Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR+ Cancers by Positron Emission Tomography (PET)

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Saskatchewan

About this trial

Over-expression of Epidermal Growth Factor Receptor (EGFR) on cells occurs in all aggressive cancers of epithelial origin. Existing tests for monitoring EGFR expression are invasive and not reliable. There needs to be a better way to measure EGFR expression in cancerous tumors to better tailor cancer treatments.

This clinical trial aims to demonstrate the feasibility of imaging cancers that express EGFR using 89Zr-DFO-nimotuzumab and Positron Emission Tomography (PET)/Computerized Tomography (CT). By non-invasively imaging the status of EGFR, 89Zr-DFO-nimotuzumab could be used to assist in the identification of patients who are likely to respond to anti-EGFR treatments, including nimotuzumab. The hypothesis is that 89Zr-DFO-nimotuzumab will accumulate to tumors over-expressing EGFR making them visible when imaged with PET/CT. This hypothesis will be tested in this study, along with the optimal imaging time and diagnostic ability.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female between 18 and 80 years old.

EGFR-positive cancer defined by a board certified pathologist

Primary or metastatic lesion size >= 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination.

Able to give informed consent.

Disqualifiers

Unable to tolerate 60 min of PET imaging per session.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 50 mg 89Zr-DFO-Nimotuzumab

    Drug

    A maximum of 2 mCi (range 1 - 2 mCi) 50 mg of 89Zr-DFO-nimotuzumab will be injected intravenously over a period of at 2 - 3 minutes. Injection will be followed by a normal saline flush of 20-30 mL. PET/CT scan will be done at different time points post infusion.

  • 1 mg 89Zr-DFO-Nimotuzumab

    Drug

    A maximum of 2 mCi (range 1 - 2 mCi) 1 mg of 89Zr-DFO-nimotuzumab will be injected intravenously over a period of at 2 - 3 minutes. Injection will be followed by a normal saline flush of 20-30 mL. PET/CT scan will be done at different time points post infusion.

Treatment groups

14 Participants
are divided into 3 treatment groups
Group A: Establish Imaging TimeExperimental treatment 1 intervention
Group B: Diagnostic QualityExperimental treatment 1 intervention
Group C: Establish Cold DoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The observation of differences in 89Zr-DFO-nimotuzumab uptake between the tumors and normal tissues using PET/CT.

Time frame
baseline (infusion) to day 7

Secondary outcomes

1

Lesion detection rate of FDG PET/CT compared with 89Zr-DFO-nimotuzumab in patients with EGFR-positive (by IHC) lung and colorectal cancers using PET/CT.

Time frame
baseline (infusion) to day 7

Other outcomes

Sponsors and contacts

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