Studies on Tumors of the Thyroid

The purpose of this study is to evaluate methods for preoperative diagnosis and therapy of
differentiated and medullary 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, (99)mTc-Sestamibi, (111)Inpentetreotide
and 18-FDG PET administered according to standard clinical practice indications, and
68Gallium-DOTATATE (Octreotate)-administered per research protocol as indicated. 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 FNAB, benign nodules and cancer tissue specimens, blood
samples for research studies will be collected to assess new immunohistochemical and
molecular markers, and other techniques to characterize tumors for correlation with
diagnosis, 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.

- INCLUSION CRITERIA:

Adults and children with known or suspected thyroid neoplasm will be considered for
participation.

1. Patients with thyroid nodules requiring evaluation and possible biopsy

2. Patients with recent diagnosis of thyroid cancer requiring consultation and counseling
about therapeutic options

3. Patients with established thyroid cancer requiring specialized studies such as (131)I
dosimetry

4. Enrollment of high risk, non-iodine avid, inoperable thyroid cancer for standard
treatment of screening for eligibility for other specific thyroid cancer protocols.

EXCLUSION CRITERIA:

1. Serious underlying medical conditions that restrict diagnostic testing or therapy such
as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma.