Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR+ Cancers by Positron Emission Tomography (PET)

Colorectal Cancer Clinical Trial

Official title:

Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR Positive Cancers by Positron Emission Tomography (PET)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04235114
• Other study ID #: Bio 17-288
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 1, 2020
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: University of Saskatchewan
• Contact: Rajan Rakheja, MD
• Phone: 306-655-2932
• Email: rajan.rakheja[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Lung Cancer

Intervention

Drug:
• 50 mg 89Zr-DFO-Nimotuzumab
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-Nimotuzumab
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.

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The observation of differences in 89Zr-DFO-nimotuzumab uptake between the tumors and normal tissues using PET/CT.		baseline (infusion) to day 7
Secondary	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