RFA Treatment for Papillary Thyroid Microcarcinoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorColumbia University

About this trial

Thyroid surgery has always been the mainstay of treatment for thyroid cancer. Thyroid surgery carries a low risk of complications that include recurrent or superior laryngeal nerve injury leading to voice changes, hypoparathyroidism, hypothyroidism with need for thyroid hormone supplementation, and unsightly scarring. Although many patients with thyroid cancer find these risks acceptable, these risks are sometimes less acceptable to patients with benign disease. In an era when the medical field is treating thyroid diseases less aggressively, there is a pressing need to identify approaches to treat indolent malignant disease less invasively.

The purpose of this observational study is to evaluate the efficacy and safety of Radiofrequency Ablation (RFA) for treatment of Papillary Thyroid Microcarcinoma (PTMC) in patients that have already agreed to RFA procedure based on treating physician recommendation. This is a data collection study in which we ask participants to give us access to information generated before and after RFA treatment of their condition. The RFA procedure uses image guidance to place an electrode through the skin into the target tumor. In RFA, high-frequency electrical currents are passed through an electrode, creating a small region of heat to treat the lesion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (>/= 18 years)

Biopsy proven papillary thyroid microcarcinoma (>/= 1.5cm in greatest diameter, PTMC)

Either refuse surgery or are not good surgical candidates

Disqualifiers

Cardiac arrhythmia

Pregnancy

Trial population

Adult patients (\>/= 18 years) who have a biopsy proven papillary thyroid microcarcinoma (PTMC, \>/= 1.5cm in greatest diameter)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Radiofrequency Ablation

    Procedure/Surgery

    Ultrasound guided radiofrequency ablation

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Complete sonographic disappearance (CD)

Rate of complete sonographic disappearance of primary tumor s/p RFA

Time frame
12 months

Secondary outcomes

1

Complications

Procedural complications s/p RFA including but not limited to infection, bleeding, nerve injury, structural injury

Time frame
12 months

Other outcomes

Sponsors and contacts

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