Nodular GoiterPhase 2NCT00275171
rhTSH, Radioiodine Uptake and Goiter Reduction Following 131I Therapy in Patients With Benign Nontoxic Nodular Goiter
A Phase 2 study testing Recombinant human thyrotropin (Thyrogen) and recombinant human TSH in people with Nodular Goiter, run by Steen Bonnema at 1 site in Denmark.
Trial summary
The study aims at clarifying (in a randomized, double-blinded design): 1. Whether stimulation with 0.1 mg rhTSH 24, 48 or 72 hours before induction of a 131I-tracer dosis increases the 131I uptake in patients with atoxic multinodular goitre and to study which time interval is the most optimal (Part I) 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nodular Goiter
- What is being tested?
- Recombinant human thyrotropin (Thyrogen) and recombinant human TSH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2006to Sep 2009
- Phase
- Phase 2
- 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
- Age over 18 years
- Apart from benign non-toxic goiter no other serious illness
- Signed proof of participation
Who cannot join
- Treatment with Levothyroxine
- Former 131I-therapy
- A thyroid volume above 100 ml or a retro-clavicular component
- Unsafe contraception
- Pregnancy or breastfeeding
- Participation in another clinical trial
Show all 11Show fewer
- Previous allergic reaction toward rhTSH
- Suspicion of malignancy in the thyroid gland either by clinical examination, laboratory findings (a raised serum calcitonin or ionized calcium)or by fine-needle aspiration biopsy
- Physically or mental condition making it impossible to participate
- Acute ischemic heart attach within the last 3 months
- Alcohol and/or drug addicts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of 0.1 mg Recombinant Human Thyrotropin (rhTSH) on Thyroid Radioiodine-uptake and the Degree of Goiter Reduction Following 131I-therapy, in Patients With Benign Non-toxic Nodular Goiter. A Randomized, Double-blind, Placebo-controlled Trial.
The study aims at clarifying (in a randomized, double-blinded design):
- Whether stimulation with 0.1 mg rhTSH 24, 48 or 72 hours before induction of a 131I-tracer dosis increases the 131I uptake in patients with atoxic multinodular goitre and to study which time interval is the most optimal (Part I)
- Whether patients suffering from atoxic multinodular goitre obtains a corresponding goitre reduction compared with a control group when stimulating with 0.1 mg rh TSH 24, 48 or 72 hours before 131I therapy and when reducing the thyroid radiation dose to 50 Gy (Part II)
The two studies will be carried out successively on the same patient population. The 131I uptake will be carried out first followed by the I therapy itself. The patients are compared with a placebo-treated control group going through the same course of treatment, but the 131I dosis will be 100 Gy (standard treatment). After the 131I therapy, all patients are followed during one year with a regular ultrasound scan of the thyroid gland and control of the metabolic status. The patient satisfaction is monitored by the use of a visual-analogue-scale.
- Conditions
- Nodular Goiter
- Being tested
- Recombinant human thyrotropin (Thyrogen), recombinant human TSH, isotonic saline = placebo
- Keywords
- Nontoxic nodular goiter, 131I therapy, thyroid radioiodine uptake, optimal time-interval, reduced 131I activity, goiter reduction
- Medical subject headings
- Goiter, Nodular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human thyrotropin (Thyrogen)Drug
0.1 mg rhTSH administered intramuscularly
recombinant human TSHDrug
0.1 mg rhTSH administered intramuscularly
isotonic saline = placeboOther
0.1 mg isotonic saline injected intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| rhTSH | Active comparator | proceeded by 0.1 mg rhTSH Receives: Drug: Recombinant human thyrotropin (Thyrogen); Drug: recombinant human TSH |
| Placebo | Placebo comparator | 1 ml isotonic saline Receives: Other: isotonic saline = placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
An intra-individual comparison of the thyroid 131I-uptake before and after stimulation with rhTSH /placebo
Measured: 24 and 96 hours after tracer administration
An inter-individual comparison of the thyroid 131I uptake between those who receive placebo and those who receive rhTSH
Measured: 24 and 96 hours after tracer administration
An estimation of which time-interval, injecting rhTSH, that is more favourable before 131I therapy (24 hours, 48 hours or 72 hours)
Measured: 24 and 96 hours after tracer administration
A comparison of the degree of goiter reduction when patients are prestimulated with rhTSH and receive a thyroid 131I dose of 50 Gy or when receiving conventional 131I, receiving a thyroid dose of 100 Gy
Measured: 3, 6, 9 and 12 months after 131I therapy
Secondary outcomes (4)
A registration of adverse effects following rhTSH/placebo
Measured: All adverse effects occuring within one year follow-up
Patient satisfaction (Visual Analogue Scale) before, 3 months post 131I therapy, and at the end of follow-up (1 year).
Measured: baseline, 3 and 12 months after 131I therapy
Development of TPOab or TSHRab
Measured: At 12 months follow-up
Thyroid function
Measured: At 12 months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startFeb 2006
- Primary completionApr 2009
- Study completionSep 2009
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 Nodular GoiterStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steen Bonnema
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steen Bonnema, Odense University Hospital
- Investigators
- Steen J. Bonnema, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275171
- Sponsor's protocol ID
- 019
- Status last verified
- Dec 2013
- First submitted
- 9 Jan 2006
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huo Y, Xie J, Chen S, Wang H, Ma C. Recombinant human thyrotropin (rhTSH)-aided radioiodine treatment for non-toxic multinodular goitre. Cochrane Database Syst Rev. 2021 Dec 28;12(12):CD010622. doi: 10.1002/14651858.CD010622.pub2.
