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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):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT01437254
First received: September 19, 2011
Last updated: September 29, 2014
Last verified: September 2014
  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:


Further study details as provided by AHS Cancer Control Alberta:

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: September 2015
Estimated Primary Completion Date: September 2015 (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
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: NCT01437254

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

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01437254     History of Changes
Other Study ID Numbers: DX-CPERT-001/Ethics 25831
Study First Received: September 19, 2011
Last Updated: September 29, 2014
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on November 27, 2014