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

NCT02307175 | Completed

• 1 other identifier: CIMS-2014-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Thyroid Disease; Congenital Hypothyroidism

Outcome Measures

Primary Outcomes (1)

• Biodistribution of Tc99m produced by high-energy cyclotron (CycloTec)

  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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: lead

Study Sites (1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Congenital Hypothyroidism

Condition Hierarchy (Ancestors)

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

Study Officials

• Eric Turcotte, MD

  Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Nuclear medicine specialist, Head of Clinical Research at CIMS

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: December 4, 2014
• Study Start: September 1, 2014
• Primary Completion: August 31, 2016
• Study Completion: October 31, 2016
• Last Updated: December 4, 2017

Record last verified: 2017-11

Locations

CA (1)