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Trial Title:
a. Reducing Radioiodine Treatment in Papillary Thyroid Cancer. RAILESS
NCT ID:
NCT06271044
Condition:
to Omit Radioiodine Treatment Safely in Patients With Low -Risk Papillary Thyroid Cancer With Seize of 11-20mm
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Diseases
Conditions: Keywords:
radioiodine treatment, low risk thyroid cancer, papillary thyroid cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients with low risk papillary thyroid cancer either received a radioiodine treatment
according to the normal Finnish treatment schedule or were schedulded for only follow-up
.
Primary purpose:
Other
Masking:
None (Open Label)
Masking description:
No masking.
Intervention:
Intervention type:
Other
Intervention name:
With radioiodine treatment
Description:
Postoperative radioiodine not given
Arm group label:
rairinn
Other name:
RAILESS
Intervention type:
Procedure
Intervention name:
With postoperative radioiodine treatment
Description:
Postoperative radioiodine given
Arm group label:
rairinn
Other name:
RAIRINN
Summary:
To study if its is safe to reduce the amount of postoperative treatments in those
patients, who have been operated on because of a low-risk intrathyroidal papillary
thyroid cancer with diameter of 11-20mm, and in whom postoperative thyroglobulin levels
are of low level.
Detailed description:
The purpose of the study : to enroll about 50 patients operated on because of a low-risk
intrathyroidal papillary thyroid cancer with diameter of 11-20mm, and in whom
postoperative thyroglobulin levels are of low level.
Methods: either to follow-up patients according to the study protocol without radioiodine
treatment or to give a radioiodine treatment with a dose of 1.1 GBq according to the
normal Finnish treatment protocol for papillary thyroid cancer to those patients who
themselves preferred to have a normal postoperative treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- low risk papillary intrathyroidal thyroid cancer with diameter of 11-20mm
- no lymphnode metastases
Exclusion Criteria:
- high risk papillary cancer
- mutlifocal papillary cancer
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Start date:
October 2014
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Helsinki University Central Hospital
Agency class:
Other
Source:
Helsinki University Central Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06271044
