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.|
|ClinicalTrials.gov Identifier: NCT00416949|
Recruitment Status : Terminated (Study was terminated due to loss of funding.)
First Posted : December 28, 2006
Results First Posted : July 18, 2018
Last Update Posted : July 18, 2018
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||Device: Patient-specific dosimetry||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|
Experimental: Patient-specific 3D-RD Dosimetry
Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.
Device: Patient-specific dosimetry
Patient-specific 3D-RD dosimetry was applied to the data collected
- Tumor Absorbed Dose [ Time Frame: up to 4 years ]Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.
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|