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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)

Primary Purpose

Thyroid Neoplasms, Head and Neck Neoplasms

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

C-PERT

G-PERT

About this trial

This is an interventional diagnostic trial for Thyroid Neoplasms focused on measuring 99mTc Pertechnetate, thyroidectomy, thyroid neoplasms

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

C-PERT

G-PERT

Arm Description

45 patients with cancer

65 patients with cancer

Outcomes

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.

Secondary Outcome Measures

To evaluate the safety of C-PERT from adverse event data

Full Information

NCT ID

NCT01747512

First Posted

December 10, 2012

Last Updated

November 10, 2017

Sponsor

AHS Cancer Control Alberta

Collaborators

Cross Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT01747512

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Study was not initiated

Study Start Date

undefined (undefined)

Primary Completion Date

May 2013 (Anticipated)

Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

Collaborators

Cross Cancer Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid Neoplasms, Head and Neck Neoplasms

Keywords

99mTc Pertechnetate, thyroidectomy, thyroid neoplasms

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

C-PERT

Arm Type

Active Comparator

Arm Description

45 patients with cancer

Arm Title

G-PERT

Arm Type

Active Comparator

Arm Description

65 patients with cancer

Intervention Type

Drug

Intervention Name(s)

C-PERT

Intervention Description

Patients with thyroid and Head and Neck cancer

Intervention Type

Drug

Intervention Name(s)

G-PERT

Intervention Description

Patients with thyroid and Head and Neck cancer

Primary Outcome Measure Information:

Title

Time Frame

5 months

Secondary Outcome Measure Information:

Title

To evaluate the safety of C-PERT from adverse event data

Time Frame

5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander McEwan, MB, FRCPC

Organizational Affiliation

Professor, Department of Oncology

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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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