BridgeMD
New treatment option for Thyroid Papillary Carcinoma
Official title Radiofrequency Ablation for Curative Treatment of Small Low-Risk Papillary Thyroid Cancer: Pilot Study
ClinicalTrials.gov ID: NCT07376837
What this study is testing
- What it's testing
- This pilot, single-arm clinical study evaluates the feasibility, safety, and effectiveness of radiofrequency ablation (RFA) as a curative treatment for small, low-risk papillary thyroid cancer (PTC). The study will enroll 30 adult patients (≥18 years) with biopsy-confirmed PTC measuring \<2 cm, who decline surgery or active surveillance, or who are transitioning from active surveillance to active treatment.
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed papillary thyroid carcinoma (PTC) by fine-needle aspiration (FNA -Bethesda V/VI ) or core needle biopsy.
- Single or multiple lesions, each 2.0 cm in maximum diameter.
- Intrathyroidal tumors (i.e., no extrathyroidal extension, no clinical/radiological evidence of nodal metastases, nor distant metastases).
- Lesions located at a safe distance (\>2 mm) from critical structures (e.g., trachea, esophagus, carotid artery) or accessible with hydrodissection.
- ≤T1b (i.e. \< 2cm maximal diameter), N0 or Nx, M0 (no clinical or radiological evidence of lymph node or distant metastasis).
You likely can't join if
- Evidence of lymph node involvement (clinically or radiologically suspicious or confirmed metastatic nodes) or distant metastasis (e.g., lung, bone).
- Tumors with extrathyroidal extension
- Tumors with extensive calcification
- Tumors located within 2 mm of critical structures where RFA would pose an unacceptably high risk and where hydrodissection is not feasible.
- Previous thyroid surgery or ablation (RFA, ethanol, laser, or microwave) at the index tumor site.
- Known diagnosis of anaplastic, poorly differentiated, or other aggressive thyroid cancer variants.
See the full eligibility criteria
- Histologically confirmed papillary thyroid carcinoma (PTC) by fine-needle aspiration (FNA -Bethesda V/VI ) or core needle biopsy.
- Single or multiple lesions, each 2.0 cm in maximum diameter.
- Intrathyroidal tumors (i.e., no extrathyroidal extension, no clinical/radiological evidence of nodal metastases, nor distant metastases).
- Lesions located at a safe distance (\>2 mm) from critical structures (e.g., trachea, esophagus, carotid artery) or accessible with hydrodissection.
- ≤T1b (i.e. \< 2cm maximal diameter), N0 or Nx, M0 (no clinical or radiological evidence of lymph node or distant metastasis).
- Patients unfit for surgery due to comorbidities or who refuse surgery.
- ≥18 years old
- Not pregnant at the time of RFA.
- Able to understand and voluntarily sign informed consent.
- Evidence of lymph node involvement (clinically or radiologically suspicious or confirmed metastatic nodes) or distant metastasis (e.g., lung, bone).
- Tumors with extrathyroidal extension
- Tumors with extensive calcification
- Tumors located within 2 mm of critical structures where RFA would pose an unacceptably high risk and where hydrodissection is not feasible.
- Previous thyroid surgery or ablation (RFA, ethanol, laser, or microwave) at the index tumor site.
- Known diagnosis of anaplastic, poorly differentiated, or other aggressive thyroid cancer variants.
- Pregnant or breastfeeding at the time of enrollment.
- Bleeding diathesis or use of anticoagulants that cannot be discontinued safely prior to RFA.
- Severe comorbid illness that limits life expectancy to less than 5 years.
- Inability to adhere to study follow-up schedule or procedures or lacking decision-making capacity.
- Implanted electrical devices such as pacemakers or neurostimulators
- Infection in the neck including skin infection or thyroiditis at time of planned ablation.
- Severe cervical anatomy distortion (prior neck surgery or radiation with distorted anatomy that prevents safe RFA
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.