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Thermal Ablation of Cervical Metastases From Thyroid Carcinoma

Primary Purpose

Thyroid Neoplasia, Well-Differentiated Thyroid Cancer, Medullary Thyroid Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Laser ablation
Cryoablation
Radiofrequency ablation
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Neoplasia focused on measuring differentiated thyroid cancer, medullary thyroid cancer, cervical lymph nodes, contrast-enhanced ultrasound, thermal ablation, laser ablation, radiofrequency ablation, cryoablation, elastography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto do Cancer do Estado de São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

laser ablation

cryoablation

Radiofrequency ablation

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Evaluation of technical feasibility
defined as the ability to target the nodule and to perform ablation as preoperatively planned
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of thermal ablation of thyroid carcinoma cervical lymph node metastases
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.

Secondary Outcome Measures

Evaluation of technical success
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
Evaluation of contrast-enhanced ultrasound pattern after thermal ablation therapy
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
Evaluation of elastography pattern after thermal ablation therapy
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.
Best response to the thermal ablation therapy
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.
Evaluation of tumor marker response
Number of patients with tumor marker response: defined in negative thyroglobulin, calcitonin, or carcinoembryonic antigen (CEA) levels or anti-thyroglobulin antibodies
Evaluation of additional therapies
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.
Outcomes among thermal ablation therapies
Number of patients with complications, side effects and tolerability in each ablation technique.

Full Information

First Posted
August 10, 2020
Last Updated
October 13, 2023
Sponsor
Instituto do Cancer do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04522570
Brief Title
Thermal Ablation of Cervical Metastases From Thyroid Carcinoma
Official Title
Ultrasound Guided Percutaneous Thermal Ablation of Cervical Metastases From Thyroid Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasia, Well-Differentiated Thyroid Cancer, Medullary Thyroid Cancer, Lymph Node Metastases
Keywords
differentiated thyroid cancer, medullary thyroid cancer, cervical lymph nodes, contrast-enhanced ultrasound, thermal ablation, laser ablation, radiofrequency ablation, cryoablation, elastography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laser ablation
Arm Type
Active Comparator
Arm 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.
Arm Title
cryoablation
Arm Type
Active Comparator
Arm 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.
Arm Title
Radiofrequency ablation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Laser ablation
Other Intervention Name(s)
LA
Intervention Description
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;
Intervention Type
Device
Intervention Name(s)
Cryoablation
Other Intervention Name(s)
Cryo
Intervention Description
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;
Intervention Type
Device
Intervention Name(s)
Radiofrequency ablation
Other Intervention Name(s)
RFA
Intervention Description
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;
Primary Outcome Measure Information:
Title
Evaluation of technical feasibility
Description
defined as the ability to target the nodule and to perform ablation as preoperatively planned
Time Frame
immediately after the procedure
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of thermal ablation of thyroid carcinoma cervical lymph node metastases
Description
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.
Time Frame
up to 4 weeks post-ablation
Secondary Outcome Measure Information:
Title
Evaluation of technical success
Description
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
Time Frame
immediately after the procedure
Title
Evaluation of contrast-enhanced ultrasound pattern after thermal ablation therapy
Description
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
Time Frame
12 months
Title
Evaluation of elastography pattern after thermal ablation therapy
Description
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.
Time Frame
24 months
Title
Best response to the thermal ablation therapy
Description
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.
Time Frame
24 months
Title
Evaluation of tumor marker response
Description
Number of patients with tumor marker response: defined in negative thyroglobulin, calcitonin, or carcinoembryonic antigen (CEA) levels or anti-thyroglobulin antibodies
Time Frame
24 months
Title
Evaluation of additional therapies
Description
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.
Time Frame
24 months
Title
Outcomes among thermal ablation therapies
Description
Number of patients with complications, side effects and tolerability in each ablation technique.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricardo MC Freitas, PhD
Phone
551138932945
Email
ricardo.freitas@hc.fm.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Ana O Hoff, PhD
Phone
551138932945
Email
ana.hoff@hc.fm.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo MC Freitas, PhD
Organizational Affiliation
Instituto do Cancer do Estado de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Cancer do Estado de São Paulo
City
São Paulo
ZIP/Postal Code
01246000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Talita R Vincunas
Phone
551138932945
Email
talita.vincunas@hc.fm.usp.br
First Name & Middle Initial & Last Name & Degree
Ricardo MC Freitas, PhD
Phone
551138932945
Email
ricardo.freitas@hc.fm.usp.br
First Name & Middle Initial & Last Name & Degree
Ricardo MC Freitas, PhD
First Name & Middle Initial & Last Name & Degree
Ana O Hoff, PhD
First Name & Middle Initial & Last Name & Degree
Marco AV Kulcsar, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcomes measures will be made available.
IPD Sharing Time Frame
Data will become available within 18 months of study completion and for 6 months.
IPD Sharing Access Criteria
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.
Citations:
PubMed Identifier
28807450
Citation
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.
Results Reference
background
PubMed Identifier
27845860
Citation
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.
Results Reference
background
PubMed Identifier
28342000
Citation
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.
Results Reference
background
PubMed Identifier
25450273
Citation
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.
Results Reference
background
PubMed Identifier
26911732
Citation
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.
Results Reference
background
PubMed Identifier
23150695
Citation
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.
Results Reference
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PubMed Identifier
17267329
Citation
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.
Results Reference
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PubMed Identifier
12679417
Citation
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.
Results Reference
background
PubMed Identifier
15496625
Citation
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.
Results Reference
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Thermal Ablation of Cervical Metastases From Thyroid Carcinoma

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