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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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.

Detailed Summary: 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.
Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Dates:
Date Received: September 24, 2014
Date Started: September 2014
Date Completion: December 2016
Last Updated: April 5, 2016
Last Verified: April 2016