Metastatic Colon CancerPhase 1/2PanitumumabNCT03764137
Imaging with [89Zr]Panitumumab-PET/MRI in Patients with Newly Diagnosed Colorectal Cancer
A Phase 1/2 study testing [89Zr]Panitumumab PET-MRI in people with Metastatic Colon Cancer, run by University of Alabama at Birmingham.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Metastatic Colon Cancer
- What is being tested?
- [89Zr]Panitumumab PET-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2019to Jan 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 19 years of age.
- Diagnosis of colon cancer
- Scheduled to undergo surgical resection
Who cannot join
- 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
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- 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
About this study
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
- Being tested
- [89Zr]Panitumumab PET-MRI
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[89Zr]Panitumumab PET-MRIDrug
All patients entered into the study will have [89Zr]Panitumumab-PET/MRI imaging.
| Study group | Role | What they receive |
|---|---|---|
| [89Zr]Panitumumab-PET/MRI patients | Experimental | All study patients will receive [89Zr]Panitumumab-PET/MRI imaging. Receives: Drug: [89Zr]Panitumumab PET-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start14 Mar 2019
- Primary completionJan 2025 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: Study was not able to enroll any subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colon CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne E. Lapi, PhD, University of Alabama at Birmingham
- Investigators
- Suzanne Lapi, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764137
- Sponsor's protocol ID
- 300002089
- Acronym
- Panitumumab
- Status last verified
- Jan 2025
- First submitted
- 1 Nov 2018
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging with [89Zr]Panitumumab-PET/MRI in Patients with Newly Diagnosed Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03764137
- Acronym / sponsor ID
- Panitumumab / 300002089
- Conditions
- Metastatic Colon Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not able to enroll any subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [89Zr]Panitumumab-PET/MRI patients | Experimental | Drug: [89Zr]Panitumumab PET-MRIAll study patients will receive [89Zr]Panitumumab-PET/MRI imaging. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be at least 19 years of age.
- Diagnosis of colon cancer
- Scheduled to undergo surgical resection
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [89Zr]Panitumumab PET-MRIAll patients entered into the study will have [89Zr]Panitumumab-PET/MRI imaging. | Drug | [89Zr]Panitumumab-PET/MRI patients |
Primary outcome
Image Quality
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Lapi, PhD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [89Zr]Panitumumab PET-MRI in people with Metastatic Colon Cancer, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Quality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.