Lung CancerPhase 1/2NCT04235114
Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR+ Cancers by Positron Emission Tomography (PET)
A Phase 1/2 study testing 50 mg 89Zr-DFO-Nimotuzumab and 1 mg 89Zr-DFO-Nimotuzumab in people with Lung Cancer and Colorectal Cancer, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Colorectal Cancer
- What is being tested?
- 50 mg 89Zr-DFO-Nimotuzumab and 1 mg 89Zr-DFO-Nimotuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2020to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Unable to tolerate 60 min of PET imaging per session.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Royal University Hospital
Saskatoon, Saskatchewan
Ronald Geyer, PhD
Humphrey Fonge, PhD
About this study
Official title: Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR Positive Cancers by Positron Emission Tomography (PET)
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.
- Conditions
- Lung Cancer, Colorectal Cancer
- Being tested
- 50 mg 89Zr-DFO-Nimotuzumab, 1 mg 89Zr-DFO-Nimotuzumab
- Keywords
- 89Zr, Nimotuzumab, Lung cancer, Colorectal cancer, EGFR, PET, PET/CT, Imaging, 89Zr-DFO-nimotuzumab
- Medical subject headings
- Lung Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mg 89Zr-DFO-NimotuzumabDrug
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-NimotuzumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Establish Imaging Time | Experimental | 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 Receives: Drug: 50 mg 89Zr-DFO-Nimotuzumab |
| Diagnostic Quality | Experimental | 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 Receives: Drug: 50 mg 89Zr-DFO-Nimotuzumab |
| Establish Cold Dose | Experimental | 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 Receives: Drug: 1 mg 89Zr-DFO-Nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The observation of differences in 89Zr-DFO-nimotuzumab uptake between the tumors and normal tissues using PET/CT.
Measured: 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.
Measured: baseline (infusion) to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Feb 2020
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a single center, open-label, phase I/II diagnostic imaging study to assess the diagnostic quality of 89Zr-DFO-nimotuzumab with PET.
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajan Rakheja, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235114
- Sponsor's protocol ID
- Bio 17-288
- Status last verified
- Jan 2024
- First submitted
- 13 Oct 2018
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR Positive Cancers by Positron Emission Tomography (PET)
- ClinicalTrials.gov ID
- NCT04235114
- Acronym / sponsor ID
- Bio 17-288
- Conditions
- Lung Cancer, Colorectal Cancer
- Keywords
- 89Zr, Nimotuzumab, Lung cancer, Colorectal cancer, EGFR, PET, PET/CT, Imaging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a single center, open-label, phase I/II diagnostic imaging study to assess the diagnostic quality of 89Zr-DFO-nimotuzumab with PET.
| Arm | Type | Receives |
|---|---|---|
| Establish Imaging Time | Experimental | Drug: 50 mg 89Zr-DFO-NimotuzumabParticipants 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 |
| Diagnostic Quality | Experimental | Drug: 50 mg 89Zr-DFO-NimotuzumabParticipants 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 |
| Establish Cold Dose | Experimental | Drug: 1 mg 89Zr-DFO-NimotuzumabParticipants 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- Unable to tolerate 60 min of PET imaging per session.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50 mg 89Zr-DFO-NimotuzumabA 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. | Drug | Diagnostic Quality, Establish Imaging Time |
| 1 mg 89Zr-DFO-NimotuzumabA 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. | Drug | Establish Cold Dose |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 50 mg 89Zr-DFO-Nimotuzumab and 1 mg 89Zr-DFO-Nimotuzumab in people with Lung Cancer and Colorectal Cancer, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajan Rakheja, MD (306-655-2932, rajan.rakheja@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.