- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00416949
Iodine I 131 in Treating Patients With Thyroid Cancer
Dose-Response in Radionuclide Therapy of 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Diagnosis of thyroid cancer
- Measurable disease by CT scan or nuclear medicine imaging
- Eligible, by standard of care criteria, for iodine I 131 therapy
PATIENT CHARACTERISTICS:
- 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)
PRIOR CONCURRENT THERAPY:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Patient-specific 3D-RD dosimetry was applied to the data collected
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor Absorbed Dose
Time Frame: up to 4 years
|
Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.
|
up to 4 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: George Sgouros, PhD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- anaplastic thyroid cancer
- thyroid gland medullary carcinoma
- recurrent thyroid cancer
- insular thyroid cancer
- stage II follicular thyroid cancer
- stage II papillary thyroid cancer
- stage I follicular thyroid cancer
- stage I 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
Other Study ID Numbers
- J0628
- CDR0000522716 (Registry Identifier: PDQ (Physician Data Query))
- R01CA116477-01A1 (NIH)
- NA_00002264 (Other Identifier: JHM IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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