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Thermal Ablation of Cervical Metastases From Thyroid Carcinoma

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 7 more changesShow less
    • Primary completion date changed from estimate of Nov 30, 2026 to Dec 22, 2025
    • Start date: Dec 14, 2020 to Dec 22, 2020
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 3 of 7 entries
    • Study description expanded, about 7 words
    • Site details revised
    • Publications: details revised at 9 of 9 entries
  2. Primary completion date: Nov 30, 2024 to Nov 30, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v7
  3. Primary completion date changed from estimate of Sep 30, 2024 to Nov 30, 2024
    • Study completion date: Sep 30, 2026 to Nov 30, 2026
    v6
  4. Enrollment target: 120 to 84v5
  5. Primary completion date: Dec 2022 to Sep 30, 2024
    • Study completion date: Dec 2023 to Sep 30, 2026
    v4
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  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Nov 2022 to Dec 2022
    • Study completion date: Nov 2023 to Dec 2023
    • Start date changed from estimate of Nov 2020 to Dec 14, 2020
    • Site details revised
  2. Primary completion date: Sep 2022 to Nov 2022v2 Show 5 more changesShow less
    • Study completion date: Sep 2023 to Nov 2023
    • Start date: Oct 2020 to Nov 2020
    • Secondary endpoints: details revised at 1 of 7 entries
    • Eligibility criteria shortened, about 1 word
    • Study description expanded, about 2 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04522570
Lead Sponsor Instituto do Cancer do Estado de São Paulo
Conditions
(from sponsor)		 Thyroid Neoplasia, Well-Differentiated Thyroid Cancer, Medullary Thyroid Cancer, Lymph Node Metastases
Related terms Carcinoma, Medullary, Lymphatic Metastasis, Thyroid Neoplasms
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov