Imaging EGFR-positive lung and colorectal cancers with a radioactive nimotuzumab scan
Tests a radioactive antibody scan to detect EGFR-positive tumors in lung or colorectal cancer.
Key facts
- Who runs it
- University of Saskatchewan
- Where
- Saskatoon, CanadaSee the site
- Trial code
- Registry title
- Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR+ Cancers by Positron Emission Tomography (PET)
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 14 people, planned
- Started
- 1 Feb 2020
- Expected to end
- Dec 2026
- Type of study
- Interventional, 3 groups
- Treatments tested
- 50 mg 89Zr-DFO-Nimotuzumab
- 1 mg 89Zr-DFO-Nimotuzumab
- Record updated
- 9 January 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 with an EGFR-positive cancer. They will have PET/CT scans with 89Zr-DFO-nimotuzumab to see if the tumor can be imaged.
- Age
- 18 to 80 years
- Sex
- Women and men can join.
- Disease stage
- EGFR-positive cancer confirmed by a board certified pathologist. The main or spread tumor must be at least 1.5 cm (0.6 in) on imaging or physical examination.
- Earlier treatment
- People must not have had anti-EGFR antibody treatment before.
- Biomarker or test result
- EGFR-positive cancer, as defined by a board certified pathologist.
Main reasons for not taking part
- Cannot lie through 60 minutes of PET imaging per session
- Pregnant or nursing women
- Women of childbearing age with a positive urine pregnancy test in the 24 hours before the dose
- Previous treatment with anti-EGFR antibodies
- WHO performance status above 2
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- Unable to tolerate 60 min of PET imaging per session
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Canada
- Royal University HospitalSaskatoon, CanadaContact: Ronald Geyer, PhD (sub-investigator)Taking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 3 groups in the trial
- Establish Imaging TimeTreatment being tested
Participants will receive an i.v. injection of 50 mg 2 mCi 89Zr-DFO-nimotuzumab. Participants will undergo imaging at four different time points till day 7 after infusion. Vitals, blood sample and urine sample will be collected every time before imaging. Participants will be followed up for any adverse event until day 30 post administration
Treatment: 50 mg 89Zr-DFO-Nimotuzumab
- Diagnostic QualityTreatment being tested
Participants will receive an i.v. injection of 50 mg 2 mCi 89Zr-DFO-nimotuzumab. Participants will undergo imaging once at the best time calculated from arm 1 participants. Vitals, blood sample and urine sample will be collected before imaging. Participants will be followed up for any adverse event until day 30 post administration
Treatment: 50 mg 89Zr-DFO-Nimotuzumab
- Establish Cold DoseTreatment being tested
Participants will receive an i.v. injection of 1 mg 2 mCi 89Zr-DFO-nimotuzumab. Participants will undergo imaging at four different time points till day 7 after infusion. Vitals, blood sample and urine sample will be collected every time before imaging. Participants will be followed up for any adverse event until day 30 post administration
Treatment: 1 mg 89Zr-DFO-Nimotuzumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR Positive Cancers by Positron Emission Tomography (PET)
- Plain-language title
- Imaging EGFR-positive lung and colorectal cancers with a radioactive nimotuzumab scanGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04235114, who can take part
- Record updated
- 9 January 2024