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A Phase II/III Study of Cyclotron-produced Tc-99m Pertechnetate (C-PERT) Efficacy and Safety in Patients With Conformed and Suspected Thyroid Cancer or Head and Neck Cancer


Phase 2
18 Years
79 Years
Not Enrolling
Both
Thyroid Neoplasms, Head and Neck Neoplasms

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Trial Information

A Phase II/III Study of Cyclotron-produced Tc-99m Pertechnetate (C-PERT) Efficacy and Safety in Patients With Conformed and Suspected Thyroid Cancer or Head and Neck Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To demonstrate the efficacy of C-PERT (manufactured by the Edmonton PET Centre/ERC) in comparison to G-PERT (fromm approved commercial sources) using qualitative and quantitative clinical imaging biodistribtion data.

Outcome Time Frame:

5 months

Safety Issue:

No

Principal Investigator

AJB McEwan, MB

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, Cross Cancer Institute, Cancer Care, Alberta Health Services

Authority:

Canada: Health Canada

Study ID:

DX-CPERT-002

NCT ID:

NCT01747512

Start Date:

January 2013

Completion Date:

May 2013

Related Keywords:

  • Thyroid Neoplasms
  • Head and Neck Neoplasms
  • 99mTc Pertechnetate
  • thyroidectomy
  • thyroid neoplasms
  • Neoplasms
  • Thyroid Neoplasms
  • Head and Neck Neoplasms
  • Thyroid Diseases

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