Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comparison of Iodine-124 (I-124) and Iodine-131 (I-131) Radiopharmacokinetics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Washington Hospital Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
IBA
Information provided by:
Washington Hospital Center
ClinicalTrials.gov Identifier:
NCT00926978
First received: June 17, 2009
Last updated: August 15, 2011
Last verified: August 2011
  Purpose

This research study is to compare the radiopharmacokinetics of I-124 to the radiopharmacokinetics of I-131 in patients who have well-differentiated thyroid cancer after recombinant human thyroid-stimulating hormone (rhTSH) injection. I-131 is routinely used for imaging and dosimetry for patients with well-differentiated thyroid cancer. In this study, I-124 is administered orally in capsular form, and the radiopharmacokinetics of I-124 is compared with I-131. I-124 is another isotope of iodine, which is cyclotron-produced. I-124 has multiple advantages:

  • Ideal Half-Life (4.2 days) for delayed imaging.
  • High resolution tomographic imaging.
  • Feasibility of quantitating lesion uptake.
  • Potential of dosimetry for the planning of radioiodine therapy.

Voluntary patients will have I-124 dosimetry performed in addition to the I-131 dosimetry, which is planned as part of routine clinical care. I-124 dosimetry is composed of four parts: (1) two extra doses of injections of rhTSH, (2) the administration of I-124, (3) PET imaging, and (4) drawing blood samples.

Patients will receive two additional injections of rhTSH. This is similar to the procedure for I-131 dosimetry. Second, they will receive I-124. I-124 is similar to I-131 except I-124 decays in a different way to emit a positron so that the PET scanner can be used for imaging. I-124 is given in the form of one or several capsules, which are taken by mouth. This is also similar to I-131. Third, PET/CT imaging is done for approximately 30 minutes to one hour on five consecutive days. Radiation from PET/CT scan is far less than what they receive from a diagnostic CT scan. For the fourth part, a technologist will draw about 5 cc from the forearm on each of the five consecutive days. This is also similar to I-131.

Initially, all patients will be randomized to one of two study groups. The first group will have the I-131 dosimetry performed first followed by the I-124 dosimetry, and the second group will have the I-124 dosimetry performed first followed by the I-131 dosimetry.

The risk of this study is considered very low, and the potential benefits to the patient are considered very high.


Condition Intervention
Thyroid Cancer
Radiation: Radioactive Iodine 124

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Comparison of I-124 and I-131 Radiopharmacokinetics in Patients Who Have Well-differentiated Thyroid Cancer and Are Prepared With Recombinant Human TSH Injection (rhTSH)

Resource links provided by NLM:


Further study details as provided by Washington Hospital Center:

Primary Outcome Measures:
  • Compare the measurement of radioiodine uptake and clearance in suspected metastatic foci of well-differentiated thyroid cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2008
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Radioactive Iodine 124

    After TSH stimulation with Recombinant human TSH (rhTSH) for 2 days, a dose of radioactive iodine 124 ( I-124) 1.7 mCi is administrated orally and PET imaging is done for 5 continuous days including the day of the dose administration. On each day, just before imaging, 5 ml of blood is drawn.

    Patients will be randomized to either the sequence above (e.g. I-131 followed by I-124) or to the reverse sequence in which the I-124 is given first followed by the I-131. If I-124 is administered first and as long as the whole body retention is < 2% by the start of the second rhTSH stimulation, the I-124 will not interfere with the I-131.

    Other Name: Official name for I-124: "Sodium [124I] iodide solution in 0.02 N aqueous NaOH"
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Well-differentiated thyroid carcinoma
  • Referred for I-131 dosimetry
  • Preparation with Recombinant Human TSH (rh TSH)

Exclusion Criteria:

  • < 18 years of age
  • Pregnancy or breast feeding
  • Inability to comply with instructions
  • Simultaneous participation or participation in any other research study within the last month
  • A body weight greater than 350 lbs
  • A creatinine > 1.5 mg/ml for males and 1.4 mg/ml for females
  • Preparation with thyroid hormone withdrawal(THW)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926978

Contacts
Contact: Dougals Van Nostrand, MD 202 877 0348 douglas.van.nostrand@medstar.net
Contact: Boris A Frolov, MD 202 877 6094 boris.a.frolov@medstar.net

Locations
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Douglas Van Nostrand, MD    202-877-0348    douglas.van.nostrand@medstar.net   
Contact: Boris A Frolov, MD    202 877 6094    boris.a.frolov@medstar.net   
Sponsors and Collaborators
Washington Hospital Center
Genzyme, a Sanofi Company
IBA
Investigators
Principal Investigator: Douglas Van Nostrand, MD Director, Nuclear Medicine
  More Information

No publications provided

Responsible Party: Douglas Van Nostrand, MD, Director, Division of Nuclear Medicine, Washington Hospital Center
ClinicalTrials.gov Identifier: NCT00926978     History of Changes
Other Study ID Numbers: 2008-292
Study First Received: June 17, 2009
Last Updated: August 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington Hospital Center:
Thyroid
I-124

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Iodine
Anti-Infective Agents
Anti-Infective Agents, Local
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on November 20, 2014