Thyroid NeoplasmsPhase 3NCT00196729
Comparison of the Safety and Successful Ablation of Thyroid Remnant in Post-thyroidectomized Euthyroid Patients (i.e. Patients Administered Thyrogen) Versus Hypothyroid Patients (no Thyrogen) Following 131I Administration
A Phase 3 study testing Thyrogen + Radioiodine (131I) in people with Thyroid Neoplasms, run by Genzyme, a Sanofi Company.
Trial summary
This study was conducted in patients with differentiated thyroid cancer who had undergone near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation (use of radioiodine to remove any remaining thyroid tissue). Read more about this study
- Who is it for?
- Ages 20 to 68 years
- Conditions the study is for
- Thyroid Neoplasms
- What is being tested?
- Thyrogen + Radioiodine (131I)
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Dec 2001to Sep 2003
- 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 20 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were at least 18 years old (male or female).
- Patients with newly diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant, characterized as "T2, N0 or N1, and M0" or as "T1, N1, and M0".
- Patients with a total or near-total thyroidectomy within 2 weeks prior to enrollment.
Who cannot join
- see above
About this study
Official title: A Randomized, Controlled, Open-Label, Multi-National Pilot Study of Thyroid Remnant Ablation Comparing the Safety and Ablation Rate Following 131I Administration Using Thyrogen® Versus the Safety and Ablation Rate Following 131I Administration in the Hypothyroid State
This study was conducted in patients with differentiated thyroid cancer who had undergone near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation (use of radioiodine to remove any remaining thyroid tissue). One group of patients who took thyroid hormone medicine and were euthyroid [i.e. their thyroid stimulating hormone (TSH) levels are normal], and received injections of Thyrogen (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high), and were given oral radioiodine. All patients received the same amount of radioactive iodine (100 mCi or 3.7 GBq of 131I). Approximately 8 months later, whole body scans were performed on all patients to learn whether the thyroid remnants had been successfully ablated. The safety profile of Thyrogen when used for radioiodine remnant ablation also was assessed. The Quality of Life, the radioiodine uptake and retention into the thyroid bed, as well as radiation exposure to the remainder of the body also were assessed in both groups of patients.
Read the detailed description
Following a total/near-total thyroidectomy, eligible patients provided written informed consent within 14 days post-surgery. Patients were then randomized to 1 of 2 groups: the Euthyroid or the Hypothyroid group.
Once randomized, patients in the Euthyroid group received thyroid hormone suppression therapy (THST) for 4 weeks. At the end of the fourth week, the patient's TSH level was measured. If the TSH level was < 5 mU/L, Thyrogen (0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of Thyrogen, an ablative activity of 131I (100 mCi; 3.7 GBq) was administered. All patients then underwent post-treatment whole-body scanning (WBS) and remnant-neck imaging at 48 hours, at 72 to 96 hours, and at 96 to 168 hours (preferably 120 hours) following ablation. In addition, the study allowed for the option to perform scans at 24 hours and between 144 and 168 hours after ablation. Following the final post-treatment scan, patients in the Euthyroid group continued THST.
Patients randomized to the Hypothyroid Group did not receive THST after randomization. These individuals were monitored for at least 4 weeks or until their TSH was > 25 mU/L. Patients were given an ablative dose of 131I (100 mCi, 3.7 GBq). If the patient's TSH was < 25 mU/L at the end of the fourth week, the patient's TSH was measured again 1 week later. Patients then underwent post-treatment WBS and remnant-neck imaging at 48 hours, at 72 to 96 hours, and at 96 to 168 hours (preferably 120 hours) following ablation. In addition, the study allowed for the option to perform scans at 24 hours and between 144 and 168 hours post ablation. Following the final post-treatment scan, patients in the Hypothyroid group commenced THST.
Eight (± l) months later, patients in both the Euthyroid and Hypothyroid groups received Thyrogen (0.9 mg qd for 2 days) followed by an activity of 131I (4 mCi; 0.15 GBq), in preparation for 48-hour WBS and remnant-neck imaging.
Patients with a negative neck scan (i.e. no visible uptake or, if visible uptake, less than 0.1% uptake in the thyroid bed) 8 (+ 1) months following the 131I treatment were considered successfully ablated.
- Conditions
- Thyroid Neoplasms
- Being tested
- Thyrogen + Radioiodine (131I)
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyrogen + Radioiodine (131I)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Thyrogen in euthyroid patients undergoing radioiodine remnant ablation with 100 mCi (3.7 GBq) 131I results in a comparable ablation rate to patients undergoing radioiodine remnant ablation in the hypothyroid state with 100 mCi (3.7 GBq) 131I
Safety profile of Thyrogen when used for radioiodine remnant ablation
Secondary outcomes (2)
QoL in patients treated using Thyrogen
Compare the radioiodine uptake and retention into the thyroid bed in euthyroid patients using Thyrogen and patients treated in the hypothyroid state.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2001
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196729
- Sponsor's protocol ID
- THYR00800
- Status last verified
- Mar 2015
- First submitted
- 13 Sep 2005
- Last updated
- 18 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-Label, Multi-National Pilot Study of Thyroid Remnant Ablation Comparing the Safety and Ablation Rate Following 131I Administration Using Thyrogen® Versus the Safety and Ablation Rate Following 131I Administration in the Hypothyroid State
- ClinicalTrials.gov ID
- NCT00196729
- Acronym / sponsor ID
- THYR00800
- Conditions
- Thyroid Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Study completion
- Sep 2003
- First posted
- 20 Sep 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.
