Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03986437
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 25 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.
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Iodine




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986437


Contacts
Layout table for location contacts
Contact: Frédéric COURBON +33 5 31 15 55 26 Courbon.frederic@iuct-oncopole.fr

Locations
Layout table for location information
France
IUCT-O Not yet recruiting
Toulouse, France
Contact: Frédéric COURBON    +33 5 31 15 55 26    Courbon.frederic@iuct-oncopole.fr   
Sponsors and Collaborators
Institut Claudius Regaud

Layout table for additonal information
Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT03986437     History of Changes
Other Study ID Numbers: 19VADS05
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Claudius Regaud:
Differentiated Thyroid Cancer
Iodine-131
Thyroidectomy

Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs