An Imaging Study in Patients With Thyroid Cancer or Head... | NCT01747512

Studies
An Imaging Study in Patients With Thyroid Cancer or Head and Neck Cancer With Pertechnetate Made in a Cyclotron (C-PERT)

NCT01747512

Sponsor

AHS Cancer Control Alberta

Status

Withdrawn

Last Update Posted

Nov 14, 2017Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Thyroid Neoplasms
Head and Neck Neoplasms

Interventions

C-PERT
G-PERT

Countries

Not provided

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

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was not initiated

Expanded Access Info

Start Date

Not provided

Primary Completion Date

May 2013Estimated

Completion Date

Not provided

First Submitted Date

Dec 10, 2012

First Submission Date that Met QC Criteria

Dec 10, 2012

First Posted Date

Dec 11, 2012Estimated

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 10, 2017

Last Update Posted Date

Nov 14, 2017Actual

Name	Class
Cross Cancer Institute	OTHER

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

Doctors at the Cross Cancer Institute have developed a new method of producing 99mTc Pertechnetate in a cyclotron unit. A study done at the Cross Cancer Institute in 2011 with ten patients using this imaging agent showed that it was safe and produced images with the same pattern as generator produced Pertechnetate. This study is now being done in larger numbers of patients to again show that the imaging pattern of both agents is the same, and to again demonstrate its safety.

Detailed Description

To demonstrate the efficacy of cyclotron-produced Tc-99m pertechnetate (C-PERT; manufactured by the Edmonton PET Centre/ERC) in comparison to generator-produced Tc-99m pertechnetate (G-PERT; from approved commercial source; using qualitative and quantitative clinical imaging biodistribution data.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
C-PERT	Active Comparator	45 patients with cancer	Drug: C-PERT
G-PERT	Active Comparator	65 patients with cancer	Drug: G-PERT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
C-PERT	Drug	Patients with thyroid and Head and Neck cancer	C-PERT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To demonstrate the efficacy of C-PERT (manufactured by the Edmonton PET Centre/ERC) in comparison to G-PERT (fromm approved commercial sources) using qualitative and quantitative clinical imaging biodistribtion data.		5 months

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the safety of C-PERT from adverse event data		5 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

thyroid cancer, or
Head and Neck cancer for salivary gland transfer
age 18-79
biochemical parameters < 5x ULN
WBC > 3.0/uL
ANC > 1.5/uL
platelets > 75,000/uL
hemoglobin > 10 g/dL
Karnofsky 50-100

Exclusion Criteria:

nursing or pregnant females
< 18 or > 79 Years
uncontrolled asthma
acute iritis
narrow angle glaucoma
previous radiation to head/neck

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexander McEwan, MB, FRCPC	Professor, Department of Oncology	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013964	Thyroid Neoplasms
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided