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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-01

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Autoimmune Thyroid Disease Congenital Hypothyroidism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cyclotec

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

No interventions assigned to this group

generator produced Tc99m-pertechnetate

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Dr Éric E Turcotte, MD

MD, Nuclear medicine specialist, Head of Clinical Research at CIMS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Turcotte, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Locations

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Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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CIMS-2014-01

Identifier Type: -

Identifier Source: org_study_id