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NCT00926978 · ClinicalTrials.gov registry record · NA
Comparison of Iodine-124 (I-124) and Iodine-131 (I-131) Radiopharmacokinetics in Patients Prepared With Recombinant Human TSH Injection (rhTSH)
A NA study, sponsored by Medstar Health Research Institute.
- Terminated
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT00926978 is a NA study that was terminated before completion, run by Medstar Health Research Institute. The registered enrollment target is 21 participants.
The verdict
NCT00926978, a NA study, was terminated before completion, sponsored by Medstar Health Research Institute.
- TERMINATED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study 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 d
Interventions
- RADIATION Radioactive Iodine 124
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2008-12 |
| Est. Completion | 2018-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00926978
The ClinicalTrials.gov registry entry for NCT00926978 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medstar Health Research Institute, which has 115 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Radioactive Iodine 124 is the first listed.
NCT00926978 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00926978 about?
NCT00926978 is a clinical study titled "Comparison of Iodine-124 (I-124) and Iodine-131 (I-131) Radiopharmacokinetics in Patients Prepared With Recombinant Human TSH Injection (rhTSH)". 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 wit...
What is the current status of trial NCT00926978?
This trial is currently terminated. It is a NA study. The enrollment target is 21 participants. The study started on 2008-12. Estimated completion is 2018-10.
What interventions are being tested in trial NCT00926978?
The interventions under investigation include: Radioactive Iodine 124 (RADIATION).
Who is sponsoring clinical trial NCT00926978?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
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