Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416949
Status:
TERMINATED
Last Update Posted:
2018-07-18
First Post:
2006-12-27
Brief Title:
Iodine I 131 in Treating Patients With Thyroid Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Dose-Response in Radionuclide Therapy of Thyroid Cancer
Status:
TERMINATED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to loss of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
PURPOSE This clinical trial is studying the side effects best dose and how well iodine I 131 works in treating patients with thyroid cancer
Detailed Description:
OBJECTIVES
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 05-4 hours 24 48 and 72 hours after dosimetric 131I Single-photon emission computed tomography SPECTCT scans are performed at 05-4 hours and 24 or 48 hours over the head and neck region including the salivary glands Subsequent SPECTCT 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
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 05-4 hours 24 48 and 72 hours after dosimetric 131I Single-photon emission computed tomography SPECTCT scans are performed at 05-4 hours and 24 or 48 hours over the head and neck region including the salivary glands Subsequent SPECTCT 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NA_00002264 | OTHER | JHM IRB | httpsreporternihgovquickSearchR01CA116477-01A1 |
| CDR0000522716 | REGISTRY | None | None |
| R01CA116477-01A1 | NIH | None | None |