- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00275171
rhTSH, Radioiodine Uptake and Goiter Reduction Following 131I Therapy in Patients With Benign Nontoxic Nodular Goiter
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Odense, Denmark, 5000
- Odense University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age over 18 years
- Apart from benign non-toxic goiter no other serious illness
- Signed proof of participation
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: rhTSH
proceeded by 0.1 mg rhTSH
|
0.1 mg rhTSH administered intramuscularly
0.1 mg rhTSH administered intramuscularly
|
Placebo Comparator: Placebo
1 ml isotonic saline
|
0.1 mg isotonic saline injected intramuscularly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
3, 6, 9 and 12 months after 131I therapy
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
A registration of adverse effects following rhTSH/placebo
Time Frame: All adverse effects occuring within one year follow-up
|
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
|
baseline, 3 and 12 months after 131I therapy
|
Development of TPOab or TSHRab
Time Frame: At 12 months follow-up
|
At 12 months follow-up
|
Thyroid function
Time Frame: At 12 months follow up.
|
At 12 months follow up.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steen J. Bonnema, MD, Odense University Hospital
Publications and helpful links
General 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:CD010622. doi: 10.1002/14651858.CD010622.pub2. Review.
- Fast 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nodular Goiter
-
Steen BonnemaCompleted
-
Odense University HospitalCompleted
-
Jan CalissendorffRecruiting
-
Central South UniversityUnknown
-
National Taiwan University HospitalCompleted
-
University Hospital, RouenCompletedGoiter, NodularFrance
-
Bezmialem Vakif UniversityCompleted
-
Castilla-León Health ServiceCompleted
Clinical Trials on Recombinant human thyrotropin (Thyrogen)
-
Odense University HospitalCompletedGraves' Disease | Benign Nontoxic and Toxic GoiterDenmark
-
Genzyme, a Sanofi CompanyCompletedDifferentiated Thyroid CancerUnited States, France, Canada, Germany, Italy
-
Genexine, Inc.SymyooCompletedTotal Thyroidectomy | Near-total ThyroidectomyKorea, Republic of
-
Shandong UniversityShandong Provincial Hospital; The First Affiliated Hospital of Dalian Medical...CompletedImmune ThrombocytopeniaChina
-
Peking Union Medical CollegeShenyang Sunshine Pharmaceutical Co., LTD.UnknownThrombocytopenia | Immune Thrombocytopenia | Idiopathic Thrombocytopenic PurpuraChina
-
Massachusetts General HospitalCompleted
-
Tianjin Medical University General HospitalUnknown
-
Memorial Sloan Kettering Cancer CenterGenentech, Inc.Active, not recruiting
-
Massachusetts General HospitalWithdrawn
-
Hongnan MoUnknownHematopoietic Stem Cell Transplantation | Thrombocytopoietin | Hematopoietic Stem Cell MobilizationChina