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Dose-Response in Radionuclide Therapy of Thyroid Cancer

18 Years
Not Enrolling
Head and Neck Cancer

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Trial Information

Dose-Response in Radionuclide Therapy of Thyroid Cancer


- 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.

Inclusion Criteria


- Diagnosis of thyroid cancer

- Measurable disease by CT scan or nuclear medicine imaging

- Eligible, by standard of care criteria, for iodine I 131 therapy


- 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)


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Relationship between estimated absorbed dose and normal organ toxicity

Outcome Time Frame:

July '06 to Sept '10

Safety Issue:


Principal Investigator

George Sgouros, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2006

Completion Date:

October 2009

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Thyroid Neoplasms
  • Head and Neck Neoplasms



Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410