HypothyroidismPhase 4NCT00001730
Study of Radioiodine (131-I) Uptake Following Administration of Thyrogen and Hypothyroid States During Thyroid Hormone Withdrawal.
A Phase 4 study testing Thyrogen in people with Hypothyroidism and Thyroid Neoplasms, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Thyroid cancer is typically treated with surgery, radiation or a combination of both. Following surgical removal of thyroid tissue patients receive thyroid hormone replacement medication. In addition patients undergo tests to determine the status of the disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypothyroidism, Thyroid Neoplasms
- What is being tested?
- Thyrogen
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1997to Apr 2000
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Patients greater than or equal to 18 years of age, with well-differentiated, non-medullary thyroid cancer, including papillary (including follicular-variant), follicular, and Hurthle cell.
Patients who recently have undergone a total or near-total thyroidectomy and are scheduled to undergo initial 131I diagnostic studies and ablation.
Patients must have evidence of residual thyroid tissue after thyroid surgery confirmed by ultrasound or other imaging technique (e.g., a technetium [Tc 99] pertechnetate or thallium scan).
Patients who have undergone thyroidectomy or other thyroid surgery at least 6 weeks prior to enrollment.
All patients who have been sustained on maintenance THST for at least 4 weeks, but not longer than 12 weeks after thyroidectomy.
All patients who have confirmed serum TSH levels less than or equal to 0.5 mU per liter within 7 days prior to the first Thyrogen dose, and prior to randomization.
Female patients of childbearing age must have a negative serum human chorionic gonadotropin (HCG) pregnancy test prior to entering the study and within 5 days of any 131I administration and must be following an approved method of contraception.
Patients who are committed to following the protocol requirements as evidenced by providing written informed consent.
Patients for whom a 131I scan is currently contraindicated because withdrawal from THST is not an option due to pituitary dysfunction or other compelling medical reasons are excluded.
Patients should not have a concurrent major medical disorder (e.g., documented cardiac disease, debilitating cardiopulmonary disease, advanced renal failure, advanced liver disease or advanced pulmonary disease) who may be too ill to adequately comply with the requirements of this study.
Patients with non-thyroidal conditions known to effect 131I uptake (e.g., congestive heart failure, renal failure) are excluded.
Patients should not have undergone any intravenous water soluble radiographic contrast administration within the previous 4 weeks.
Patients should not have received intrathecal or cholecystographic iodinated contrast agent administration within 3 months prior to enrollment.
Patients should not be taking drugs that affect thyroid or renal function (e.g., renal drugs, lithium, or corticosteroids).
Patients should not be participating in another investigational drug study or in such a study within 30 days of their enrollment in this study.
No patients with a recent history of alcoholism or drug abuse, severe emotional behavioral or psychiatric problems who, in the opinion of the investigator, would not be able to comply with the requirements of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, 20892
About this study
Official title: A Dosimetry Study of Radioiodine (131-I) Uptake Following the Administration of Thyrogen and Hypothyroid States During Thyroid Hormone Withdrawal
Thyroid cancer is typically treated with surgery, radiation or a combination of both. Following surgical removal of thyroid tissue patients receive thyroid hormone replacement medication. In addition patients undergo tests to determine the status of the disease. One of the tests conducted is a whole body scan using radioactive iodine to detect and locate any remaining cancerous thyroid tissue.
Thyroid tissue uses iodine to make thyroid hormones (T3 and T4). In order for a radioiodine scan to work, cancerous thyroid tissue must be "hungry" for iodine. Thyroid stimulating hormone (TSH) produced in the pituitary gland is responsible for making thyroid tissue "hungry" for iodine. Once thyroid tissue absorbs the radioactive iodine it will be clearly visible on the scan and can be located for removal. However, thyroid hormone replacement medication tends to lower the activity of the pituitary gland and the amount of naturally produced TSH. So it is necessary to stop thyroid hormone replacement to increase TSH. A problem arises when there is a lack of thyroid hormone replacement causing patients to experience hypothyroidism. This condition is associated with unpleasant physical and emotional symptoms.
Read more
TSH has been created in a laboratory and called Thyrogen. It is basically the same as the TSH produced in the human pituitary gland. However, Thyrogen increases the level of TSH in the body without having to stop thyroid replacement medication. Therefore patients will not experience hypothyroidism while preparing for a radioactive iodine scan.
