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

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

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Key information

Conditions

Autoimmune Thyroid Disease Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Congenital Hypothyroidism Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Endocrine System Diseases Genetic Diseases, Inborn Hypothyroidism Musculoskeletal Diseases Thyroid Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Other

Registry information

Official study title

A Phase I Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron (CYCLOTEC) in Patients With Thyroid Scan Indication

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Dec 4, 2014
Registry last updated: Dec 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed