Study Stopped
Study was not initiated
An Imaging Study in Patients With Thyroid Cancer or Head and Neck Cancer With Pertechnetate Made in a Cyclotron (C-PERT)
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
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2012
CompletedFirst Posted
Study publicly available on registry
December 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedNovember 14, 2017
November 1, 2017
December 10, 2012
November 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (1)
To evaluate the safety of C-PERT from adverse event data
5 months
Study Arms (2)
C-PERT
ACTIVE COMPARATOR45 patients with cancer
G-PERT
ACTIVE COMPARATOR65 patients with cancer
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- nursing or pregnant females
- \< 18 or \> 79 Years
- uncontrolled asthma
- acute iritis
- narrow angle glaucoma
- previous radiation to head/neck
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AHS Cancer Control Albertalead
- Cross Cancer Institutecollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander McEwan, MB, FRCPC
Professor, Department of Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2012
First Posted
December 11, 2012
Primary Completion
May 1, 2013
Last Updated
November 14, 2017
Record last verified: 2017-11