Clinical trial · Interventional
Comparison of I-124 and I-131 Radiopharmacokinetics in DTC Patients With Thyroid Hormone Withdrawal
Comparison of I-124 and I-131 Radiopharmacokinetics In Patient With Well Differentiated Thyroid Cancer After Thyroid Hormone Withdrawal
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Institutional RDRC dissolved
Summary
Brief summary (as posted)
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 thyroid hormone withdrawal. 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 three parts: (1) the administration of I-124, (2) imaging, and (3) drawing blood samples. Patients will start 3-5 weeks of thyroid hormone withdrawal. 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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radioactive Iodine 124 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- I-124 in thyroid hormone withdrawal
- description
- After thyroid hormone withdrawal for 3-5 weeks, 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.
- interventionNames
- Radiation: Radioactive Iodine 124
Primary outcomes (1)
- measure
- Compare the measurement of radioiodine uptake and clearance in suspected metastatic foci of well-differentiated thyroid cancer
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older, * Well-differentiated thyroid carcinoma, * Referred for 131-I dosimetry, * Suspected of having metastases, which includes but is not limited to elevated TG without antibodies, clinical mass suggestive of metastases, radiographic finding on CT, MR, PET, and/or ultrasound, etc. suggestive of metastases, etc., and * Preparation for dosimetry and treatment planned with thyroid hormone withdrawal. Exclusion Criteria: * \< 18 years of age, * Pregnancy or breast feeding, * Inability to comply with instructions, * In ability to tolerate hypothyroidism as determined by the opinion of the referring endocrinologist, * Simultaneous participation or participation in any other research study within the last month, * A body weight greater than 350 lbs., and/or * A creatinine \> 1.5 mg/ml for males and 1.4 mg/ml for females.
References
Publications (0)
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