Thermal Ablation of Cervical Metastases From Thyroid Carcinoma

October 13, 2023 updated by: Instituto do Cancer do Estado de São Paulo

Ultrasound Guided Percutaneous Thermal Ablation of Cervical Metastases From Thyroid Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  1. To evaluate safety and efficacy of ultrasound-guided thermal ablation in the treatment of cervical lymph node metastases from differentiated thyroid carcinoma
  2. To evaluate the best response to thermal ablation defined as lymph node reduction or volume stability after ablation
  3. To evaluate the CEUS patterns of lymph nodes before and after ablation
  4. To evaluate the elastography patterns of lymph nodes before and after ablation
  5. To evaluate the tumor marker response after ablation
  6. To evaluate the contribution of thermal ablation to decrease additional therapeutic procedures
  7. 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.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 01246000
        • Recruiting
        • Instituto do Cancer do Estado de Sao Paulo
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ricardo MC Freitas, PhD
        • Sub-Investigator:
          • Ana O Hoff, PhD
        • Sub-Investigator:
          • Marco AV Kulcsar, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: Laser ablation
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;
Other Names:
  • LA
Active Comparator: 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.
Device: Cryoablation
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;
Other Names:
  • Cryo
Active Comparator: 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.
Device: Radiofrequency ablation
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;
Other Names:
  • RFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of technical feasibility
Time Frame: immediately after the procedure
defined as the ability to target the nodule and to perform ablation as preoperatively planned
immediately after the procedure
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of thermal ablation of thyroid carcinoma cervical lymph node metastases
Time Frame: up to 4 weeks post-ablation

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of technical success
Time Frame: immediately after the procedure
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
Evaluation of contrast-enhanced ultrasound pattern after thermal ablation therapy
Time Frame: 12 months
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
Evaluation of elastography pattern after thermal ablation therapy
Time Frame: 24 months
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
Time Frame: 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
Evaluation of tumor marker response
Time Frame: 24 months
Number of patients with tumor marker response: defined in negative thyroglobulin, calcitonin, or carcinoembryonic antigen (CEA) levels or anti-thyroglobulin antibodies
24 months
Evaluation of additional therapies
Time Frame: 24 months
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
Outcomes among thermal ablation therapies
Time Frame: 24 months
Number of patients with complications, side effects and tolerability in each ablation technique.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Investigators

  • Principal Investigator: Ricardo MC Freitas, PhD, Instituto do Cancer do Estado de Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2020

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 21, 2020

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1255/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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