Investigating National Solutions for Personalised Iodine-131 Radiation Exposure
NCT ID: NCT04391244
Last Updated: 2023-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2020-06-17
2025-03-31
Brief Summary
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Detailed Description
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Imaging systems in participating centres will be characterised (system volume sensitivity, partial-volume effect and dead-time) and set up for quantitative imaging to allow for collation of data. Patients will be assigned to one of two dosimetry gamma camera scanning schedules. For scanning schedule 1 (Standard of Care) a single standard-of-care scan (SPECT/CT) will be acquired according to local protocol with regards to time post-radioiodine administration. A minimum of 20 patients will be assigned to scanning schedule 2 (Standard of Care + Additional Imaging), for which a standard-of-care scan and two to four additional SPECT scans will be acquired between 6 - 168 hours post-administration.
SPECT imaging datasets will be reconstructed with attenuation and scatter corrections to allow quantitative dosimetry calculations. Time integrated activity will be derived from analysis of the quantitative SPECT data and combined with relevant dose factors to obtain absorbed dose estimates for each target tissue. The subset of patients with additional imaging will be used to establish the pharmacokinetic properties of radioiodine in each tissue type (biological retention half-life) to enable determination of time integrated activity in patients with a single standard-of-care scan.
A minimum of 3 whole-body retention measurements will be performed per day during the patient's stay in hospital, approximately every 2-6 hours, according to local standard of care procedures. At each external measurement time point the quantified level of radioactivity in the whole body will be recorded.
Patients will be followed-up at their standard-of-care clinic visits to assess the success of treatment as well as for short to mid-term toxicity. Results from standard of care biochemical, radiological and haematological assessments (TSH, thyroglobulin, anti-thyroglobulin antibodies, ultrasound, serum creatinine, haemoglobin, white cell count, neutrophil count and platelet count) will be recorded to assess response to treatment. Statistical analysis of the relationship between the absorbed doses and outcome data will be performed.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Histologically proven DTC (pT1b - pT3, any N, any M)
* Total thyroidectomy performed
* WHO PS 0-2 (autonomous, self-caring)
Exclusion Criteria
* Systematic chemotherapy in the last 6 weeks
* Pregnancy or breast feeding
18 Years
ALL
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Kate Newbold
Role: STUDY_CHAIR
Consultant Clinical Oncologist
Glenn Flux
Role: PRINCIPAL_INVESTIGATOR
Head of Radioisotope Physics
Locations
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The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Taprogge 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.
Other Identifiers
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20/EM/0022
Identifier Type: OTHER
Identifier Source: secondary_id
CCR5109
Identifier Type: -
Identifier Source: org_study_id
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