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

NCT ID: NCT01747512

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

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Thyroid Neoplasms Head and Neck Neoplasms

Keywords

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99mTc Pertechnetate thyroidectomy thyroid neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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C-PERT

45 patients with cancer

Group Type ACTIVE_COMPARATOR

C-PERT

Intervention Type DRUG

Patients with thyroid and Head and Neck cancer

G-PERT

65 patients with cancer

Group Type ACTIVE_COMPARATOR

G-PERT

Intervention Type DRUG

Patients with thyroid and Head and Neck cancer

Interventions

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C-PERT

Patients with thyroid and Head and Neck cancer

Intervention Type DRUG

G-PERT

Patients with thyroid and Head and Neck cancer

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cross Cancer Institute

OTHER

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, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Professor, Department of Oncology

Countries

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Canada

Other Identifiers

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DX-CPERT-002

Identifier Type: -

Identifier Source: org_study_id