HILINER: Randomised Control Trial to determine the optimal dosing of radioactive iodine dosing in Intermediate/High risk papillary thyroid cancer

Randomised Control Trial to determine the optimal dosing of radioactive iodine dosing in Intermediate/High risk papillary thyroid cancer

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12625001167459

Enrollment

100

Registered

2025-10-24

Start date

2025-10-30

Completion date

2026-09-30

Last updated

2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to evaluate whether treatment with 1 GBq of radioactive iodine (RAI) is as effective as 4 GBq of RAI in patients with intermediate-risk or high-risk papillary thyroid cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with non-metastatic papillary thyroid cancer, and your cancer has been determined to be BRAF-positive (a specific genetic sub-type of this cancer). Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two treatment groups. Participants allocated to the first group will be asked to take a 1 GBq dose of radioactive iodine. Participants allocated to the second group will be asked to take 4 GBq dose of radioactive iodine. Participants in both groups will then be asked to complete blood tests and imaging of their thyroid every 3 months after their first dose for a 12 months. It is hoped this research will determine whether a 1 GBq dose of RAI is as effective or at least not any less effective than 4 GBq of RAI. If this study shows that a low dose of RAI is as effective as a high dose of RAI, this may be expanded to a larger study involving more patients with papillary thyroid cancer.

Interventions

- 1 GBq of radioactive iodine (RAI) for intermediate- or high-risk BRAF-positive papillary thyroid cancer, with no evidence of persistent or metastatic disease. RAI is administered orally as a single dose. - Treatment administered within 3 months post total or completion total thyroidectomy

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion criteria - Papillary thyroid cancer - BRAFV600E - High risk features (gross extrathyroidal extension, extra nodal involvement and greater than 3 LN, LN greater than 3cm ) or Intermediate risk features (greater or equal to 5 LN, vascular invasion, R1 disease) - Unstimulated Tg less than 1 ug/L - No known metastatic disease

Exclusion criteria

Exclusion criteria - FTC, Hurthle cell, anaplastic, poorly differentiated thyroid cancer - Unstimulated Tg greater than 1 ug/L - Tg Ab greater than 4.1IU/ml - R2 disease - Known metastatic disease - Pregnancy - Unable to consent or follow up

Outcome results