Clinical trial NCT04235114: Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR+ Cancers by Positron Emission Tomography (PET)
Official title: Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR Positive Cancers by Positron Emission Tomography (PET)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
Colorectal Cancer
Keywords: 89Zr
Nimotuzumab
Lung cancer
Colorectal cancer
EGFR
PET
PET/CT
Imaging
89Zr-DFO-nimotuzumab
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

Primary outcomes:
measure: The observation of differences in 89Zr-DFO-nimotuzumab uptake between the tumors and normal tissues using PET/CT.
timeFrame: baseline (infusion) to day 7
Secondary outcomes:
measure: 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.
timeFrame: baseline (infusion) to day 7
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
References: