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

November 30, 2017 updated by: Dr Éric E Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

A Phase I Study of 99m Tc Pertechnetate Produced in High Energy Cyclotron (CYCLOTEC) 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre hospitalier universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients between 18 and 80 years of age with thyroid scan indication

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

August 31, 2016

Study Completion (Actual)

October 31, 2016

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Actual)

December 4, 2017

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIMS-2014-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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