Liver NeoplasmsPhase 1NCT01744054
Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization
A Phase 1 study testing PET/MR and PET/CT in people with Liver Neoplasms, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The successful localization of the y90 microspheres by PET/MR and/or PET/CT scans would be a useful tool in individualizing patient care after the radioembolization procedure. The information from a PET/MR or PET/CT scan would allow for early evaluation of the technical success of the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- PET/MR and PET/CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2012to 3 Apr 2017
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must successfully complete the MRI screening form if receiving an MRI
- Participant must be scheduled to undergo radioembolization for any indication
- Participant must be ≥ 18 years of age
- Participant must be able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document
Who cannot join
- Participant must not have any contraindications to MRI scanning
- Patient must not be pregnant or breastfeeding
- If agreeing to MRI contrast, participant must not have renal insufficiency (glomerular filtration rate (GFR < 30 mL/min/1.73 m2) measured within the past 60 days
- If agreeing to MRI contrast, participant must not be on dialysis
- If agreeing to MRI contrast, participant must not have had a prior allergic reaction to gadolinium-based contrast agents
- PET/MRI or PET/CT is not able to be scheduled within 72 hours of radioembolization
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Pilot Study of Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization
The successful localization of the y90 microspheres by PET/MR and/or PET/CT scans would be a useful tool in individualizing patient care after the radioembolization procedure. The information from a PET/MR or PET/CT scan would allow for early evaluation of the technical success of the procedure.
- Conditions
- Liver Neoplasms
- Being tested
- PET/MR, PET/CT
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRDevice
PET/CTDevice
| Study group | Role | What they receive |
|---|---|---|
| PET/MR or PET/CT | Other | * Patients must have had radioembolization, within 72 hours of the PET/MR or PET/CT
* Subjects will be asked to lie still within the scanner for up to 1.5 hours while images are acquired for the liver Receives: Device: PET/MR; Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate y90-PET/MRI and PET/CT for potential on reporting presence of extrahepatic deposition of microspheres
A diagnostic radiologist and a nuclear medicine physician will evaluate the images and will determine any presence of extrahepatic deposition of microspheres.
Measured: 1 day (one time event for patient)
Evaluate y90-PET/MRI and PET/CT for potential on reporting technical success of radioembolization
A diagnostic radiologist and a nuclear medicine physician will evaluate the images and will determine whether technical success of the procedure can be determined. They will rate the images if they are 'adequate' to report on these two measures.
Measured: 1 day (one time event for patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study start25 Oct 2012
- Primary completion3 Apr 2017
- Study completion3 Apr 2017
Why it stopped: Logistics regarding PET/CT portion of study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parag Parikh, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744054
- Sponsor's protocol ID
- 201209062
- Status last verified
- Mar 2018
- First submitted
- 30 Nov 2012
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Microsphere Localization Using PET/MRI or PET/CT in Patients Following Radioembolization
- ClinicalTrials.gov ID
- NCT01744054
- Acronym / sponsor ID
- 201209062
- Conditions
- Liver Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistics regarding PET/CT portion of study
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 25 Oct 2012 (actual)
- Primary completion
- 3 Apr 2017 (actual)
- Study completion
- 3 Apr 2017 (actual)
- First posted
- 6 Dec 2012 (estimated)
- 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.
The successful localization of the y90 microspheres by PET/MR and/or PET/CT scans would be a useful tool in individualizing patient care after the radioembolization procedure. The information from a PET/MR or PET/CT scan would allow for early evaluation of the technical success of the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/MR or PET/CT | Other | Device: PET/MR, Device: PET/CT* Patients must have had radioembolization, within 72 hours of the PET/MR or PET/CT * Subjects will be asked to lie still within the scanner for up to 1.5 hours while images are acquired for the liver |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant must successfully complete the MRI screening form if receiving an MRI
- Participant must be scheduled to undergo radioembolization for any indication
- Participant must be ≥ 18 years of age
- Participant must be able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document
Key exclusion criteria (6 listed)
- Participant must not have any contraindications to MRI scanning
- Patient must not be pregnant or breastfeeding
- If agreeing to MRI contrast, participant must not have renal insufficiency (glomerular filtration rate (GFR < 30 mL/min/1.73 m2) measured within the past 60 days
- If agreeing to MRI contrast, participant must not be on dialysis
- If agreeing to MRI contrast, participant must not have had a prior allergic reaction to gadolinium-based contrast agents
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 |
|---|---|---|
| PET/MR | Device | PET/MR or PET/CT |
| PET/CT | Device | PET/MR or PET/CT |
Primary outcome
Evaluate y90-PET/MRI and PET/CT for potential on reporting presence of extrahepatic deposition of microspheres
Time frame: 1 day (one time event for patient)
A diagnostic radiologist and a nuclear medicine physician will evaluate the images and will determine any presence of extrahepatic deposition of microspheres.
Evaluate y90-PET/MRI and PET/CT for potential on reporting technical success of radioembolization
Time frame: 1 day (one time event for patient)
A diagnostic radiologist and a nuclear medicine physician will evaluate the images and will determine whether technical success of the procedure can be determined. They will rate the images if they are 'adequate' to report on these two measures.
Results and safety
The study was stopped early (reason given: Logistics regarding PET/CT portion of study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Parag Parikh, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PET/MR and PET/CT in people with Liver Neoplasms, run by Washington University School of Medicine at 1 site in United States.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
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 stopped early (reason given: Logistics regarding PET/CT portion of study). Results are not available in the source record.
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?
Evaluate y90-PET/MRI and PET/CT for potential on reporting presence of extrahepatic deposition of microspheres (time frame: 1 day (one time event for patient)). The study lists 2 primary outcomes in all. 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 5 Mar 2018; AzTrials last refreshed its copy on 29 Oct 2026.