NCT04235114 Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR+ Cancers by Positron Emission Tomography (PET)
| NCT ID | NCT04235114 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Saskatchewan |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2020-02-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 14 participants in total. It began in 2020-02-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. Exclusion Criteria: * Unable to tolerate 60 min of PET imaging per session.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04235114 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04235114 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04235114 currently recruiting?
Yes, NCT04235114 is actively recruiting participants. Contact the research team at rajan.rakheja@gmail.com for enrollment information.
Where is the NCT04235114 trial being conducted?
This trial is being conducted at Saskatoon, Canada.
Who is sponsoring the NCT04235114 clinical trial?
NCT04235114 is sponsored by University of Saskatchewan. The trial plans to enroll 14 participants.
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