PubMed 34961921Fast S, Hegedus L, Grupe P, Nielsen VE, Bluhme C, Bastholt L, Bonnema SJ. Recombinant human thyrotropin-stimulated radioiodine therapy of nodular goiter allows major reduction of the radiation burden with retained efficacy. J Clin Endocrinol Metab. 2010 Aug;95(8):3719-25. doi: 10.1210/jc.2010-0634. Epub 2010 Jun 2.
PubMed 20519346
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 0.1 mg Recombinant Human Thyrotropin (rhTSH) on Thyroid Radioiodine-uptake and the Degree of Goiter Reduction Following 131I-therapy, in Patients With Benign Non-toxic Nodular Goiter. A Randomized, Double-blind, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT00275171
- Acronym / sponsor ID
- 019
- Conditions
- Nodular Goiter
- Keywords
- Nontoxic nodular goiter, 131I therapy, thyroid radioiodine uptake, optimal time-interval, reduced 131I activity, goiter reduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Steen BonnemaUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Jan 2006 (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 study aims at clarifying (in a randomized, double-blinded design):
- Whether stimulation with 0.1 mg rhTSH 24, 48 or 72 hours before induction of a 131I-tracer dosis increases the 131I uptake in patients with atoxic multinodular goitre and to study which time interval is the most optimal (Part I)
- Whether patients suffering from atoxic multinodular goitre obtains a corresponding goitre reduction compared with a control group when stimulating with 0.1 mg rh TSH 24, 48 or 72 hours before 131I therapy and when reducing the thyroid radiation dose to 50 Gy (Part II)
The two studies will be carried out successively on the same patient population. The 131I uptake will be carried out first followed by the I therapy itself. The patients are compared with a placebo-treated control group going through the same course of treatment, but the 131I dosis will be 100 Gy (standard treatment). After the 131I therapy, all patients are followed during one year with a regular ultrasound scan of the thyroid gland and control of the metabolic status. The patient satisfaction is monitored by the use of a visual-analogue-scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhTSH | Active comparator | Drug: Recombinant human thyrotropin (Thyrogen), Drug: recombinant human TSHproceeded by 0.1 mg rhTSH |
| Placebo | Placebo comparator | Other: isotonic saline = placebo1 ml isotonic saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years
- Apart from benign non-toxic goiter no other serious illness
- Signed proof of participation
Key exclusion criteria (11 listed)
- Treatment with Levothyroxine
- Former 131I-therapy
- A thyroid volume above 100 ml or a retro-clavicular component
- Unsafe contraception
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Recombinant human thyrotropin (Thyrogen)0.1 mg rhTSH administered intramuscularly | Drug | rhTSH |
| recombinant human TSH0.1 mg rhTSH administered intramuscularly | Drug | rhTSH |
| isotonic saline = placebo0.1 mg isotonic saline injected intramuscularly | Other | Placebo |
Primary outcome
An intra-individual comparison of the thyroid 131I-uptake before and after stimulation with rhTSH /placebo
Time frame: 24 and 96 hours after tracer administration
An inter-individual comparison of the thyroid 131I uptake between those who receive placebo and those who receive rhTSH
Time frame: 24 and 96 hours after tracer administration
An estimation of which time-interval, injecting rhTSH, that is more favourable before 131I therapy (24 hours, 48 hours or 72 hours)
Time frame: 24 and 96 hours after tracer administration
A comparison of the degree of goiter reduction when patients are prestimulated with rhTSH and receive a thyroid 131I dose of 50 Gy or when receiving conventional 131I, receiving a thyroid dose of 100 Gy
Time frame: 3, 6, 9 and 12 months after 131I therapy
4 secondary outcomes
A registration of adverse effects following rhTSH/placebo
Time frame: All adverse effects occuring within one year follow-up
Patient satisfaction (Visual Analogue Scale) before, 3 months post 131I therapy, and at the end of follow-up (1 year).
Time frame: baseline, 3 and 12 months after 131I therapy
Development of TPOab or TSHRab
Time frame: At 12 months follow-up
Thyroid function
Time frame: At 12 months follow up.
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 4 Dec 2013.
- Derived from this study: PubMed 34961921Huo Y, Xie J, Chen S, Wang H, Ma C. Recombinant human thyrotropin (rhTSH)-aided radioiodine treatment for non-toxic multinodular goitre. Cochrane Database Syst Rev. 2021 Dec 28;12(12):CD010622. doi: 10.1002/14651858.CD010622.pub2.
- Derived from this study: PubMed 20519346Fast S, Hegedus L, Grupe P, Nielsen VE, Bluhme C, Bastholt L, Bonnema SJ. Recombinant human thyrotropin-stimulated radioiodine therapy of nodular goiter allows major reduction of the radiation burden with retained efficacy. J Clin Endocrinol Metab. 2010 Aug;95(8):3719-25. doi: 10.1210/jc.2010-0634. Epub 2010 Jun 2.
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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.
Steen J. Bonnema, MD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant human thyrotropin (Thyrogen) and recombinant human TSH in people with Nodular Goiter, run by Steen Bonnema at 1 site in Denmark.
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 11 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 4 Dec 2013. 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 Denmark. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
An intra-individual comparison of the thyroid 131I-uptake before and after stimulation with rhTSH /placebo (time frame: 24 and 96 hours after tracer administration). The study lists 4 primary outcomes in all. 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 NCT00275171, 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 4 Dec 2013.