NCT01437254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

September 19, 2011

Last Update Submit

November 10, 2017

Conditions

Thyroid Neoplasms

Keywords

99mTc Pertechnetatethyroidectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 months

Secondary Outcomes (1)

  • Comparison of general biodistribution of CPERT and GPERT.

    7 months

Study Arms (2)

Arm Number 1 CPERT

EXPERIMENTAL

1 CPERT scan, blood and vital sign collection

Drug: CPERT

Arm Number 2 GPERT

ACTIVE COMPARATOR

1 GPERT Scan

Drug: GPERT

Interventions

CPERTDRUG

Single 340 MBq CPERT scan in first 10 subjects

Arm Number 1 CPERT
GPERTDRUG

Single 340 MBq GPERT scan in up to 20 case-matched controls

Arm Number 2 GPERT

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Alexander McEwan, MB, FCRPC

    Professor, Department of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The Nuclear Medicine physicians interpreting the whole body biodistribution pattern of CPERT and GPERT scans were blinded.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2011

First Posted

September 20, 2011

Study Start

October 1, 2011

Primary Completion

April 1, 2012

Study Completion

January 1, 2015

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

CA(1)