search
Back to results

The Dose of Radioactive Iodine Needed to Ablate the Thyroid Remnant Left Behind After Thyroidectomy

Primary Purpose

Thyroid Neoplasms

Status
Unknown status
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
Radioactive iodine
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Neoplasms focused on measuring radioiodine, serum thyroglobulin, whole body radioiodine scanning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Total or near total thyroidectomy performed for papillary or follicular thyroid cancer R0-1 resection, no macroscopic cancer left behind at surgery Physically and emotionally able to undergo radioiodine treatment A written informed consent Exclusion criteria: Pregnancy Physical or psychiatric illness that may deteriorate during the isolation period required by radioiodine therapy

Sites / Locations

  • Helsinki University Central Hospital, Department of Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Radioactive iodine 1,1 GBq

Radioactive iodine 3,7 GBq

Arm Description

Low activity of radioiodine, 1,1 GBq

Routine activity of radioiodine, 3,7 GBq

Outcomes

Primary Outcome Measures

Cumulative number of radioactive iodine administrations

Secondary Outcome Measures

Adverse events
Absorbed radiation dose
Cancer recurrence

Full Information

First Posted
June 26, 2005
Last Updated
March 1, 2018
Sponsor
University of Helsinki
Collaborators
Helsinki University Central Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00115895
Brief Title
The Dose of Radioactive Iodine Needed to Ablate the Thyroid Remnant Left Behind After Thyroidectomy
Official Title
Effect of the Radioiodine Dose in Thyroid Ablation- A Randomized Comparison of 1110 MBq to 3700 MBq
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2000 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki
Collaborators
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The thyroid cells take up iodine, and radioactive iodine is commonly used to irradiate residual thyroid tissue and thyroid cancer following surgical removal of the thyroid gland (thyroidectomy). A whole body radioactive iodine scanning is usually carried out after thyroidectomy to assess the amount of thyroid tissue left behind at surgery (that might still contain cancer), and to evaluate the presence of iodine avid lesions elsewhere in the body (that might be cancer metastases). A large dose of radioactive iodine is often given, still the optimal iodine dose to ablate the thyroid remnant after surgery is not known. In this study, two radioactive iodine doses are compared in the ablation of the thyroid remnant, a smaller (1110 MBq) dose and a larger (3700 MBq) dose. The study participants are randomly allocated using a 1:1 ratio to receive either the smaller or the larger radioactive iodine dose. These treatments are compared for safety, adverse effects, and the need for subsequent repeat treatments. The individual absorbed radiation doses are measured. The study hypothesis is that fewer repeat radioiodine treatments might be needed after the larger dose, but the larger dose might be associated with a higher frequency of adverse events.
Detailed Description
The study participants are randomly allocated to receive either a 1110 MBq or a 3700 MBq dose of radioiodine (131I) approximately 5 weeks after thyroidectomy. Thyroxin substitution is initiated only after administration of radioactive iodine. Treatment efficacy is monitored using serum thyroglobulin measurements and whole body radioiodine scanning. The absorbed radiation dose at the thyroid remnant and the biological half-life of radioactive iodine are measured with SPECT, 131I iodine detector and a Geiger counter. Treatment related adverse events are collected using structured forms 4 to 5 days, 2 weeks and 3 months after administration of radioiodine. The need for a repeat treatment is assessed 4 to 6 months after the first administration of radioiodine. The criteria for a repeat radioiodine treatment are serum thyroglobulin > 1 ug/L and/or presence of abnormal radioiodine uptake in a whole body radioiodine scanning, which is carried out following a 4-week interruption of thyroxin supplementation or following administration of rhTSH. Number of patients: 160 Aims of the study: To find out weather the risk for second radioiodine treatment differs with two dose levels of radioiodine: 1110 MBq or 3700 MBq. To study possible differences in the adverse effects in the treatment groups. Also days at hospital are counted. To analyse the effect of absorbed radiation dose to the treatment results

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasms
Keywords
radioiodine, serum thyroglobulin, whole body radioiodine scanning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radioactive iodine 1,1 GBq
Arm Type
Experimental
Arm Description
Low activity of radioiodine, 1,1 GBq
Arm Title
Radioactive iodine 3,7 GBq
Arm Type
Other
Arm Description
Routine activity of radioiodine, 3,7 GBq
Intervention Type
Drug
Intervention Name(s)
Radioactive iodine
Other Intervention Name(s)
radioiodine
Intervention Description
Radioiodine is radionuclear treatment given in oral capsules in two activies 1,1 and 3,7 GBq
Primary Outcome Measure Information:
Title
Cumulative number of radioactive iodine administrations
Time Frame
15 yrs
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
15 yrs
Title
Absorbed radiation dose
Time Frame
15 yrs
Title
Cancer recurrence
Time Frame
15 yrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Total or near total thyroidectomy performed for papillary or follicular thyroid cancer R0-1 resection, no macroscopic cancer left behind at surgery Physically and emotionally able to undergo radioiodine treatment A written informed consent Exclusion criteria: Pregnancy Physical or psychiatric illness that may deteriorate during the isolation period required by radioiodine therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna O Mäenpää, M.D. Ph.D.
Organizational Affiliation
Deputy Chief Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital, Department of Oncology
City
Helsinki
ZIP/Postal Code
FIN-00029HUS
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
10348276
Citation
Roos DE, Smith JG. Randomized trials on radioactive iodine ablation of thyroid remnants for thyroid carcinoma--a critique. Int J Radiat Oncol Biol Phys. 1999 Jun 1;44(3):493-5.
Results Reference
background
PubMed Identifier
18382668
Citation
Maenpaa HO, Heikkonen J, Vaalavirta L, Tenhunen M, Joensuu H. Low vs. high radioiodine activity to ablate the thyroid after thyroidectomy for cancer: a randomized study. PLoS One. 2008 Apr 2;3(4):e1885. doi: 10.1371/journal.pone.0001885.
Results Reference
derived
Links:
URL
http://www.hus.fi
Description
Helsinki University Central Hospital

Learn more about this trial

The Dose of Radioactive Iodine Needed to Ablate the Thyroid Remnant Left Behind After Thyroidectomy

We'll reach out to this number within 24 hrs