Clinical trial · Interventional
Metastatic Thyroid Cancer Therapy Optimization With 124I PET Dosimetry
Personalized Therapy of Metastatic Thyroid Cancer: Biological Characterization and Optimization With 124I PET Dosimetry
NCT05299437CI-TRIAL-00057386131THEROPT124unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Failure of conventional radioiodine therapy of metastatic differentiated thyroid cancer could be explained by: * a suboptimal therapeutic approach, based on the administration of empirically fixed amount of radioactivity * the presence of lesions with impaired iodine uptake, due to the expression of specific mutations The study aims to: * optimize therapy with pre-treatment 124-I blood and lesion dosimetry * collect genetic data to check if specific mutations and/or miRNA over-expression could be related to low iodine uptake or to radioresistance
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 |
|---|---|---|---|
| Metastatic Differentiated Thyroid Cancer | Thyroid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radioiodine optimized therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Optimized therapy
- description
- Patients with ascertained metastatic differentiated thyroid cancer will be studied with FDG PET, CT, and for genetic characterization. 100 MBq of 124-I are administered for blood and PET lesion dosimetry. According Jentzen et al, good efficacy (Tumour Control Probability \> 80%) is obtained with absorbed dose higher than 80 Gy to soft tissue metastases, and \> 650 Gy to bone metastases. These values ae pursued with the limit of 2 Gy to blood. Only soft tissue lesions will be considered as target for the calculation of the complete response rate. However, for ethical reasons, therapeutic activity will be chosen in order to be effective both on soft tissue and bone lesions. Patients with too low predicted lesion absorbed dose even administering the Maximum Tolerable Activity (2 Gy to blood) will exit the protocol to receive the standard of care.
- interventionNames
- Drug: Radioiodine optimized therapy
Primary outcomes (1)
- measure
- Response
- timeFrame
- 6 months, repeated through study completion, an average of 2 year
- description
- Evaluation of complete response (CR) rate on soft tissue metastases 6 months after treatment, or later. The best response will be considered. RECIST 1.1 Evaluation of the best response rate on soft tissue metastases
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histo-pathological diagnosis of DTC * At least one documented non surgically-curable soft-tissue metastasis previously untreated * ECOG performance status = 0 - 1 * Life expectancy \> 6 months * Females of childbearing age must have negative serum pregnancy test prior to registration and agree to use birth control throughout the study and for 6 months after completion of therapy * Preserved hematologic and renal function (hemoglobin \> 10 g/dL; WBC \> 3500/uL; neutrophils \> 50%; PLT \> 100000/uL; albumin ≥ 2.5 g/dL; creatinine ≤ 2 mg/dL) * Signed informed consent Exclusion Criteria: * All lesions surgically resectable * Minimal lymph nodal disease (diameter \< 1 cm, up to 2 nodes) * Patient with skeletal metastases only * Lung diffuse miliary micro-metastases * Ongoing pregnancy * Breast-feeding (enrollment could be considered after suspension) * Refusal of male and female patients to use an effective contraception method during the study and for 6 months after completion of protocol therapy * Impossibility to undergo follow-up procedures * Presence of medical, psychiatric or surgical condition, not adequately controlled by treatment, which would likely affect subjects' ability to complete the protocol * Assumption of any anti-tumor therapy including chemotherapy, biological or investigational drug treatments * Assumption of any myelotoxic drugs * Previous or concomitant assumption of Amiodarone * Any other oncologic disease that required treatment in the last 5 years. * Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives prior to the study drug.
References
Publications (4)
- BACKGROUNDKlubo-Gwiezdzinska J, Van Nostrand D, Atkins F, Burman K, Jonklaas J, Mete M, Wartofsky L. Efficacy of dosimetric versus empiric prescribed activity of 131I for therapy of differentiated thyroid cancer. J Clin Endocrinol Metab. 2011 Oct;96(10):3217-25. doi: 10.1210/jc.2011-0494. Epub 2011 Aug 17. PMID 21849530
- BACKGROUNDNagarajah J, Janssen M, Hetkamp P, Jentzen W. Iodine Symporter Targeting with 124I/131I Theranostics. J Nucl Med. 2017 Sep;58(Suppl 2):34S-38S. doi: 10.2967/jnumed.116.186866. PMID 28864610
- BACKGROUNDJentzen W, Verschure F, van Zon A, van de Kolk R, Wierts R, Schmitz J, Bockisch A, Binse I. 124I PET Assessment of Response of Bone Metastases to Initial Radioiodine Treatment of Differentiated Thyroid Cancer. J Nucl Med. 2016 Oct;57(10):1499-1504. doi: 10.2967/jnumed.115.170571. Epub 2016 May 19. PMID 27199362
- BACKGROUNDJentzen W, Hoppenbrouwers J, van Leeuwen P, van der Velden D, van de Kolk R, Poeppel TD, Nagarajah J, Brandau W, Bockisch A, Rosenbaum-Krumme S. Assessment of lesion response in the initial radioiodine treatment of differentiated thyroid cancer using 124I PET imaging. J Nucl Med. 2014 Nov;55(11):1759-65. doi: 10.2967/jnumed.114.144089. Epub 2014 Oct 20. PMID 25332440