Trial Information

Studies on Thyroid Nodules and Thyroid Cancer

The purpose of this study is to evaluate methods for preoperative diagnosis and therapy of
thyroid cancer and to screen patients for participation in other protocols. Study subjects
will include adults and children with thyroid nodules or cancer requiring diagnostic fine
needle aspiration biopsy, surgery, radioiodine scanning or therapy for persistent or
recurrent disease.

In this natural history protocol, the use of methods for follow-up of patients using
radiopharmaceutical tracers such as (131)I, (123)I, (201)T1 chloride, (99)mTc-Sestamibi,
(111)Inpentetreotide and 18-FDG PET will be evaluated. All radionuclides will be
administered according to standard clinical practice indications and published guidelines.
The limitations and significance of serum thyroglobulin (Tg) measurement for diagnosing
tumor recurrence will be assessed. The study will permit a continued evaluation of the
risk/benefit ratio of already established methods of administering (131)I therapy including
the impact of pre-treatment dosimetric calculations and administration of lithium (a well
established, yet not widely used, adjuvant to (131)I treatment), especially in selected
cases of thyroid cancer in which high-dose (greater than 150mCi) (131)I therapy is
clinically indicated.

Under this protocol, samples of benign nodules and cancer tissue specimens for research
studies will be collected to assess new immunohistochemical markers, and other techniques to
characterize tumors for correlation with response to therapy and prognosis. Blood and urine
specimens will be collected for future clinical and research studies in both the hypothyroid
and euthyroid state. Coded clinical data will be entered in the National Thyroid Cancer
Registry in selected patients.