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

NCT03764137 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 300002089
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Colon Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

[89Zr]Panitumumab-PET/MRI patients

EXPERIMENTAL

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

Drug: [89Zr]Panitumumab PET-MRI

Interventions

[89Zr]Panitumumab PET-MRI DRUG

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

[89Zr]Panitumumab-PET/MRI patients

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Suzanne Lapi, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Cyclotron Facility

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: December 4, 2018
• Study Start: March 14, 2019
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share