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

Completed

• Conditions: Autoimmune Thyroid Disease; Congenital Hypothyroidism

• Registration Number: NCT02307175
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-09-01
• Study First Submitted: 2014-09-24
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-04
• Primary Completion: 2016-08-31
• Study Completion: 2016-10-31
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-30
• Last Update Posted: 2017-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biodistribution of Tc99m produced by high-energy cyclotron (CycloTec)	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)

Trial Locations

Locations (1)

Centre hospitalier universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada