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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)

This study is currently recruiting participants.
Verified March 2016 by AHS Cancer Control Alberta
Sponsor:
ClinicalTrials.gov Identifier:
NCT01747512
First Posted: December 11, 2012
Last Update Posted: March 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta
  Purpose
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.

Condition Intervention Phase
Thyroid Neoplasms Head and Neck Neoplasms Drug: C-PERT Drug: G-PERT Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To evaluate the safety of C-PERT from adverse event data [ Time Frame: 5 months ]

Estimated Enrollment: 115
Study Start Date: January 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: G-PERT
Patients with thyroid and Head and Neck cancer

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Marg Landon    780 432-8751      
Contact: Merlita Lamadrid    780 432-8751      
Principal Investigator: AJB McEwan, MB         
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
Investigators
Principal Investigator: AJB McEwan, MB Department of Oncology, Cross Cancer Institute, Cancer Care, Alberta Health Services
  More Information

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01747512     History of Changes
Other Study ID Numbers: DX-CPERT-002
First Submitted: December 10, 2012
First Posted: December 11, 2012
Last Update Posted: March 11, 2016
Last Verified: March 2016

Keywords provided by AHS Cancer Control Alberta:
99mTc Pertechnetate
thyroidectomy
thyroid neoplasms

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Thyroid Diseases
Thyroid Neoplasms
Neoplasms by Site
Endocrine System Diseases
Endocrine Gland Neoplasms
Sodium Pertechnetate Tc 99m
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action