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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02307175

Enrollment

Registered

2014-12-04

Start date

2014-09-01

Completion date

2016-10-31

Last updated

2017-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Thyroid Disease, Congenital Hypothyroidism

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 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

Canada

Outcome results