Iodine I 131 in Treating Patients With Thyroid Cancer

Study Overview
=================
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.

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.

Official Title
-----------------
Dose-Response in Radionuclide Therapy of Thyroid Cancer

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Device: Patient-specific dosimetry


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient-specific 3D-RD Dosimetry<br>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<br>* Patient-specific 3D-RD dosimetry was applied to the data collected<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Absorbed Dose | Tumor absorbed doses (Gy) calculated using patient-specific dosimetry. | up to 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anaplastic thyroid cancer, insular thyroid cancer, thyroid gland medullary carcinoma, recurrent thyroid cancer, stage I follicular thyroid cancer, stage I papillary thyroid cancer, stage II follicular thyroid cancer, stage II 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