Comparison of Iodine-124 (I-124) and Iodine-131 (I-131) Radiopharmacokinetics in Patients Prepared With Recombinant Human TSH Injection (rhTSH)

NCT00926978 | Terminated DMC

• 1 other identifier: 2008-292
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Cancer

Keywords

Thyroid; I-124

Outcome Measures

Primary Outcomes (1)

• Compare the measurement of radioiodine uptake and clearance in suspected metastatic foci of well-differentiated thyroid cancer

  2 years

Study Arms (1)

Radiopharmacokinetics

OTHER

1-2 mCi I-124 orally, once per day, twice total 0.9mg rhTSH intravenous injection, once per day, four total 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.

Radiation: Radioactive Iodine 124

Interventions

Radioactive Iodine 124 RADIATION

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.

Also known as: Sodium [124I] iodide solution in 0.02 N aqueous NaOH

Radiopharmacokinetics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \< 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)

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Diseases

Interventions

Sodium

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Douglas Van Nostrand, MD

  Director, Nuclear Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Nuclear Medicine Research

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 24, 2009
• Study Start: December 1, 2008
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 1, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)