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

Congenital Hypothyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307175
• Other study ID #: CIMS-2014-01
• Status: Completed
• Phase: N/A
• First received: September 24, 2014
• Last updated: November 30, 2017
• Start date: September 1, 2014
• Est. completion date: October 31, 2016

Study information

• Verified date: November 2017
• Source: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Thyroid Disease
• Congenital Hypothyroidism
• Hypothyroidism
• Thyroid Diseases

Locations

Country	Name	City	State
Canada	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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