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A Prospective Phase I Study of Cyclotron-produced Tc-99m Pertechnetate (CPERT) in Patients With Thyroid Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Natural Resources, Canada
Edmonton PET Centre
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT01437254
First received: September 19, 2011
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

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 one CPTERT [cyclotron made] Tc-99m Pertechnetate scan after surgery. Vital signs and blood work, pre-injection and post-imaging will be done. The second group of 20 subjects (2 for each CPERT subject) will be matched as to age and gender and have a GPERT scan for qualitative comparison.


Condition Intervention Phase
Thyroid Neoplasms
 Drug: CPERT
Drug: GPERT
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium in Patients With Thyroid Cancer

Resource links provided by NLM:

Drug Information available for: Thyroid
U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • Safety of CPERT [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    The whole body biodistribution pattern of CPERT will be compared to GPERT using two independent and blinded Nuclear Medicine physicians.


Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm Number 1 CPERT
1 CPERT scan, blood and vital sign collection
 Drug: CPERT
Single 340 MBq CPERT scan in first 10 subjects
Active Comparator: Arm Number 2 GPERT
1 GPERT Scan
 Drug: GPERT
Single 340 MBq GPERT scan in up to 20 case-matched controls

Detailed Description:

The Canadian Government supports R&D into alternative methods of medical isotope production that [1] do not require the construction of new nuclear reactors, [2] are not dependent on government subsidies and [3] will lead to a RP market. The cyclotron production model of pertechnetate (CPERT) has received significant validation. The University of Alberta's Edmonton PET Center and the ERC is a cyclotron/radiopharmacy unit, providing a safe, cost effective, unsubsidized and reliable supply of RPs.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 teh study
  • Karnofsky Performance Scale score <50
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437254

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Alberta Health Services
Natural Resources, Canada
Edmonton PET Centre
Investigators
Principal Investigator: AJB McEwan, Msc, MB, BS FRCP Canada
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT01437254     History of Changes
Other Study ID Numbers: DX-CPERT-001/Ethics 25831
Study First Received: September 19, 2011
Last Updated: December 10, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
99mTc Pertechnetate
thyroidectomy

Additional relevant MeSH terms:
Neoplasms
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
 Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013