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Studies on Tumors of the Thyroid
This study is currently recruiting participants.
Study NCT00001160   Information provided by National Institutes of Health Clinical Center (CC)
First Received: November 3, 1999   Last Updated: July 23, 2009   History of Changes

November 3, 1999
July 23, 2009
May 1977
 
 
Determine the feasibility of using PET scanning methodologies with sestamibi.
Complete list of historical versions of study NCT00001160 on ClinicalTrials.gov Archive Site
 
Evaluate Pgp reversal in patients receiving the Pgp antagonist tariquidar.
 
Studies on Tumors of the Thyroid
Studies on Thyroid Nodules and Thyroid Cancer

Participants in this study will be patients diagnosed with or suspected to have a thyroid nodule or thyroid cancer.

The main purpose of this study is to further understand the methods for the diagnosis and treatment of thyroid nodules and thyroid cancer. Many of the test performed are in the context of standard medical care that is offered to all patients with thyroid nodules or thyroid cancer. Other tests are performed for research purposes. In addition, blood and tissue samples will be taken for research and genetic studies.

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 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.

 
Observational
 
  • Neoplasm Metastasis
  • Thyroid Neoplasm
  • Thyroid Nodule
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
99999999
 
 
  • 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.

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;
  2. Patients unable or unwilling to give informed consent
Both
 
No
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010
United States
 
NCT00001160
 
770096, 77-DK-0096
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 
 
National Institutes of Health Clinical Center (CC)
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP