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

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke (Other)

Overall Status

Completed

CT.gov ID

NCT02307175

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Thyroid Disease Congenital Hypothyroidism

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 Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Aug 31, 2016

Actual Study Completion Date :

Oct 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Cyclotec The first 10 consecutively enrolled patients will have thyroid and whole body scan with CycloTec
generator produced Tc99m-pertechnetate 20 subsequent case-matched controls will have thyroid and whole body scan with conventional Tc99m-pertechnetate

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec	Canada	J1H 5N4

Sponsors and Collaborators

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Investigators

Principal Investigator: Eric Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Éric E Turcotte, MD, MD, Nuclear medicine specialist, Head of Clinical Research at CIMS, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

ClinicalTrials.gov Identifier:

NCT02307175

Other Study ID Numbers:

CIMS-2014-01

First Posted:

Dec 4, 2014

Last Update Posted:

Dec 4, 2017

Last Verified:

Nov 1, 2017

Additional relevant MeSH terms:

Congenital Hypothyroidism

Thyroid Diseases

Hypothyroidism

Study Results

No Results Posted as of Dec 4, 2017