Recruiting

Phase 1

Phase 2

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

Sponsor:

University of Saskatchewan

Code:

NCT04235114

Conditions

Lung Cancer

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

50 mg 89Zr-DFO-Nimotuzumab

1 mg 89Zr-DFO-Nimotuzumab

Study Details

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.

Conditions

Lung Cancer

Colorectal Cancer

Study ID

NCT04235114

Start date

Feb 1, 2020

Status verified date

Jan, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

14 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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

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

Interventions

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.

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.

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Rajan Rakheja, MD

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

Locations

Royal University Hospital

Recruiting

Saskatoon, Saskatchewan, Canada

More Information

Sponsor

University of Saskatchewan

Last update posted

Jan 9, 2024

Last verified

Jan, 2024

Keywords

89Zr
Nimotuzumab
Lung cancer
Colorectal cancer
EGFR
PET
PET/CT
Imaging
89Zr-DFO-nimotuzumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2024-01-09.