- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04391244
Investigating National Solutions for Personalised Iodine-131 Radiation Exposure (INSPIRE)
Investigating National Solutions for Personalised Iodine-131 Radiation Exposure - Measuring Absorbed Dose to Tumour and Organs at Risk Following Routine Iodine Ablation Therapy
Study Overview
Status
Conditions
Detailed Description
The hypothesis underlying this study is that treatment outcome in molecular radiotherapy is dependent on the absorbed doses delivered rather than on the radioactivity administered. For up to 50 patients, post treatment dosimetry will be performed to establish the range of absorbed doses and associated uncertainties delivered to thyroid remnants, residual disease, and healthy organs from an ablative administration of I-131 radioiodine.
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yvonne Fox-Miller
- Phone Number: 020 86613760
- Email: yvonne.fox-miller@rmh.nhs.uk
Study Contact Backup
- Name: Jan Taprogge
- Phone Number: 020 8661 3086
- Email: jan.taprogge@icr.ac.uk
Study Locations
-
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Surrey
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Sutton, Surrey, United Kingdom, SM2 5PT
- Recruiting
- The Royal Marsden NHS Foundation Trust
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Contact:
- Jan Taprogge
- Phone Number: 020 8661 3086
- Email: jan.taprogge@icr.ac.uk
-
Contact:
- Yvonne Fox-Miller
- Phone Number: 020 8661 3760
- Email: yvonne.fox-miller@rmh.nhs.uk
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Principal Investigator:
- Glenn Flux
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of absorbed doses and associated uncertainties delivered to thyroid remnants, residual disease, metastatic disease and healthy organs.
Time Frame: 9 months
|
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.
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with successful treatment.
Time Frame: 9 months
|
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.
|
9 months
|
Threshold absorbed dose to the thyroid remnant for treatment success.
Time Frame: 9 months
|
To establish a threshold absorbed dose to the thyroid remnant required for treatment success.
The association between these absorbed doses and the therapy outcome will be investigated, using logistic regression modelling as appropriate, with absorbed dose as a continuous variable.
The relationship between the absorbed doses delivered and treatment success will be analysed using ROC analysis to establish a threshold absorbed dose for treatment success.
|
9 months
|
Association of biomarkers with absorbed dose
Time Frame: 9 months
|
The association between absorbed doses and biomarkers (routine clinical haematological and biochemistry measurements) will be investigated using univariate logistic regression modelling as appropriate, with haematological and biochemistry measurements as continuous variables.
|
9 months
|
Association of biomarkers with treatment success
Time Frame: 9 months
|
The association between treatment success and biomarkers (routine clinical haematological and biochemistry measurements) will be investigated using univariate logistic regression modelling as appropriate with haematological and biochemistry measurements as continuous variables.
Treatment success will be defined by a thyroglobulin level of less than 2.0 ng per millilitre at 6-9 months post treatment.
|
9 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Kate Newbold, Consultant Clinical Oncologist
- Principal Investigator: Glenn Flux, Head of Radioisotope Physics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCR5109
- 20/EM/0022 (Other Identifier: REC No)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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