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

Centre de recherche du Centre hospitalier universitaire de Sherbrooke30 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Autoimmune Thyroid Disease Congenital Hypothyroidism

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Outcomes

Primary Outcomes

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)

Time frame: 6 months

Data from ClinicalTrials.gov

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