This study was conducted in patients with differentiated thyroid cancer who had undergone near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation (use of radioiodine to remove any remaining thyroid tissue). One group of patients who took thyroid hormone medicine and were euthyroid [i.e. their thyroid stimulating hormone (TSH) levels are normal], and received injections of Thyrogen (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high), and were given oral radioiodine. All patients received the same amount of radioactive iodine (100 mCi or 3.7 GBq of 131I). Approximately 8 months later, whole body scans were performed on all patients to learn whether the thyroid remnants had been successfully ablated. The safety profile of Thyrogen when used for radioiodine remnant ablation also was assessed. The Quality of Life, the radioiodine uptake and retention into the thyroid bed, as well as radiation exposure to the remainder of the body also were assessed in both groups of patients.
Detailed description
Following a total/near-total thyroidectomy, eligible patients provided written informed consent within 14 days post-surgery. Patients were then randomized to 1 of 2 groups: the Euthyroid or the Hypothyroid group.
Once randomized, patients in the Euthyroid group received thyroid hormone suppression therapy (THST) for 4 weeks. At the end of the fourth week, the patient's TSH level was measured. If the TSH level was < 5 mU/L, Thyrogen (0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of Thyrogen, an ablative activity of 131I (100 mCi; 3.7 GBq) was administered. All patients then underwent post-treatment whole-body scanning (WBS) and remnant-neck imaging at 48 hours, at 72 to 96 hours, and at 96 to 168 hours (preferably 120 hours) following ablation. In addition, the study allowed for the option to perform scans at 24 hours and between 144 and 168 hours after ablation. Following the final post-treatment scan, patients in the Euthyroid group continued THST.
Patients randomized to the Hypothyroid Group did not receive THST after randomization. These individuals were monitored for at least 4 weeks or until their TSH was > 25 mU/L. Patients were given an ablative dose of 131I (100 mCi, 3.7 GBq). If the patient's TSH was < 25 mU/L at the end of the fourth week, the patient's TSH was measured again 1 week later. Patients then underwent post-treatment WBS and remnant-neck imaging at 48 hours, at 72 to 96 hours, and at 96 to 168 hours (preferably 120 hours) following ablation. In addition, the study allowed for the option to perform scans at 24 hours and between 144 and 168 hours post ablation. Following the final post-treatment scan, patients in the Hypothyroid group commenced THST.
Eight (± l) months later, patients in both the Euthyroid and Hypothyroid groups received Thyrogen (0.9 mg qd for 2 days) followed by an activity of 131I (4 mCi; 0.15 GBq), in preparation for 48-hour WBS and remnant-neck imaging.
Patients with a negative neck scan (i.e. no visible uptake or, if visible uptake, less than 0.1% uptake in the thyroid bed) 8 (+ 1) months following the 131I treatment were considered successfully ablated.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who were at least 18 years old (male or female).
- Patients with newly diagnosed differentiated papillary or follicular thyroid carcinoma, including papillary-follicular variant, characterized as "T2, N0 or N1, and M0" or as "T1, N1, and M0".
- Patients with a total or near-total thyroidectomy within 2 weeks prior to enrollment.
Key exclusion criteria (1 listed)
- see above
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 |
|---|---|---|
| Thyrogen + Radioiodine (131I) | Drug | – |
Primary outcome
Use of Thyrogen in euthyroid patients undergoing radioiodine remnant ablation with 100 mCi (3.7 GBq) 131I results in a comparable ablation rate to patients undergoing radioiodine remnant ablation in the hypothyroid state with 100 mCi (3.7 GBq) 131I
Safety profile of Thyrogen when used for radioiodine remnant ablation
2 secondary outcomes
QoL in patients treated using Thyrogen
Compare the radioiodine uptake and retention into the thyroid bed in euthyroid patients using Thyrogen and patients treated in the hypothyroid state.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thyrogen + Radioiodine (131I) in people with Thyroid Neoplasms, run by Genzyme, a Sanofi Company.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Use of Thyrogen in euthyroid patients undergoing radioiodine remnant ablation with 100 mCi (3.7 GBq) 131I results in a comparable ablation rate to patients undergoing radioiodine remnant ablation in the hypothyroid state with 100 mCi (3.7 GBq) 131I. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2015.