Comparison of Iodine-124 (I-124) and Iodine-131 (I-131) Radiopharmacokinetics
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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) |
- 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) |
-
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.
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 |
| 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 | |
| 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 Neoplasms Thyroid Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Endocrine System Diseases Iodine Cadexomer iodine |
Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013