Imaging With [89Zr]Panitumumab-PET/MRI in Patients With Newly Diagnosed Colorectal Cancer

Phase 1

Withdrawn

• Conditions: Metastatic Colon Cancer
• Interventions: Drug: [89Zr]Panitumumab PET-MRI

• Registration Number: NCT03764137
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

This clinical study will investigate the utility of PET imaging with \[89Zr\]Panitumumab for imaging of EGFR expression in newly diagnosed colon cancer patients to assess lymph node involvement. If promising, this data will be used to design larger trials.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Study Start: 2019-03-14
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-07
• Primary Completion: 2025-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Be at least 19 years of age.
• Diagnosis of colon cancer
• Scheduled to undergo surgical resection

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Exclusion Criteria

• Inability to provide informed consent
• Pregnancy
• Inability to lie still for the imaging study
• Weight over 350 lbs., due to the scanner bore size
• Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
• Inability to receive Omnipaque (iohexol) iodinated contrast
• Inability to receive glucagon
• Inability to receive Eovist (gadoxetate disodium) gadolinium based contrast agent
• Allergy to contrast imaging agents
• Finding or suspicion of distant metastases on CT

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[89Zr]Panitumumab-PET/MRI patients	[89Zr]Panitumumab PET-MRI	All study patients will receive \[89Zr\]Panitumumab-PET/MRI imaging.

Primary Outcome Measures

Name	Time	Method
Image Quality	12 months	Diagnostic image quality of \[89Zr\]Panitumumab PET imaging in patients with newly diagnosed colon cancer with nodal involvement. Standardized Uptake Values (SUVs) will be measured.

Trial Locations

Locations (1)

UAB Advanced Imaging Facility; 🇺🇸 Birmingham, Alabama, United States