search
Back to results

To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium in Patients With Thyroid Cancer

Primary Purpose

Thyroid Neoplasms

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
CPERT
GPERT
Sponsored by
AHS Cancer Control Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
  • Have confirmed well differentiated thyroid cancer, post-thyroidectomy and pre-RAI
  • Biochemical parameters as measured are required to be within 5 times the normal limits for age
  • white blood cell count (WCB) > 3.0/µL
  • absolute neutrophil count (ANC) > 1.5/µL
  • Platelets > 75,000/µL
  • Hemoglobin > 10 g/dL
  • Able and willing to follow instructions and comply with the protocol
  • Provide written informed consent prior to participation in the study
  • Karnofsky Performance Scale score of 50 - 100

Exclusion Criteria:

  • Nursing or pregnant females
  • Biochemical parameters as measured outside 5 times the normal limits for age within 14 days of the pre-treatment scan
  • White blood cell count (WCB < 3.0/µL)
  • absolute neutrophil count (ANC) < 1.5/µL
  • Platelets < 75,000/µL
  • Haemoglobin < 10 g/dL
  • unable and unwilling to follow instructions and comply with the protocol
  • unable or unwilling to provide written informed consent prior to participation in the study
  • Karnofsky Performance Scale score <50

Sites / Locations

  • Cross Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Number 1 CPERT

Arm Number 2 GPERT

Arm Description

1 CPERT scan, blood and vital sign collection

1 GPERT Scan

Outcomes

Primary Outcome Measures

Safety of CPERT
CPERT safety will be assessed by evaluation of vital signs (pre-injection and post-imaging), blood haematology (pre-injection and post-imaging), SMA-12 clinical biochemistry profile (pre-injection and post-imaging) and collection of adverse events.

Secondary Outcome Measures

Comparison of general biodistribution of CPERT and GPERT.
The whole body biodistribution pattern of CPERT will be compared to GPERT using two independent and blinded Nuclear Medicine physicians.

Full Information

First Posted
September 19, 2011
Last Updated
November 10, 2017
Sponsor
AHS Cancer Control Alberta
Collaborators
Natural Resources, Canada, Edmonton PET Centre
search

1. Study Identification

Unique Protocol Identification Number
NCT01437254
Brief Title
To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium in Patients With Thyroid Cancer
Official Title
A Phase I Study of Cyclotron-produced Tc-99m Pertechnetate (CPERT) in Patients With Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (Actual)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
Collaborators
Natural Resources, Canada, Edmonton PET Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The cyclotron production model of Tc-99m pertechnetate (CPERT) has received significant validation in the independent expert review conducted by Natural Resources Canada (NRCan) in the follow up to the Chalk River crisis. The University of Alberta's Edmonton PET Centre and the Edmonton Radiopharmaceutical Centre is a cyclotron / radiopharmacy unit, providing a safe, cost effective, unsubsidized, and reliable supply of radiopharmaceuticals to hospitals and clinics in Edmonton and northern Alberta. A Phase I study is proposed to show safety of CPERT as well as comparability with generator-produced Tc-99m pertechnetate (GPERT) in subjects with well differentiated thyroid carcinoma post-thyroidectomy and prior to planned I-131 Iodide treatment.
Detailed Description
Patients who have had a thyroidectomy for cancer routinely have a Tc-99m Pertechnetate (GPERT) scan at the Cross Cancer Institute to check for thyroid tissue remnants prior to radioactive iodine therapy. The first 10 subjects will receive a CPERT whole body scan, and and 20 subsequent case-matched controls (2 for each CPERT subject, matched for age and gender) will receive a GPERT whole body scan. CPERT safety will be assessed by pre-injection and post-imaging collection of vital signs and blood samples (haematology and biochemistry). Adverse event collection will be done for both CPERT and GPERT subjects. The whole body biodistribution pattern of CPERT will be qualitatively compared to GPERT by two independent and blinded Nuclear Medicine physicians.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasms
Keywords
99mTc Pertechnetate, thyroidectomy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The Nuclear Medicine physicians interpreting the whole body biodistribution pattern of CPERT and GPERT scans were blinded.
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm Number 1 CPERT
Arm Type
Experimental
Arm Description
1 CPERT scan, blood and vital sign collection
Arm Title
Arm Number 2 GPERT
Arm Type
Active Comparator
Arm Description
1 GPERT Scan
Intervention Type
Drug
Intervention Name(s)
CPERT
Intervention Description
Single 340 MBq CPERT scan in first 10 subjects
Intervention Type
Drug
Intervention Name(s)
GPERT
Intervention Description
Single 340 MBq GPERT scan in up to 20 case-matched controls
Primary Outcome Measure Information:
Title
Safety of CPERT
Description
CPERT safety will be assessed by evaluation of vital signs (pre-injection and post-imaging), blood haematology (pre-injection and post-imaging), SMA-12 clinical biochemistry profile (pre-injection and post-imaging) and collection of adverse events.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Comparison of general biodistribution of CPERT and GPERT.
Description
The whole body biodistribution pattern of CPERT will be compared to GPERT using two independent and blinded Nuclear Medicine physicians.
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required. Have confirmed well differentiated thyroid cancer, post-thyroidectomy and pre-RAI Biochemical parameters as measured are required to be within 5 times the normal limits for age white blood cell count (WCB) > 3.0/µL absolute neutrophil count (ANC) > 1.5/µL Platelets > 75,000/µL Hemoglobin > 10 g/dL Able and willing to follow instructions and comply with the protocol Provide written informed consent prior to participation in the study Karnofsky Performance Scale score of 50 - 100 Exclusion Criteria: Nursing or pregnant females Biochemical parameters as measured outside 5 times the normal limits for age within 14 days of the pre-treatment scan White blood cell count (WCB < 3.0/µL) absolute neutrophil count (ANC) < 1.5/µL Platelets < 75,000/µL Haemoglobin < 10 g/dL unable and unwilling to follow instructions and comply with the protocol unable or unwilling to provide written informed consent prior to participation in the study Karnofsky Performance Scale score <50
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander McEwan, MB, FCRPC
Organizational Affiliation
Professor, Department of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium in Patients With Thyroid Cancer

We'll reach out to this number within 24 hrs