The objective of this study is to compare the activity of radioiodine (131I) in patients taking Thyrogen with normal thyroid activity versus patients with hypothyroid activity after thyroid replacement medication is withdrawn. In addition the study will provide information on how radioactive iodine is eliminated from the body. The study will help researchers understand how to give Thyrogen and radioiodine for purposes of scanning and therapeutic ablation (the destruction of function) of cancerous thyroid tissue.
The study will accept patients with non-medullary thyroid cancer who are preparing for ablation therapy. The patients will be placed in one of two groups. Group one will receive Thyrogen in 2 doses 24 hours apart. Group two will receive Thyrogen in 3 doses 72 hours apart. The patients will undergo two 131I whole body scans: one after Thyrogen while taking thyroid hormone suppressive and the second after withdrawal from thyroid hormone. 131I ablative therapy will be given under hypothyroid conditions at the completion of the study.
Read the detailed description
This is a multi-centered, open-labeled, randomized, two parallel-arm study designed to compare quantitative radiation dosimetry assessments obtained during thyroid hormone suppression therapy with recombinant human TSH (Thyrogen® (Registered Trademark)) and hypothyroidism in thyroid cancer patients preparing for post-surgical radioiodine ablation. The primary endpoint of this study is to identify the ratio of administered activity of radioiodine (131I) to deliver a targeted dose of 30,000 rad to the thyroid remnant when patients are euthyroid on Thyrogen® (Registered Trademark) and hypothyroid after hormone withdrawal. Secondary endpoints are to identify and compare effective 131I clearance and cumulated activity in the whole body and blood during euthyroid and hypothyroid states.
All adult patients with differentiated non-medullary thyroid cancer who are preparing for ablation therapy are eligible for participation. Patients will be randomized to one of two different dosing regimens of Thyrogen® (Registered Trademark). Participants will undergo two 131I whole body scans: one after Thyrogen® (Registered Trademark) while taking thyroid hormone suppressive therapy and the second after withdrawal from thyroid hormone. 131I ablative therapy will be given under hypothyroid conditions at the completion of the dosimetry study.
- Conditions
- Hypothyroidism, Thyroid Neoplasms
- Being tested
- Thyrogen
- Keywords
- Ablation, Activity-Time Curves, Iodine Biokinetics, Thyroid Carcinoma, Thyroid Remnant
- Medical subject headings
- Hypothyroidism, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThyrogenDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startDec 1997
- Study completionApr 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Enrolment
- 20 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001730
- Sponsor's protocol ID
- 980038
- Other IDs
- 98-DK-0038
- Status last verified
- Nov 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Montenegro J, Gonzalez O, Saracho R, Aguirre R, Gonzalez O, Martinez I. Changes in renal function in primary hypothyroidism. Am J Kidney Dis. 1996 Feb;27(2):195-8. doi: 10.1016/s0272-6386(96)90539-9.
PubMed 8659492Maxon HR 3rd, Smith HS. Radioiodine-131 in the diagnosis and treatment of metastatic well differentiated thyroid cancer. Endocrinol Metab Clin North Am. 1990 Sep;19(3):685-718.
PubMed 2261912Wong JB, Kaplan MM, Meyer KB, Pauker SG. Ablative radioactive iodine therapy for apparently localized thyroid carcinoma. A decision analytic perspective. Endocrinol Metab Clin North Am. 1990 Sep;19(3):741-60.
PubMed 2261914
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dosimetry Study of Radioiodine (131-I) Uptake Following the Administration of Thyrogen and Hypothyroid States During Thyroid Hormone Withdrawal
- ClinicalTrials.gov ID
- NCT00001730
- Acronym / sponsor ID
- 980038
- Conditions
- Hypothyroidism, Thyroid Neoplasms
- Keywords
- Ablation, Activity-Time Curves, Iodine Biokinetics, Thyroid Carcinoma, Thyroid Remnant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Dec 1997
- Study completion
- Apr 2000
- First posted
- 10 Dec 2002 (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.
Thyroid cancer is typically treated with surgery, radiation or a combination of both. Following surgical removal of thyroid tissue patients receive thyroid hormone replacement medication. In addition patients undergo tests to determine the status of the disease. One of the tests conducted is a whole body scan using radioactive iodine to detect and locate any remaining cancerous thyroid tissue.
