A Study of 99m Tc Pertechnetate Produced in High Energy C... | NCT02307175

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

NCT02307175

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Status

Completed

Last Update Posted

Dec 4, 2017Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Autoimmune Thyroid Disease
Congenital Hypothyroidism

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2014Actual

Primary Completion Date

Aug 31, 2016Actual

Completion Date

Oct 31, 2016Actual

First Submitted Date

Sep 24, 2014

First Submission Date that Met QC Criteria

Dec 1, 2014

First Posted Date

Dec 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2017

Last Update Posted Date

Dec 4, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Éric E Turcotte, MD, MD, Nuclear medicine specialist, Head of Clinical Research at CIMS, Centre de recherche du Centre hospitalier universitaire de SherbrookePrincipal Investigator

Lead Sponsor

Centre de recherche du Centre hospitalier universitaire de SherbrookeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Turcotte, MD	Centre de recherche du Centre hospitalier universitaire de Sherbrooke	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre hospitalier universitaire de Sherbrooke		Sherbrooke	Quebec	J1H 5N4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D003409	Congenital Hypothyroidism

Ancestor Terms

ID	Term
D004392	Dwarfism
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided