Iodine I 131 in Treating Patients With Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00416949
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : August 7, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center

Brief Summary:

RATIONALE: Radioactive iodine kills thyroid cancer cells by giving off radiation.

PURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I 131 works in treating patients with thyroid cancer.

Condition or disease Intervention/treatment
Head and Neck Cancer Procedure: computed tomography Procedure: radionuclide imaging Procedure: single photon emission computed tomography Radiation: iodine I 131

Detailed Description:


  • Determine the relationship between estimated absorbed dose of iodine I 131 and tumor response or normal organ toxicity for different dosimetric measures, using data derived from clinical radionuclide therapy studies in patients with thyroid cancer.

OUTLINE: Patients receive oral dosimetric iodine I 131 (^131I) on day 2 and then undergo nuclear medicine imaging at 0.5-4 hours, 24, 48, and 72 hours after dosimetric ^131I. Single-photon emission computed tomography (SPECT)/CT scans are performed at 0.5-4 hours and 24 or 48 hours over the head and neck region, including the salivary glands. Subsequent SPECT/CT scans are performed over the candidate tumor sites. Patients undergo ^131I therapy on day 11.

Saliva is collected on days 1 and 2, weeks 2 and 4, and months 3 and 6 to measure saliva flow rate. Blood is collected at baseline and periodically during study to measure FLT3 ligand levels.

PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Dose-Response in Radionuclide Therapy of Thyroid Cancer
Study Start Date : April 2006
Primary Completion Date : October 2009
Study Completion Date : October 2009

Arm Intervention/treatment
No Intervention: 1 Procedure: computed tomography Procedure: radionuclide imaging Procedure: single photon emission computed tomography Radiation: iodine I 131

Primary Outcome Measures :
  1. Relationship between estimated absorbed dose and normal organ toxicity [ Time Frame: July '06 to Sept '10 ]

Secondary Outcome Measures :
  1. Difference in the dose-response relationship between dosimetric methodologies [ Time Frame: July '06 to Sept '10 ]
  2. Influence of prior therapy on the dose-response relationship for hematologic toxicity [ Time Frame: July '06 to Sept '10 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of thyroid cancer
  • Measurable disease by CT scan or nuclear medicine imaging
  • Eligible, by standard of care criteria, for iodine I 131 therapy


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective non-barrier method contraception (e.g., combined or progesterone-only oral contraceptive pill, intrauterine device, depot progesterone, or stable relationship with a partner who has had a vasectomy)
  • No other malignancy within the past 5 years except squamous cell or basal cell carcinoma of the skin
  • No nonthyroidal conditions known to affect iodine I 131 uptake (e.g., New York Heart Association class III or IV congestive heart failure or renal failure)
  • No alcoholism or drug abuse within the past 2 years
  • No severe emotional, behavioral, or psychiatric problems that would preclude study compliance (e.g., severe claustrophobia)


  • No intravenous water-soluble radiographic contrast within the past 4 weeks
  • No iodinated contrast agent within the past 3 months
  • No concurrent drugs that may affect thyroid or renal function (e.g., renal drugs, lithium, amiodarone, other iodine-containing medication, or corticosteroids)
  • No other concurrent investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00416949

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: George Sgouros, PhD Sidney Kimmel Comprehensive Cancer Center

Responsible Party: Sidney Kimmel Comprehensive Cancer Center Identifier: NCT00416949     History of Changes
Other Study ID Numbers: JHOC-J0628
CDR0000522716 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: December 28, 2006    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: May 2013

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
anaplastic thyroid cancer
insular thyroid cancer
thyroid gland medullary carcinoma
recurrent thyroid cancer
stage I follicular thyroid cancer
stage I papillary thyroid cancer
stage II follicular thyroid cancer
stage II papillary thyroid cancer
stage III follicular thyroid cancer
stage III papillary thyroid cancer
stage IVA follicular thyroid cancer
stage IVB follicular thyroid cancer
stage IVC follicular thyroid cancer
stage IVA papillary thyroid cancer
stage IVB papillary thyroid cancer
stage IVC papillary thyroid cancer

Additional relevant MeSH terms:
Thyroid Diseases
Head and Neck Neoplasms
Thyroid Neoplasms
Endocrine System Diseases
Neoplasms by Site
Endocrine Gland Neoplasms
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Growth Substances
Physiological Effects of Drugs