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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by AHS Cancer Control Alberta.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT01747512
First received: December 10, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 115
Study Start Date: January 2013
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (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

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747512

Locations
Canada, Alberta
Cross Cancer Institute Not yet 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

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01747512     History of Changes
Other Study ID Numbers: DX-CPERT-002
Study First Received: December 10, 2012
Last Updated: December 10, 2012
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on October 23, 2014