NCT00115895

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2005

Completed
15.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

March 2, 2018

Status Verified

March 1, 2018

Enrollment Period

4.8 years

First QC Date

June 26, 2005

Last Update Submit

March 1, 2018

Conditions

Thyroid Neoplasms

Keywords

radioiodineserum thyroglobulinwhole body radioiodine scanning

Outcome Measures

Primary Outcomes (1)

  • Cumulative number of radioactive iodine administrations

    15 yrs

Secondary Outcomes (3)

  • Adverse events

    15 yrs

  • Absorbed radiation dose

    15 yrs

  • Cancer recurrence

    15 yrs

Study Arms (2)

Radioactive iodine 1,1 GBq

EXPERIMENTAL

Low activity of radioiodine, 1,1 GBq

Drug: Radioactive iodine

Radioactive iodine 3,7 GBq

OTHER

Routine activity of radioiodine, 3,7 GBq

Drug: Radioactive iodine

Interventions

Radioactive iodineDRUG

Radioiodine is radionuclear treatment given in oral capsules in two activies 1,1 and 3,7 GBq

Also known as: radioiodine
Radioactive iodine 1,1 GBqRadioactive iodine 3,7 GBq

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Physical or psychiatric illness that may deteriorate during the isolation period required by radioiodine therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital, Department of Oncology

Helsinki, FIN-00029HUS, Finland

Location

Related Publications (2)

  • 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.

    PMID: 10348276BACKGROUND

  • 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.

    PMID: 18382668DERIVED

Related Links

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Iodine-131

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Hanna O Mäenpää, M.D. Ph.D.

    Deputy Chief Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department

Study Record Dates

First Submitted

June 26, 2005

First Posted

June 27, 2005

Study Start

January 1, 2000

Primary Completion

October 1, 2004

Study Completion

September 1, 2020

Last Updated

March 2, 2018

Record last verified: 2018-03

Locations

FI(1)