Primary Malignant Liver NeoplasmNCT03109262
Yttrium-90 (Y90) Glass Microspheres PET/CT in Imaging Patients With Liver Tumors
A study testing Computed Tomography (CT), Positron Emission Tomography (PET) and 90-Yttrium (Y-90) Glass Microspheres in people with Primary Malignant Liver Neoplasm, run by Stanford University at 1 site in United States.
Trial summary
This clinical trial studies how well yttrium-90 (Y90) glass microspheres positron emission tomography (PET)/computed tomography (CT) works in imaging patients with liver tumors . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Malignant Liver Neoplasm
- What is being tested?
- Computed Tomography (CT), Positron Emission Tomography (PET) and 90-Yttrium (Y-90) Glass Microspheres
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient provides written informed consent
- Patient is referred for 90Y SIRT radioembolization of liver tumor(s)
- Patient is capable of complying with study procedures
- Patient is able to remain still for duration of imaging procedure (approximately 30 minutes total for digital PET/CT)
Who cannot join
- Patient is pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Quality Imaging and Dosimetry of Yttrium-90 (90Y) SIRT Using a Digital PET/CT
This clinical trial studies how well yttrium-90 (Y90) glass microspheres positron emission tomography (PET)/computed tomography (CT) works in imaging patients with liver tumors . Images produced by PET/CT may provide better information about the distribution of particles, such as Y90 glass microspheres, delivered for selective internal radiation therapy (SIRT) as compared to regular medical care images useing technetium Tc-99m albumin-aggregated single photon emission computed tomography (SPECT)/CT images.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the image quality of yttrium-90 (Y90) microspheres PET/CT post SIRT images as compared to technetium Tc-99m albumin aggregated (99mTc MAA) SPECT/CT.
SECONDARY OBJECTIVES:
- To determine the superior accuracy in both distribution and dosimetry of Y90 PET/CT post-SIRT imaging compared to 99mTc MAA planar and SPECT/CT imaging.
OUTLINE:
Immediately after standard of care SIRT, patients receive Y90 glass microspheres and undergo PET/CT over 30 minutes.
This study compares the experimental images to the regular medical care images in the same participant.
- Conditions
- Primary Malignant Liver Neoplasm
- Being tested
- Computed Tomography (CT), Positron Emission Tomography (PET), 90-Yttrium (Y-90) Glass Microspheres, Technetium 99mTc albumin aggregated (99mTc-MAA), Single-photon emission computerized tomography (SPECT) scan
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed Tomography (CT)Procedure or surgery
Also called CAT, CAT Scan, Computed Tomography, Computerized Axial Tomography
As part of PET/CT and SPECT/CT scans.
Positron Emission Tomography (PET)Procedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography
As part of PET/CT scan
90-Yttrium (Y-90) Glass MicrospheresDevice
Also called TheraSphere
Radiolabel for PET/CT scan
Technetium 99mTc albumin aggregated (99mTc-MAA)Diagnostic test
Also called 99mTc-MAA
Radiolabel for 99mTc-MAA SPECT/CT Scan
Single-photon emission computerized tomography (SPECT) scanProcedure or surgery
Also called SPECT Scan
As part of SPECT/CT scan
| Study group | Role | What they receive |
|---|---|---|
| Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans | Experimental | All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans Receives: Procedure: Computed Tomography (CT); Procedure: Positron Emission Tomography (PET); Device: 90-Yttrium (Y-90) Glass Microspheres; Diagnostic Test: Technetium 99mTc albumin aggregated (99mTc-MAA); Procedure: Single-photon emission computerized tomography (SPECT) scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality for 90-Y PET/CT Scans
Image quality for 90Y PET/CT scan images was assessed relative to the expected image quality of Standard of Care (SoC) 99mTc-MAA SPECT/CT scans obtained from the same participant. Assessments were conducted at 5, 10, 15 and 20 minutes after infusion. Scans were assessed on a 1 to 5 Likert scale by 2 Nuclear Medicine physicians who were blinded to patient information. The Likert scale for image quality was established as follows:
- = Non-diagnostic
- = Suboptimal
- = Acceptable
- = Good
- = Excellent, equivalent to a SoC 99mTc-MAA SPECT/CT scan The scans for each individual participant at each timepoint was scored on the Likert scale, as determined by the 2 Nuclear Medicine physicians. The outcome is reported as the overall mean of the physician determinations for each time point, with standard deviation.
