Dose-Response in Radionuclide Therapy of Thyroid Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Tumor Absorbed Dose
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Patient-specific dosimetry (Device)
Outcomes
Primary Outcomes
Tumor Absorbed Dose
Time Frame: up to 4 years
Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.
Secondary Outcomes
No secondary outcomes reported