Clinical trial · Observational
Investigating National Solutions for Personalised Iodine-131 Radiation Exposure
Investigating National Solutions for Personalised Iodine-131 Radiation Exposure - Measuring Absorbed Dose to Tumour and Organs at Risk Following Routine Iodine Ablation Therapy
NCT04391244CI-TRIAL-00068902INSPIREunknownClinicalTrials.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)
This is a single-arm non-interventional prospective observational study to perform quantitative I-131 imaging and patient-specific dosimetry for patients undergoing radioiodine treatment.
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 |
|---|---|---|---|
| Differentiated Thyroid Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Range of absorbed doses and associated uncertainties delivered to thyroid remnants, residual disease, metastatic disease and healthy organs.
- timeFrame
- 9 months
- description
- To establish the range of absorbed doses and associated uncertainties delivered to thyroid remnants, residual disease, metastatic disease and healthy organs from an administration of I-131 radioiodine.
Secondary outcomes (4)
- measure
- Proportion of patients with successful treatment.
- timeFrame
- 9 months
- description
- Investigation into the relationship between quantitative uptake values and/or absorbed doses delivered and treatment success. Treatment success will be defined by a thyroglobulin level of less than 2.0 ng per millilitre at 6-9 months post treatment.
- measure
- Threshold absorbed dose to the thyroid remnant for treatment success.
- timeFrame
- 9 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Histologically proven DTC (pT1b - pT3, any N, any M) * Total thyroidectomy performed * WHO PS 0-2 (autonomous, self-caring) Exclusion Criteria: * External radiotherapy in the last 6 weeks * Systematic chemotherapy in the last 6 weeks * Pregnancy or breast feeding
References
Publications (1)
- DERIVEDTaprogge J, Abreu C, Vavrova L, Carnegie-Peake L, Rushforth D, Gape P, Gear J, Murray I, Wong KH, Newbold K, Yusuf S, Flux G. Initial results of the INSPIRE clinical trial-investigating radiation dosimetry for differentiated thyroid cancer patients. Front Nucl Med. 2023 May 15;3:964478. doi: 10.3389/fnume.2023.964478. eCollection 2023. PMID 39380954