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NCT03764137 Clinical Trial

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

Metastatic Colon Cancer Clinical Trial

— Panitumumab  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03764137
Other study ID # 300002089
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date March 14, 2019
Est. completion date January 2026

Study information
Verified date October 2022
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2026
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Be at least 19 years of age. - Diagnosis of colon cancer - Scheduled to undergo surgical resection 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• [89Zr]Panitumumab PET-MRI
All patients entered into the study will have [89Zr]Panitumumab-PET/MRI imaging.

Locations
Country Name City State
United States UAB Advanced Imaging Facility Birmingham Alabama

Sponsors (1)
Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Image Quality 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. 12 months
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