Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 80Years
All Genders
NCT04235114

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

Led by University of Saskatchewan · Updated on 2024-01-09

14

Participants Needed

1

Research Sites

356 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 naive to anti-EGFR antibodies treatment.
Not Eligible

You will not qualify if you...

  • Unable to tolerate 60 min of PET imaging per session.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Actively Recruiting

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Research Team

R

Rajan Rakheja, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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