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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (infusion) to day 7
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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I am not pregnant or nursing, and if I can have children, I tested negative for pregnancy recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (infusion) to day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (infusion) to day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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.

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

Find a Location

Who is running the clinical trial?

University of SaskatchewanLead Sponsor
249 Previous Clinical Trials
154,160 Total Patients Enrolled

Media Library

1 mg 89Zr-DFO-Nimotuzumab Clinical Trial Eligibility Overview. Trial Name: NCT04235114 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Establish Cold Dose, Establish Imaging Time, Diagnostic Quality
Colorectal Cancer Clinical Trial 2023: 1 mg 89Zr-DFO-Nimotuzumab Highlights & Side Effects. Trial Name: NCT04235114 — Phase 1 & 2
1 mg 89Zr-DFO-Nimotuzumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04235114 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research experiment open to individuals of a youthful age?

"This medical trial seeks to enrol those aged 18 or over but less than 80."

Answered by AI

How many participants are eligible for this scientific trial?

"Affirmative, the information hosted on clinicaltrials.gov indicates that this scientific experiment is currently enlisting participants. This study was initially publicized on February 1st 2020 and most recently revised on May 18th 2022. The research necessitates 14 individuals from one medical facility to complete it."

Answered by AI

Is there an ongoing recruitment process for this experiment?

"Per the records on clinicaltrials.gov, this medical trial is actively accruing patients since its initial posting on February 1st 2020 and most recent update occurring May 18th 2022."

Answered by AI

What prior experimentation has taken place surrounding 1 mg 89Zr-DFO-Nimotuzumab?

"At present, 21 clinical trials researching 1 mg 89Zr-DFO-Nimotuzumab are in progress with 6 of them being in the Phase 3 stage. These studies are mainly centered around Changsha, Hunan but can also be found at 65 different locations globally."

Answered by AI

What criteria must be met to qualify for participation in this experiment?

"This clinical trial requires participants to have colorectal cancer and be between 18-80 years old. A total of 14 individuals are sought for this research endeavor."

Answered by AI

What conditions can be treated with the 1 mg 89Zr-DFO-Nimotuzumab dosage?

"Clinicians are utilizing 1 mg 89Zr-DFO-Nimotuzumab to treat relapsing cases and advanced head & neck cancer, glioblastoma multiforme (GBM), and carcinomas."

Answered by AI
~5 spots leftby Sep 2026