Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR+ Cancers by Positron Emission Tomography (PET)
Recruiting now Phase 1/2 NCT04235114
Run by University of Saskatchewan · for 18 to 80 · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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.
- Not currently pregnant or nursing: If female subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for > 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test is negative when taken within the 24 h before administration of 89Zr-DFO-nimotuzumab.
- WHO performance status of 0 - 2
- Patients naïve to anti-EGFR antibodies treatment.
🚫 You may not be able to join if…
- Unable to tolerate 60 min of PET imaging per session.
Where this trial is running
- Royal University Hospital, Saskatoon, Saskatchewan, Canada
Who to contact
Rajan Rakheja, MD · 306-655-2932 · rajan.rakheja@gmail.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04235114.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.