Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR+ Cancers by Positron Emission Tomography (PET)
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 lung-cancer
Started Feb 2020
Longer than P75 for phase_1 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2018
CompletedFirst Posted
Study publicly available on registry
January 21, 2020
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 9, 2024
January 1, 2024
6.6 years
October 13, 2018
January 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The observation of differences in 89Zr-DFO-nimotuzumab uptake between the tumors and normal tissues using PET/CT.
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.
baseline (infusion) to day 7
Study Arms (3)
Establish Imaging Time
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
Interventions
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.
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.
Eligibility Criteria
You may qualify 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 qualify if:
- Unable to tolerate 60 min of PET imaging per session.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal University Hospital
Saskatoon, Saskatchewan, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
October 13, 2018
First Posted
January 21, 2020
Study Start
February 1, 2020
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 9, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share