Investigating National Solutions for Personalised Iodine-131 Radiation Exposure (INSPIRE)

August 16, 2023 updated by: Royal Marsden NHS Foundation Trust

Investigating National Solutions for Personalised Iodine-131 Radiation Exposure - Measuring Absorbed Dose to Tumour and Organs at Risk Following Routine Iodine Ablation Therapy

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.

Study Overview

Status

Recruiting

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

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Differentiated Thyroid Cancer

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Chair: Kate Newbold, Consultant Clinical Oncologist
  • Principal Investigator: Glenn Flux, Head of Radioisotope Physics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2020

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Differentiated Thyroid Cancer

3
Subscribe