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89Zr-DFO-nimotuzumab for Lung and Colorectal Cancer

Phase 1 & 2

Recruiting

Research Sponsored by University of Saskatchewan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients naïve to anti-EGFR antibodies treatment.

Primary or metastatic lesion size >= 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination.

Must not have

Unable to tolerate 60 min of PET imaging per session.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to show that a certain imaging technique can help doctors better understand how aggressive a cancer is and if a patient will respond to a certain treatment.

Who is the study for?

This trial is for adults aged 18-80 with EGFR-positive lung or colorectal cancer who haven't been treated with anti-EGFR antibodies. They must be in good health, not pregnant or nursing, able to consent, and have a tumor size of at least 1.5 cm. It's not suitable for those unable to undergo a 60-minute PET scan.

What is being tested?

The study tests if the drug 89Zr-DFO-nimotuzumab can help image cancers expressing EGFR using PET/CT scans non-invasively. Participants will receive either a high (50 mg) or low (1 mg) dose of the drug to determine its effectiveness and optimal imaging time.

What are the potential side effects?

Potential side effects are not detailed here but may include reactions related to the infusion process and possible allergic responses due to the presence of foreign substances from the imaging agent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never been treated with anti-EGFR antibodies.

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My cancer has a tumor or spread that is at least 1.5 cm big.

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My cancer is EGFR-positive, as confirmed by a specialist.

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I am between 18 and 80 years old.

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I can take care of myself and perform light activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot stay still for 60 minutes during a PET scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Establish Imaging TimeExperimental Treatment1 Intervention

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

Group II: Establish Cold DoseExperimental Treatment1 Intervention

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

Group III: Diagnostic QualityExperimental Treatment1 Intervention

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

0 / 6Eligibility criteria met