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

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ClinicalTrials.gov Identifier: NCT04235114
Recruitment Status : Recruiting
First Posted : January 21, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Rajan Rakheja, University of Saskatchewan

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lung Cancer Colorectal Cancer Drug: 89Zr-DFO-Nimotuzumab Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR Positive Cancers by Positron Emission Tomography (PET)
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : August 2022

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Arms and Interventions
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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: 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: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04235114


Contacts
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Contact: Rajan Rakheja, MD 306-655-2932 rajan.rakheja@gmail.com

Locations
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Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada
Sub-Investigator: Ronald Geyer, PhD         
Sub-Investigator: Humphrey Fonge, PhD         
Sponsors and Collaborators
University of Saskatchewan
More Information
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Responsible Party: Rajan Rakheja, Clinical Assistant Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT04235114    
Other Study ID Numbers: Bio 17-288
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rajan Rakheja, University of Saskatchewan:
89Zr
Nimotuzumab
Lung cancer
Colorectal cancer
EGFR
 PET
PET/CT
Imaging
89Zr-DFO-nimotuzumab
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Nimotuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents