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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Device: Patient-specific dosimetry Not Applicable

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.


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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


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.
Device: Patient-specific dosimetry
Patient-specific 3D-RD dosimetry was applied to the data collected




Primary Outcome Measures :
  1. Tumor Absorbed Dose [ Time Frame: up to 4 years ]
    Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Investigators
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Study Chair: George Sgouros, PhD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00416949     History of Changes
Other Study ID Numbers: J0628
CDR0000522716 ( Registry Identifier: PDQ (Physician Data Query) )
R01CA116477-01A1 ( U.S. NIH Grant/Contract )
NA_00002264 ( Other Identifier: JHM IRB )
First Posted: December 28, 2006    Key Record Dates
Results First Posted: July 18, 2018
Last Update Posted: July 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
thyroid gland medullary carcinoma
anaplastic thyroid cancer
insular thyroid cancer
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
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms