An Imaging Study in Patients With Thyroid Cancer or Head and Neck Cancer With Pertechnetate Made in a Cyclotron (C-PERT)
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ClinicalTrials.gov Identifier: NCT01747512 |
Recruitment Status :
Withdrawn
(Study was not initiated)
First Posted : December 11, 2012
Last Update Posted : November 14, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Thyroid Neoplasms Head and Neck Neoplasms | Drug: C-PERT Drug: G-PERT | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | 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 |
Estimated Primary Completion Date : | May 2013 |
Arm | Intervention/treatment |
---|---|
Active Comparator: C-PERT
45 patients with cancer
|
Drug: C-PERT
Patients with thyroid and Head and Neck cancer |
Active Comparator: G-PERT
65 patients with cancer
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Drug: G-PERT
Patients with thyroid and Head and Neck cancer |
- 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. [ Time Frame: 5 months ]
- To evaluate the safety of C-PERT from adverse event data [ Time Frame: 5 months ]

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Ages Eligible for Study: | 18 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747512
Principal Investigator: | Alexander McEwan, MB, FRCPC | Professor, Department of Oncology |
Responsible Party: | AHS Cancer Control Alberta |
ClinicalTrials.gov Identifier: | NCT01747512 |
Other Study ID Numbers: |
DX-CPERT-002 |
First Posted: | December 11, 2012 Key Record Dates |
Last Update Posted: | November 14, 2017 |
Last Verified: | November 2017 |
99mTc Pertechnetate thyroidectomy thyroid neoplasms |
Neoplasms Head and Neck Neoplasms Thyroid Neoplasms Thyroid Diseases |
Neoplasms by Site Endocrine System Diseases Endocrine Gland Neoplasms |