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To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium in Patients With Thyroid Cancer

NCT ID: NCT01437254

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-01-31

Brief Summary

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The cyclotron production model of Tc-99m pertechnetate (CPERT) has received significant validation in the independent expert review conducted by Natural Resources Canada (NRCan) in the follow up to the Chalk River crisis. The University of Alberta's Edmonton PET Centre and the Edmonton Radiopharmaceutical Centre is a cyclotron / radiopharmacy unit, providing a safe, cost effective, unsubsidized, and reliable supply of radiopharmaceuticals to hospitals and clinics in Edmonton and northern Alberta. A Phase I study is proposed to show safety of CPERT as well as comparability with generator-produced Tc-99m pertechnetate (GPERT) in subjects with well differentiated thyroid carcinoma post-thyroidectomy and prior to planned I-131 Iodide treatment.

Detailed Description

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Patients who have had a thyroidectomy for cancer routinely have a Tc-99m Pertechnetate (GPERT) scan at the Cross Cancer Institute to check for thyroid tissue remnants prior to radioactive iodine therapy. The first 10 subjects will receive a CPERT whole body scan, and and 20 subsequent case-matched controls (2 for each CPERT subject, matched for age and gender) will receive a GPERT whole body scan. CPERT safety will be assessed by pre-injection and post-imaging collection of vital signs and blood samples (haematology and biochemistry). Adverse event collection will be done for both CPERT and GPERT subjects. The whole body biodistribution pattern of CPERT will be qualitatively compared to GPERT by two independent and blinded Nuclear Medicine physicians.

Conditions

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Thyroid Neoplasms

Keywords

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99mTc Pertechnetate thyroidectomy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
The Nuclear Medicine physicians interpreting the whole body biodistribution pattern of CPERT and GPERT scans were blinded.

Study Groups

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Arm Number 1 CPERT

1 CPERT scan, blood and vital sign collection

Group Type EXPERIMENTAL

CPERT

Intervention Type DRUG

Single 340 MBq CPERT scan in first 10 subjects

Arm Number 2 GPERT

1 GPERT Scan

Group Type ACTIVE_COMPARATOR

GPERT

Intervention Type DRUG

Single 340 MBq GPERT scan in up to 20 case-matched controls

Interventions

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CPERT

Single 340 MBq CPERT scan in first 10 subjects

Intervention Type DRUG

GPERT

Single 340 MBq GPERT scan in up to 20 case-matched controls

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
* Have confirmed well differentiated thyroid cancer, post-thyroidectomy and pre-RAI
* Biochemical parameters as measured are required to be within 5 times the normal limits for age
* white blood cell count (WCB) \> 3.0/µL
* absolute neutrophil count (ANC) \> 1.5/µL
* Platelets \> 75,000/µL
* Hemoglobin \> 10 g/dL
* Able and willing to follow instructions and comply with the protocol
* Provide written informed consent prior to participation in the study
* Karnofsky Performance Scale score of 50 - 100

Exclusion Criteria

* Nursing or pregnant females
* Biochemical parameters as measured outside 5 times the normal limits for age within 14 days of the pre-treatment scan
* White blood cell count (WCB \< 3.0/µL)
* absolute neutrophil count (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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Natural Resources, Canada

UNKNOWN

Sponsor Role collaborator

Edmonton PET Centre

UNKNOWN

Sponsor Role collaborator

AHS Cancer Control Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander McEwan, MB, FCRPC

Role: PRINCIPAL_INVESTIGATOR

Professor, Department of Oncology

Locations

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Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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DX-CPERT-001

Identifier Type: -

Identifier Source: org_study_id