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Studies on Thyroid Nodules and Thyroid Cancer

Open (Enrolling)
Neoplasm Metastasis, Thyroid Neoplasm, Thyroid Nodule

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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.

Inclusion Criteria


Adults and children with known or suspected thyroid neoplasm will be considered for
participation. Enrollment will be capped accordingly:

1. Patients with thyroid nodules requiring evaluation and possible biopsy (no more than
30 per year);

2. Patients with recent diagnosis of thyroid cancer requiring consultation and
counseling about therapeutic options (no more than 10 per year);

3. Patients with established thyroid cancer requiring specialized studies such as (131)I
dosimetry (no more than 5 per year);

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


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

2. Patients unable or unwilling to give informed consent

Type of Study:


Study Design:


Principal Investigator

Monica C Skarulis, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)


United States: Federal Government

Study ID:




Start Date:

May 1977

Completion Date:

Related Keywords:

  • Neoplasm Metastasis
  • Thyroid Neoplasm
  • Thyroid Nodule
  • Thyroid
  • Nodules
  • Cancer
  • Clinically Aggressive
  • Radioiodine
  • Dosimetry
  • High Dose Therapy
  • FDG-PET Scanning
  • Fine Needle Aspiration Biopsy
  • Neoplasms
  • Thyroid Neoplasms
  • Neoplasm Metastasis
  • Thyroid Diseases
  • Thyroid Nodule



National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892