Iodine I 131 in Treating Patients With Thyroid Cancer
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.
Head and Neck Cancer
Procedure: computed tomography
Procedure: radionuclide imaging
Procedure: single photon emission computed tomography
Radiation: iodine I 131
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Dose-Response in Radionuclide Therapy of Thyroid Cancer|
- Relationship between estimated absorbed dose and normal organ toxicity [ Time Frame: July '06 to Sept '10 ] [ Designated as safety issue: Yes ]
- Difference in the dose-response relationship between dosimetric methodologies [ Time Frame: July '06 to Sept '10 ] [ Designated as safety issue: No ]
- Influence of prior therapy on the dose-response relationship for hematologic toxicity [ Time Frame: July '06 to Sept '10 ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2006|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
|No Intervention: 1||Procedure: computed tomography Procedure: radionuclide imaging Procedure: single photon emission computed tomography Radiation: iodine I 131|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416949
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||George Sgouros, PhD||Sidney Kimmel Comprehensive Cancer Center|