Clinical trial · Interventional
Comparison of I-124 PET/CT for the Diagnosis of Thyroid Cancer
Comparison of I-124 PET/CT to I-123 Whole Body Imaging for the Diagnosis of Thyroid
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Persons diagnosed with thyroid cancer are often treated initially with a thyroidectomy, which is followed by ablation using Iodine-131, a therapy which has been shown to be effective and safe. Imaging of metastatic thyroid cancer has been performed with whole body I-131 and Iodine 123 (I-123) imaging for many decades and use I-123 for staging studies. Iodine 124 (I-124) is a radioisotope of iodine which emits a positron and is imaged using PET (positron emission tomography). This is a single arm prospective trial that evaluates the ability of Iodine-124 (I-124) to detect metastatic thyroid cancer compared to non-interventional, usual care I-123 and I-131 images.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iodine-124 | Drug | — | UNRESOLVED |
| Positron Emission Tomography (PET)/Computerized tomography (CT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention: I-124 PET/CT
- description
- All participants will be administered an oral dose of 60 to 85 megabecquerel (MBq) +/- 10% for I-124 (capsule) prior to the Positron Emission Tomography (PET) imaging. Scan coverage will extend from the vertex to the mid-thighs and in certain circumstances, coverage may be extended to the toes. Imaging will be acquired 20-28 hours after I-124 administered. Participants will be followed up for any adverse events for up to 5 days after the scan has been completed.
- interventionNames
- Drug: Iodine-124
- Procedure: Positron Emission Tomography (PET)/Computerized tomography (CT)
Primary outcomes (2)
- measure
- Proportion of agreement between I-124 PET and I-123/I-131 SPECT (participant)
- timeFrame
- 1 day
- description
- Participant-level agreement between I-124 PET and the combination of I-123/I-131 SPECT will be measured. A participant will be classified as showing agreement only if all six regions demonstrate agreement; disagreement in one or more regions will result in a classification of disagreement. Positive percent agreement (PPA) and negative percent agreement (NPA) will be reported with corresponding 95% confidence intervals.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>= 13 years. 2. Histopathologically confirmed differentiated or poorly differentiated thyroid cancer. 3. Meeting criteria for one of the following two populations: 1. American Thyroid Association (ATA) intermediate or high-risk thyroid cancer and planning on treatment using I-131. 2. Metastatic disease on imaging (CT, MRI, ultrasound or FDG PET), and considering localized therapy such as surgery and radiation therapy. 4. Undergone total thyroidectomy. 5. Planned I-123 imaging within 45 days after enrollment. 6. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1. Unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation. 2. Known pregnancy.
References
Publications (0)
Data not yet available