Iodine I 131 in Treating Patients With Thyroid Cancer
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|ClinicalTrials.gov Identifier: NCT00416949|
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : August 7, 2014
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||Phase|
|Head and Neck Cancer||Procedure: computed tomography Procedure: radionuclide imaging Procedure: single photon emission computed tomography Radiation: iodine I 131||Not Applicable|
- 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|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
|No Intervention: 1||
Procedure: computed tomography
Procedure: radionuclide imaging
Procedure: single photon emission computed tomography
Radiation: iodine I 131
- Relationship between estimated absorbed dose and normal organ toxicity [ Time Frame: July '06 to Sept '10 ]
- Difference in the dose-response relationship between dosimetric methodologies [ Time Frame: July '06 to Sept '10 ]
- Influence of prior therapy on the dose-response relationship for hematologic toxicity [ Time Frame: July '06 to Sept '10 ]
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 ClinicalTrials.gov identifier (NCT number): 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 at Johns Hopkins|