Thyroid NeoplasmsPhase 3NCT00115895
The Dose of Radioactive Iodine Needed to Ablate the Thyroid Remnant Left Behind After Thyroidectomy
A Phase 3 study testing Radioactive iodine in people with Thyroid Neoplasms, run by University of Helsinki at 1 site in Finland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Neoplasms
- What is being tested?
- Radioactive iodine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2000to Sep 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Physical or psychiatric illness that may deteriorate during the isolation period required by radioiodine therapy
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Central Hospital, Department of Oncology
Helsinki, FIN-00029HUS
About this study
Official title: Effect of the Radioiodine Dose in Thyroid Ablation- A Randomized Comparison of 1110 MBq to 3700 MBq
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.
Read the 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
- Conditions
- Thyroid Neoplasms
- Being tested
- Radioactive iodine
- Keywords
- radioiodine, serum thyroglobulin, whole body radioiodine scanning
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioactive iodineDrug
Also called radioiodine
Radioiodine is radionuclear treatment given in oral capsules in two activies 1,1 and 3,7 GBq
| Study group | Role | What they receive |
|---|---|---|
| Radioactive iodine 1,1 GBq | Experimental | Low activity of radioiodine, 1,1 GBq Receives: Drug: Radioactive iodine |
| Radioactive iodine 3,7 GBq | Other | Routine activity of radioiodine, 3,7 GBq Receives: Drug: Radioactive iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative number of radioactive iodine administrations
Measured: 15 yrs
Secondary outcomes (3)
Adverse events
Measured: 15 yrs
Absorbed radiation dose
Measured: 15 yrs
Cancer recurrence
Measured: 15 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2005 (estimated)
- Study startJan 2000
- Primary completionOct 2004
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Principal investigator, Hanna Mäenpää, University of Helsinki
- Investigators
- Hanna O Mäenpää, M.D. Ph.D., Principal investigator, Deputy Chief Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115895
- Sponsor's protocol ID
- SYTJ001T/2000
- Status last verified
- Mar 2018
- First submitted
- 26 Jun 2005
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10348276Maenpaa 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.
PubMed 18382668
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Radioiodine Dose in Thyroid Ablation- A Randomized Comparison of 1110 MBq to 3700 MBq
- ClinicalTrials.gov ID
- NCT00115895
- Acronym / sponsor ID
- SYTJ001T/2000
- Conditions
- Thyroid Neoplasms
- Keywords
- radioiodine, serum thyroglobulin, whole body radioiodine scanning
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Study start
- Jan 2000
- Primary completion
- Oct 2004 (actual)
- Study completion
- Sep 2020 (estimated)
- First posted
- 27 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radioactive iodine 1,1 GBq | Experimental | Drug: Radioactive iodineLow activity of radioiodine, 1,1 GBq |
| Radioactive iodine 3,7 GBq | Other | Drug: Radioactive iodineRoutine activity of radioiodine, 3,7 GBq |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- Physical or psychiatric illness that may deteriorate during the isolation period required by radioiodine therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radioactive iodineAlso: radioiodineRadioiodine is radionuclear treatment given in oral capsules in two activies 1,1 and 3,7 GBq | Drug | Radioactive iodine 1,1 GBq, Radioactive iodine 3,7 GBq |
Primary outcome
Cumulative number of radioactive iodine administrations
Time frame: 15 yrs
3 secondary outcomes
Adverse events
Time frame: 15 yrs
Absorbed radiation dose
Time frame: 15 yrs
Cancer recurrence
Time frame: 15 yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
- Background: PubMed 10348276Roos 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.
- Derived from this study: PubMed 18382668Maenpaa 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.
- Helsinki University Central HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanna O Mäenpää, M.D. Ph.D. principal investigator
Deputy Chief Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radioactive iodine in people with Thyroid Neoplasms, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative number of radioactive iodine administrations (time frame: 15 yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00115895, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.