Clinical trial · Observational
I-124 PET/CT Imaging and Dosimetry for RAI-Naïve or Refractory Thyroid Cancer
CLINICAL UTILITY AND FEASIBILITY OF I-124 PET/CT IMAGING AND DOSIMETRY IN PATIENTS WITH THYROID CANCER
- 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)
The objective of this study is to demonstrate the clinical utility of I-124 PET/CT imaging and dosimetry in patients with thyroid cancer including 1) Evaluation of extent (volume and pattern) of remnant tissue in post total thyroidectomy setting and distinction of nodal metastases vs remnant tissue for determination of indication for RAI ablation, 2) Evaluation of response to RAI remnant ablation, 3) Evaluation for suspected occult recurrent/metastatic disease, 4) Evaluation of extent of disease in patients with known metastatic disease and 5) Evaluation of RAI avidity of recurrent/metastatic thyroid cancer and response to treatment with thyroid kinase inhibitors (TKI). Patients who underwent total thyroidectomy for thyroid cancers are studied. Patients who are newly diagnosed, as well as those who have known or suspected to have recurrent or metastatic disease are eligible. Patients receiving TKI treatment are eligible for evaluation prior to and after the treatment. The patients who are considered for TKI/MAPK treatments undergo pre and post treatment with clinically determined oncoprotein/TKR therapeutic agent(s), including multi-TKI, selective BRAF, MEK, PI3K or ERK inhibitors or combination treatments.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| RAI-Refractory Thyroid Cancer | Thyroid Gland Neoplasm | PROBABILISTIC | 0.70 |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Disease status detection | Diagnostic Test | — | UNRESOLVED |
| I-124 PET/CT imaging | Drug | — | UNRESOLVED |
| Theranostic dosimetry | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Thyroid Cancer patients, RAI-naive or refractory
- interventionNames
- Diagnostic Test: Disease status detection
- Diagnostic Test: Theranostic dosimetry
- Drug: I-124 PET/CT imaging
Primary outcomes (1)
- measure
- Identification and characterization of RAI uptake pattern and kinetics
- timeFrame
- 5 years
- description
- Measurements: 1. Administered activity 2. Cumulated activity 3. Standard uptake value Calculations: 1\. Radiation absorbed dose to the target Correlations to be reported: 1. Administered activity vs absorbed dose 2. Absorbed dose vs response 3. SUV at 48h vs response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Post-total thyroidectomy patients with diagnosis of thyroid cancer, any histology, subtype, any ATA risk category, for evaluation for residual disease, cervical or remote metastatic disease * Patients with known or suspected recurrent/metastatic thyroid cancer, identified by ultrasound (US), CT/MR/FDG-PET\|CT or elevated thyroglobulin (Tg). * Pretreatment and post-treatment evaluation of patients with thyroid cancer deemed RAI-indifferent/refractory who are considered for TKI * Age ≥ 18 * Ability and willingness to give a written consent * Life expectancy \> 3 months * ECOG performance status ≤ 2 Exclusion Criteria * Cancers metastatic to thyroid * Age \< 18 * Inability or unwillingness to give a written consent * Life expectancy \< 3 months * ECOG performance status ≥ 3 * Pregnant and nursing women.
References
Publications (0)
Data not yet available