri 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.
- Papini 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.
- Baudin E, Schlumberger M. New therapeutic approaches for metastatic thyroid carcinoma. Lancet Oncol. 2007 Feb;8(2):148-56. doi: 10.1016/S1470-2045(07)70034-7.
- Monaco F. Classification of thyroid diseases: suggestions for a revision. J Clin Endocrinol Metab. 2003 Apr;88(4):1428-32. doi: 10.1210/jc.2002-021260. No abstract available.
- Hegedus L. Clinical practice. The thyroid nodule. N Engl J Med. 2004 Oct 21;351(17):1764-71. doi: 10.1056/NEJMcp031436. No abstract available.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Endokrin rendszer betegségei
- Patológiás folyamatok
- Neoplazmák webhelyenként
- Neoplazmák
- Neoplazmák szövettani típus szerint
- Endokrin mirigy neoplazmák
- A fej és a nyak daganatai
- Neoplazmák, mirigyes és epiteliális
- Adenokarcinóma
- Neoplasztikus folyamatok
- Karcinóma
- Neuroektodermális daganatok
- Neoplazmák, csírasejt és embrionális
- Neoplazmák, idegszövet
- Neuroendokrin daganatok
- Pajzsmirigy betegségek
- Neoplazmák, duktális, lebenyes és medullaris
- Karcinóma, neuroendokrin
- Neoplazma metasztázis
- Kóros állapotok, jelek és tünetek
- Karcinóma, medulláris
- Pajzsmirigy neoplazmák
- Nyirokmetasztázis
- Nyomozási technikák
- Terápiás kezelés
- Diagnosztikai technikák és eljárások
- Diagnózis
- Műtéti eljárások, operatív
- Diagnosztikai képalkotás
- Ablációs technikák
- Rádióterápia
- Mikroszkópia
- Mikroszkópia, elektron
- Krioszebéria
- Rádiófrekvenciás abláció
- Lézerterápia
- Cryoelectron Microscopy
Egyéb vizsgálati azonosító számok
- 1255/18
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
De-identified individual participant data for all primary and secondary outcomes measures will be made available.
IPD megosztási időkeret
Data will become available within 18 months of study completion and for 6 months.
IPD-megosztási hozzáférési feltételek
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ICF
- ANALYTIC_CODE
- CSR
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