An Imaging Study in Patients With Thyroid Cancer or Head and Neck Cancer With Pertechnetate Made in a Cyclotron (C-PERT)
Conditions
Thyroid Neoplasms - Head and Neck Neoplasms
Conditions: official terms
Head and Neck Neoplasms - Neoplasms - Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
99mTc Pertechnetate, thyroidectomy, thyroid neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: C-PERT Type: Drug
Name: G-PERT Type: Drug
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 79 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Cross Cancer Institute
Edmonton, Alberta, Canada
Status: Not yet recruiting
Contact: Marg Landon - 780 432-8751
Start Date
January 2013
Completion Date
May 2013
Sponsors
Alberta Health Services
Source
AHS Cancer Control Alberta
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page