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A Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron in Patients With Thyroid Scan Indication

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ClinicalTrials.gov Identifier: NCT02307175
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Éric E Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Brief Summary:
Prospective, open label single site study to demonstrate the safety and efficacy of Tc-99m pertechnetate produced by high energy cyclotron at CHUS.

Condition or disease
Autoimmune Thyroid Disease Congenital Hypothyroidism

Detailed Description:
The proposed clinical trial will be a prospective, case-controlled Phase I, open label, single site study. The first 10 consecutively enrolled patients will receive CYCLOTEC standard procedure thyroid imagery and an additional whole-body scans, and 20 subsequent case-matched controls, will receive GPERT and will also have additionnal whole body scan.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Phase I Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron (CYCLOTEC) in Patients With Thyroid Scan Indication
Actual Study Start Date : September 1, 2014
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : October 31, 2016


Group/Cohort
Cyclotec
The first 10 consecutively enrolled patients will have thyroid and whole body scan with CycloTec
generator produced Tc99m-pertechnetate
20 subsequent case-matched controls will have thyroid and whole body scan with conventional Tc99m-pertechnetate



Primary Outcome Measures :
  1. Biodistribution of Tc99m produced by high-energy cyclotron (CycloTec) [ Time Frame: 6 months ]
    Equivalence of biodistribution of Tc99m produced by high-energy cyclotron (CycloTec) will be compared to the biodistribution of the conventional Tc99m pertechnetated (Case match: 1 CycloTec patient vs. 2 conventional Tc99m-pertechnetate patients)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients between 18 and 80 years of age with thyroid scan indication
Criteria

Inclusion Criteria:

  • Prescribed thyroid scan
  • Provided written informed consent prior to participation
  • Biochemical parameters within 5 times of the normal limits for age
  • WBC count > 3.0/μL
  • ANC count 1.5/μL
  • Platelets > 75,000/μL
  • Haemoglobin > 10 g/dL
  • Karnofsky Performance Scale score > 50

Exclusion Criteria:

  • Nursing or pregnant females
  • Biochemical parameters as measured outside 5 times the normal limits for age within 14 days of the scan
  • WBC < 3.0/μL
  • ANC < 1.5/μL
  • Platelets < 75,000/μL
  • Haemoglobin < 10 g/dL
  • Unable and unwilling to follow instructions and comply with the protocol
  • Unable or unwilling to provide written informed consent prior to participation in the study
  • Karnofsky Performance Scale score < 50

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): NCT02307175


Locations
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Canada, Quebec
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Investigators
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Principal Investigator: Eric Turcotte, MD Centre de recherche du Centre hospitalier universitaire de Sherbrooke
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Responsible Party: Dr Éric E Turcotte, MD, MD, Nuclear medicine specialist, Head of Clinical Research at CIMS, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT02307175    
Other Study ID Numbers: CIMS-2014-01
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Congenital Hypothyroidism
Thyroid Diseases
Hypothyroidism
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Genetic Diseases, Inborn