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

Primary Purpose

Lung Cancer, Colorectal Cancer

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
50 mg 89Zr-DFO-Nimotuzumab
1 mg 89Zr-DFO-Nimotuzumab
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring 89Zr, Nimotuzumab, Lung cancer, Colorectal cancer, EGFR, PET, PET/CT, Imaging, 89Zr-DFO-nimotuzumab

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Establish Imaging Time

Diagnostic Quality

Establish Cold Dose

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

The observation of differences in 89Zr-DFO-nimotuzumab uptake between the tumors and normal tissues using PET/CT.

Secondary Outcome Measures

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.

Full Information

First Posted
October 13, 2018
Last Updated
May 18, 2022
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT04235114
Brief Title
Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR+ Cancers by Positron Emission Tomography (PET)
Official Title
Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR Positive Cancers by Positron Emission Tomography (PET)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Colorectal Cancer
Keywords
89Zr, Nimotuzumab, Lung cancer, Colorectal cancer, EGFR, PET, PET/CT, Imaging, 89Zr-DFO-nimotuzumab

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Establish Imaging Time
Arm Type
Experimental
Arm Description
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
Arm Title
Diagnostic Quality
Arm Type
Experimental
Arm Description
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
Arm Title
Establish Cold Dose
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
50 mg 89Zr-DFO-Nimotuzumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
1 mg 89Zr-DFO-Nimotuzumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rajan Rakheja, MD
Phone
306-655-2932
Email
rajan.rakheja@gmail.com
Facility Information:
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Geyer, PhD
First Name & Middle Initial & Last Name & Degree
Humphrey Fonge, PhD
First Name & Middle Initial & Last Name & Degree
Kris Barreto, PhD
First Name & Middle Initial & Last Name & Degree
Wendy Bernhard, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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