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

Phase 2RecruitingNCT04235114

University of Saskatchewan14 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Lung Cancer Colorectal Cancer

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Royal University Hospital

Saskatoon, Saskatchewan, Canada

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Rajan Rakheja, MD

CONTACT

306-655-2932 rajan.rakheja@gmail.com

Data from ClinicalTrials.gov

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