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

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03764137
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 81.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colon Cancer	Drug: [89Zr]Panitumumab PET-MRI	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Imaging With [89Zr]Panitumumab-PET/MRI in Patients With Newly Diagnosed Colorectal Cancer
• Actual Study Start Date: Mar 14, 2019
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [89Zr]Panitumumab-PET/MRI patients All study patients will receive [89Zr]Panitumumab-PET/MRI imaging.	Drug: [89Zr]Panitumumab PET-MRI; All patients entered into the study will have [89Zr]Panitumumab-PET/MRI imaging.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Advanced Imaging Facility	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Suzanne Lapi, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Suzanne E. Lapi, PhD, Director Cyclotron Facility, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03764137
• Other Study ID Numbers: 300002089
• First Posted: Dec 4, 2018
• Last Update Posted: Oct 15, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms; Panitumumab

Study Results

No Results Posted as of Oct 15, 2021