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出境医 / 临床实验 / A Prospective Study to Collect Images in Patients Treated With Iodine-131 as Part of a European Research Project in Radiation Protection. (MEDIRAD)

A Prospective Study to Collect Images in Patients Treated With Iodine-131 as Part of a European Research Project in Radiation Protection. (MEDIRAD)

Study Description
Brief Summary:

This trial is a prospective, non-interventional, monocentric study aiming to collect standard of care imaging of patients treated with Iodine-131 for the determination of dosimetric studies.

Data from this study will be collected as part of an European research project called MEDIRAD.

The overall objectives of this project are to enhance the scientific bases and clinical practice of radiation protection in the medical field, and more specifically to develop and implement the tools necessary to establish the range of absorbed doses delivered to healthy organs in patients undergoing thyroid ablation and the threshold absorbed dose required for thyroid ablation. This will enable patient specific treatment planning that will minimize risk to the patient while ensuring a successful outcome and will facilitate development of a large scale epidemiological study of the effect of low absorbed doses from irradiation of normal organs with internal sources of radionuclides.

Patients will be followed as part of their standard of care. Imaging (SPECT/CT (Single Photon Emission Computed Tomography-Computerized Tomography) and Whole Body scintigraphy) performed at 48 hours post Iodine-131 treatment will be collected. Measures of external gamma radiation will also be collected in the European database.


Condition or disease
Differentiated Thyroid Cancer

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study to Collect Images in Patients Treated With Iodine-131 as Part of a European Research Project in Radiation Protection.
Actual Study Start Date : January 13, 2020
Actual Primary Completion Date : May 21, 2021
Actual Study Completion Date : May 21, 2021
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Number of patients with interpretable images [ Time Frame: 1 week per patient ]

Secondary Outcome Measures :
  1. Rate of radiation dose [ Time Frame: 1 week per patient ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with differentiated thyroid cancer and who are eligible for a Iodine-131 (I-131) treatment after a total thyroidectomy or completion thyroidectomy will be invited to join the study.
Criteria

Inclusion Criteria:

  1. Patient with differentiated thyroid cancer (papillary or follicular) stage T1b, T2, T3A, Nx-N0-N1, M0 (according to AJCC 8th edition, 2017) of intermediate risk of recurrence (according to 2015 ATA Risk Stratification System)
  2. Patient is eligible to receive a therapeutic activity of 3.7 GBq of I-131 after total thyroidectomy or completion thyroidectomy
  3. Age ≥ 18 years old
  4. Patient affiliated to the French social security system
  5. Patient who has received an informed consent for the study

Exclusion Criteria:

  1. Patient who has received an external radiotherapy within 6 weeks prior to I-131 treatment
  2. Patient who has received a systemic chemotherapy within 6 weeks prior to I-131 treatment
  3. History of treatment with I-131
  4. Pregnant or breastfeeding women
  5. Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures
  6. Patient protected by law
Contacts and Locations

Locations
Layout table for location information
France
IUCT-O
Toulouse, France
Sponsors and Collaborators
Institut Claudius Regaud
Tracking Information
First Submitted Date June 11, 2019
First Posted Date June 14, 2019
Last Update Posted Date May 27, 2021
Actual Study Start Date January 13, 2020
Actual Primary Completion Date May 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2019) 		Number of patients with interpretable images [ Time Frame: 1 week per patient ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 13, 2019) 		Rate of radiation dose [ Time Frame: 1 week per patient ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Prospective Study to Collect Images in Patients Treated With Iodine-131 as Part of a European Research Project in Radiation Protection.
Official Title A Prospective Study to Collect Images in Patients Treated With Iodine-131 as Part of a European Research Project in Radiation Protection.
Brief Summary

This trial is a prospective, non-interventional, monocentric study aiming to collect standard of care imaging of patients treated with Iodine-131 for the determination of dosimetric studies.

Data from this study will be collected as part of an European research project called MEDIRAD.

The overall objectives of this project are to enhance the scientific bases and clinical practice of radiation protection in the medical field, and more specifically to develop and implement the tools necessary to establish the range of absorbed doses delivered to healthy organs in patients undergoing thyroid ablation and the threshold absorbed dose required for thyroid ablation. This will enable patient specific treatment planning that will minimize risk to the patient while ensuring a successful outcome and will facilitate development of a large scale epidemiological study of the effect of low absorbed doses from irradiation of normal organs with internal sources of radionuclides.

Patients will be followed as part of their standard of care. Imaging (SPECT/CT (Single Photon Emission Computed Tomography-Computerized Tomography) and Whole Body scintigraphy) performed at 48 hours post Iodine-131 treatment will be collected. Measures of external gamma radiation will also be collected in the European database.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All patients with differentiated thyroid cancer and who are eligible for a Iodine-131 (I-131) treatment after a total thyroidectomy or completion thyroidectomy will be invited to join the study.
Condition Differentiated Thyroid Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 25, 2021) 		29
Original Estimated Enrollment
 (submitted: June 13, 2019) 		25
Actual Study Completion Date May 21, 2021
Actual Primary Completion Date May 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patient with differentiated thyroid cancer (papillary or follicular) stage T1b, T2, T3A, Nx-N0-N1, M0 (according to AJCC 8th edition, 2017) of intermediate risk of recurrence (according to 2015 ATA Risk Stratification System)
  2. Patient is eligible to receive a therapeutic activity of 3.7 GBq of I-131 after total thyroidectomy or completion thyroidectomy
  3. Age ≥ 18 years old
  4. Patient affiliated to the French social security system
  5. Patient who has received an informed consent for the study

Exclusion Criteria:

  1. Patient who has received an external radiotherapy within 6 weeks prior to I-131 treatment
  2. Patient who has received a systemic chemotherapy within 6 weeks prior to I-131 treatment
  3. History of treatment with I-131
  4. Pregnant or breastfeeding women
  5. Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures
  6. Patient protected by law
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03986437
Other Study ID Numbers 19VADS05
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Institut Claudius Regaud
Study Sponsor Institut Claudius Regaud
Collaborators Not Provided
Investigators Not Provided
PRS Account Institut Claudius Regaud
Verification Date May 2020

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