Thyroid tissue uses iodine to make thyroid hormones (T3 and T4). In order for a radioiodine scan to work, cancerous thyroid tissue must be "hungry" for iodine. Thyroid stimulating hormone (TSH) produced in the pituitary gland is responsible for making thyroid tissue "hungry" for iodine. Once thyroid tissue absorbs the radioactive iodine it will be clearly visible on the scan and can be located for removal. However, thyroid hormone replacement medication tends to lower the activity of the pituitary gland and the amount of naturally produced TSH. So it is necessary to stop thyroid hormone replacement to increase TSH. A problem arises when there is a lack of thyroid hormone replacement causing patients to experience hypothyroidism. This condition is associated with unpleasant physical and emotional symptoms.
TSH has been created in a laboratory and called Thyrogen. It is basically the same as the TSH produced in the human pituitary gland. However, Thyrogen increases the level of TSH in the body without having to stop thyroid replacement medication. Therefore patients will not experience hypothyroidism while preparing for a radioactive iodine scan.
The objective of this study is to compare the activity of radioiodine (131I) in patients taking Thyrogen with normal thyroid activity versus patients with hypothyroid activity after thyroid replacement medication is withdrawn. In addition the study will provide information on how radioactive iodine is eliminated from the body. The study will help researchers understand how to give Thyrogen and radioiodine for purposes of scanning and therapeutic ablation (the destruction of function) of cancerous thyroid tissue.
The study will accept patients with non-medullary thyroid cancer who are preparing for ablation therapy. The patients will be placed in one of two groups. Group one will receive Thyrogen in 2 doses 24 hours apart. Group two will receive Thyrogen in 3 doses 72 hours apart. The patients will undergo two 131I whole body scans: one after Thyrogen while taking thyroid hormone suppressive and the second after withdrawal from thyroid hormone. 131I ablative therapy will be given under hypothyroid conditions at the completion of the study.
Detailed description
This is a multi-centered, open-labeled, randomized, two parallel-arm study designed to compare quantitative radiation dosimetry assessments obtained during thyroid hormone suppression therapy with recombinant human TSH (Thyrogen® (Registered Trademark)) and hypothyroidism in thyroid cancer patients preparing for post-surgical radioiodine ablation. The primary endpoint of this study is to identify the ratio of administered activity of radioiodine (131I) to deliver a targeted dose of 30,000 rad to the thyroid remnant when patients are euthyroid on Thyrogen® (Registered Trademark) and hypothyroid after hormone withdrawal. Secondary endpoints are to identify and compare effective 131I clearance and cumulated activity in the whole body and blood during euthyroid and hypothyroid states.
All adult patients with differentiated non-medullary thyroid cancer who are preparing for ablation therapy are eligible for participation. Patients will be randomized to one of two different dosing regimens of Thyrogen® (Registered Trademark). Participants will undergo two 131I whole body scans: one after Thyrogen® (Registered Trademark) while taking thyroid hormone suppressive therapy and the second after withdrawal from thyroid hormone. 131I ablative therapy will be given under hypothyroid conditions at the completion of the dosimetry study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 | Drug | – |
Primary outcome
Not reported in the source record.
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 Mar 2008.
- Background: PubMed 8659492Montenegro J, Gonzalez O, Saracho R, Aguirre R, Gonzalez O, Martinez I. Changes in renal function in primary hypothyroidism. Am J Kidney Dis. 1996 Feb;27(2):195-8. doi: 10.1016/s0272-6386(96)90539-9.
- Background: PubMed 2261912Maxon HR 3rd, Smith HS. Radioiodine-131 in the diagnosis and treatment of metastatic well differentiated thyroid cancer. Endocrinol Metab Clin North Am. 1990 Sep;19(3):685-718.
- Background: PubMed 2261914Wong JB, Kaplan MM, Meyer KB, Pauker SG. Ablative radioactive iodine therapy for apparently localized thyroid carcinoma. A decision analytic perspective. Endocrinol Metab Clin North Am. 1990 Sep;19(3):741-60.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thyrogen in people with Hypothyroidism and Thyroid Neoplasms, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001730, which also lists 3 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 Mar 2008.