Congenital Hypothyroidism Clinical Trial
Official title:
A Phase I Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron (CYCLOTEC) in Patients With Thyroid Scan Indication
Verified date | November 2017 |
Source | Centre de recherche du Centre hospitalier universitaire de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Prospective, open label single site study to demonstrate the safety and efficacy of Tc-99m pertechnetate produced by high energy cyclotron at CHUS.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 31, 2016 |
Est. primary completion date | August 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre de recherche du Centre hospitalier universitaire de Sherbrooke |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biodistribution of Tc99m produced by high-energy cyclotron (CycloTec) | 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) | 6 months |
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