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

November 10, 2017 updated by: AHS Cancer Control Alberta

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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
Drug: G-PERT
Patients with thyroid and Head and Neck cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 5 months
5 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Collaborators

Cross Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (ANTICIPATED)

May 1, 2013

Study Registration Dates

First Submitted

December 10, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (ESTIMATE)

December 11, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DX-CPERT-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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