NCT04235114RecruitingPhase 1/2
Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR+ Cancers by Positron Emission Tomography (PET)
Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR Positive Cancers by Positron Emission Tomography (PET)
Source: ClinicalTrials.gov · Last updated 9 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 13 Oct 2018
- Start date
- 1 Feb 2020
- Primary completion date
- Sept 2026
- Lead sponsor
- University of Saskatchewan
- Diseases
- Lung cancer, Colorectal cancer
- NCT number
- NCT04235114
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 14
- From 1 Feb 2020 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Unable to tolerate 60 min of PET imaging per session.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal University Hospital Coordinator of this site? Confirm its status | Saskatoon | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.