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 Sherbrooke

Status: Completed

Conditions: Autoimmune Thyroid Disease; Congenital Hypothyroidism

Study type: Observational

Funder types: Other

Identifiers

NCT02307175

CIMS-2014-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Cyclotec

Description:

The first 10 consecutively enrolled patients will have thyroid and whole body scan with CycloTec

generator produced Tc99m-pertechnetate

Description:

20 subsequent case-matched controls will have thyroid and whole body scan with conventional Tc99m-pertechnetate