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A Dosimetry Study of Radioiodine (131-I) Uptake Following the Administration of Thyrogen and Hypothyroid States During Thyroid Hormone Withdrawal

Phase 4
Not Enrolling
Hypothyroidism, Thyroid Neoplasms

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Trial Information

A Dosimetry Study of Radioiodine (131-I) Uptake Following the Administration of Thyrogen and Hypothyroid States During Thyroid Hormone Withdrawal

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.

Inclusion Criteria

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

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.

Type of Study:


Study Design:

Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

December 1997

Completion Date:

April 2000

Related Keywords:

  • Hypothyroidism
  • Thyroid Neoplasms
  • Ablation
  • Activity-Time Curves
  • Iodine Biokinetics
  • Thyroid Carcinoma
  • Thyroid Remnant
  • Neoplasms
  • Thyroid Neoplasms
  • Hypothyroidism
  • Thyroid Diseases



National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Bethesda, Maryland  20892