Status:
COMPLETED
A Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron in Patients With Thyroid Scan Indication
Lead Sponsor:
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Conditions:
Autoimmune Thyroid Disease
Congenital Hypothyroidism
Eligibility:
All Genders
18-80 years
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.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02307175
Start Date
September 1 2014
End Date
October 31 2016
Last Update
December 4 2017
Active Locations (1)
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1
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4