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

Primary Purpose

Metastatic Colon Cancer

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[89Zr]Panitumumab PET-MRI
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metastatic Colon Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UAB Advanced Imaging Facility

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[89Zr]Panitumumab-PET/MRI patients

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 1, 2018
Last Updated
October 5, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03764137
Brief Title
Imaging With [89Zr]Panitumumab-PET/MRI in Patients With Newly Diagnosed Colorectal Cancer
Acronym
Panitumumab
Official Title
Imaging With [89Zr]Panitumumab-PET/MRI in Patients With Newly Diagnosed Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not able to enroll any subjects
Study Start Date
March 14, 2019 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colon Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
[89Zr]Panitumumab-PET/MRI patients
Arm Type
Experimental
Arm Description
All study patients will receive [89Zr]Panitumumab-PET/MRI imaging.
Intervention Type
Drug
Intervention Name(s)
[89Zr]Panitumumab PET-MRI
Intervention Description
All patients entered into the study will have [89Zr]Panitumumab-PET/MRI imaging.
Primary Outcome Measure Information:
Title
Image Quality
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Lapi, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Advanced Imaging Facility
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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