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

AHS Cancer Control Alberta

Status and phase: Withdrawn; Phase 2

Conditions: Thyroid Neoplasms; Head and Neck Neoplasms

Treatments: Drug: C-PERT; Drug: G-PERT

Study type: Interventional

Funder types: Other

Identifiers

NCT01747512

DX-CPERT-002

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 79 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

C-PERT

Active Comparator group

Description:

45 patients with cancer

Treatment:

Drug: C-PERT

G-PERT

Active Comparator group

Description:

65 patients with cancer

Treatment:

Drug: G-PERT