Imaging with [89Zr]Panitumumab-PET/MRI in Patients with N... | NCT03764137

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

NCT03764137

Sponsor

University of Alabama at Birmingham

Status

Withdrawn

Last Update Posted

Jan 31, 2025Actual

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Metastatic Colon Cancer

Interventions

[89Zr]Panitumumab PET-MRI

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was not able to enroll any subjects

Expanded Access Info

Start Date

Mar 14, 2019Actual

Primary Completion Date

Jan 2025Estimated

Completion Date

Jan 2026Estimated

First Submitted Date

Nov 1, 2018

First Submission Date that Met QC Criteria

Dec 3, 2018

First Posted Date

Dec 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2025

Last Update Posted Date

Jan 31, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Suzanne E. Lapi, PhD, Director Cyclotron Facility, University of Alabama at BirminghamPrincipal Investigator

Lead Sponsor

University of Alabama at BirminghamOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
[89Zr]Panitumumab-PET/MRI patients	Experimental	All study patients will receive [89Zr]Panitumumab-PET/MRI imaging.	Drug: [89Zr]Panitumumab PET-MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[89Zr]Panitumumab PET-MRI	Drug	All patients entered into the study will have [89Zr]Panitumumab-PET/MRI imaging.	[89Zr]Panitumumab-PET/MRI patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Suzanne Lapi, PhD	University of Alabama at Birmingham	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided