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)

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 Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Lung Cancer
• Intervention / Treatment: Drug: 50 mg 89Zr-DFO-Nimotuzumab; Drug: 1 mg 89Zr-DFO-Nimotuzumab

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Rajan Rakheja, MD; Phone Number: 306-655-2932; Email: rajan.rakheja@gmail.com

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada
      • Recruiting
      • Royal University Hospital
      • Sub-Investigator: Ronald Geyer, PhD
      • Sub-Investigator: Humphrey Fonge, PhD
      • Sub-Investigator: Kris Barreto, PhD
      • Sub-Investigator: Wendy Bernhard, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Establish Imaging Time; 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	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.
Experimental: Diagnostic Quality; 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	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.
Experimental: Establish Cold Dose; 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	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The observation of differences in 89Zr-DFO-nimotuzumab uptake between the tumors and normal tissues using PET/CT.	baseline (infusion) to day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Saskatchewan

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 13, 2018
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Imaging; PET/CT; Colorectal cancer; PET; Lung cancer; EGFR; 89Zr; Nimotuzumab; 89Zr-DFO-nimotuzumab
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Nimotuzumab
• Other Study ID Numbers: Bio 17-288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No