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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01747512

Enrollment

Registered

2012-12-11

Start date

Unknown

Completion date

Unknown

Last updated

2017-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Neoplasms, Head and Neck Neoplasms

Keywords

99mTc Pertechnetate, thyroidectomy, thyroid neoplasms

Brief 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.

Interventions

DRUGC-PERT

Patients with thyroid and Head and Neck cancer

DRUGG-PERT

Patients with thyroid and Head and Neck cancer

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To evaluate the safety of C-PERT from adverse event data	5 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026