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NCT01747512 Clinical Trial

An Imaging Study in Patients With Thyroid Cancer or Head and Neck Cancer With Pertechnetate Made in a Cyclotron (C-PERT)

Head and Neck Neoplasms Clinical Trial

Official title:
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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01747512
Other study ID # DX-CPERT-002
Secondary ID
Status Withdrawn
Phase Phase 2
First received December 10, 2012
Last updated November 10, 2017

Study information
Verified date November 2017
Source AHS Cancer Control Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 79 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• C-PERT
Patients with thyroid and Head and Neck cancer
• G-PERT
Patients with thyroid and Head and Neck cancer

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
AHS Cancer Control Alberta Cross Cancer Institute

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 5 months
Secondary To evaluate the safety of C-PERT from adverse event data 5 months
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