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

Study Overview
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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.

Official Title
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A Phase II/III Study of Cyclotron-produced Tc-99m Pertechnetate (C-PERT) Efficacy and Safety in Patients With Conformed and Suspected Thyroid Cancer or Head and Neck Cancer

Conditions
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Thyroid Neoplasms, Head and Neck Neoplasms

Intervention / Treatment
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* Drug: C-PERT
* Drug: G-PERT


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: C-PERT<br>45 patients with cancer | Drug: C-PERT<br>* Patients with thyroid and Head and Neck cancer<br>|
| Active Comparator: G-PERT<br>65 patients with cancer | Drug: G-PERT<br>* Patients with thyroid and Head and Neck cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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99mTc Pertechnetate, thyroidectomy, thyroid neoplasms