Measured: 1 day
Secondary outcomes (1)
Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans
Radiopharmaceutical dosimetry was assessed based on the numerical tumor-absorbed dose value in Gray as calculated by SurePlan (MIM Software Inc, Cleveland, Ohio). The outcome is reported as the median tumor-absorbed dose in Gray for each scan method (90Y PET/CT and 99mTc-MAA SPECT/CT), with standard deviation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start15 Feb 2017
- Primary completion30 May 2019
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Malignant Liver NeoplasmStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrei Iagaru, Stanford University
- Investigators
- Andrei Iagaru, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109262
- Sponsor's protocol ID
- IRB-39332
- Other IDs
- NCI-2017-00463, VAR0147
- Status last verified
- Dec 2021
- First submitted
- 6 Apr 2017
- Last updated
- 10 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Duan H, Khalaf MH, Ferri V, Baratto L, Srinivas SM, Sze DY, Iagaru A. High quality imaging and dosimetry for yttrium-90 (90Y) liver radioembolization using a SiPM-based PET/CT scanner. Eur J Nucl Med Mol Imaging. 2021 Jul;48(8):2426-2436. doi: 10.1007/s00259-021-05188-4. Epub 2021 Jan 14.
PubMed 33443618
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Quality Imaging and Dosimetry of Yttrium-90 (90Y) SIRT Using a Digital PET/CT
- ClinicalTrials.gov ID
- NCT03109262
- Acronym / sponsor ID
- IRB-39332
- Conditions
- Primary Malignant Liver Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 9 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies how well yttrium-90 (Y90) glass microspheres positron emission tomography (PET)/computed tomography (CT) works in imaging patients with liver tumors . Images produced by PET/CT may provide better information about the distribution of particles, such as Y90 glass microspheres, delivered for selective internal radiation therapy (SIRT) as compared to regular medical care images useing technetium Tc-99m albumin-aggregated single photon emission computed tomography (SPECT)/CT images.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the image quality of yttrium-90 (Y90) microspheres PET/CT post SIRT images as compared to technetium Tc-99m albumin aggregated (99mTc MAA) SPECT/CT.
SECONDARY OBJECTIVES:
- To determine the superior accuracy in both distribution and dosimetry of Y90 PET/CT post-SIRT imaging compared to 99mTc MAA planar and SPECT/CT imaging.
OUTLINE:
Immediately after standard of care SIRT, patients receive Y90 glass microspheres and undergo PET/CT over 30 minutes.
This study compares the experimental images to the regular medical care images in the same participant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans | Experimental | Procedure: Computed Tomography (CT), Procedure: Positron Emission Tomography (PET), Device: 90-Yttrium (Y-90) Glass Microspheres, Diagnostic Test: Technetium 99mTc albumin aggregated (99mTc-MAA), Procedure: Single-photon emission computerized tomography (SPECT) scanAll participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient provides written informed consent
- Patient is referred for 90Y SIRT radioembolization of liver tumor(s)
- Patient is capable of complying with study procedures
- Patient is able to remain still for duration of imaging procedure (approximately 30 minutes total for digital PET/CT)
Key exclusion criteria (1 listed)
- Patient is pregnant or nursing
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 |
|---|---|---|
| Computed Tomography (CT)Also: CAT, CAT Scan, Computed Tomography, Computerized Axial TomographyAs part of PET/CT and SPECT/CT scans. | Procedure or surgery | Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans |
| Positron Emission Tomography (PET)Also: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission TomographyAs part of PET/CT scan | Procedure or surgery | Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans |
| 90-Yttrium (Y-90) Glass MicrospheresAlso: TheraSphereRadiolabel for PET/CT scan | Device | Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans |
| Technetium 99mTc albumin aggregated (99mTc-MAA)Also: 99mTc-MAARadiolabel for 99mTc-MAA SPECT/CT Scan | Diagnostic test | Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans |
| Single-photon emission computerized tomography (SPECT) scanAlso: SPECT ScanAs part of SPECT/CT scan | Procedure or surgery | Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans |
Primary outcome
Image Quality for 90-Y PET/CT Scans
Time frame: 1 day
Image quality for 90Y PET/CT scan images was assessed relative to the expected image quality of Standard of Care (SoC) 99mTc-MAA SPECT/CT scans obtained from the same participant. Assessments were conducted at 5, 10, 15 and 20 minutes after infusion. Scans were assessed on a 1 to 5 Likert scale by 2 Nuclear Medicine physicians who were blinded to patient information. The Likert scale for image quality was established as follows: 1. = Non-diagnostic 2. = Suboptimal 3. = Acceptable 4. = Good 5. = Excellent, equivalent to a SoC 99mTc-MAA SPECT/CT scan The scans for each individual participant at each timepoint was scored on the Likert scale, as determined by the 2 Nuclear Medicine physicians. The outcome is reported as the overall mean of the physician determinations for each time point, with standard deviation.
1 secondary outcome
Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33443618Duan H, Khalaf MH, Ferri V, Baratto L, Srinivas SM, Sze DY, Iagaru A. High quality imaging and dosimetry for yttrium-90 (90Y) liver radioembolization using a SiPM-based PET/CT scanner. Eur J Nucl Med Mol Imaging. 2021 Jul;48(8):2426-2436. doi: 10.1007/s00259-021-05188-4. Epub 2021 Jan 14.
- Individual participant dataSharing planned: No
Related trials for Primary Malignant Liver Neoplasm
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
Anal Carcinoma, Bladder Carcinoma
Recruiting
Histotripsy for Ablation of Liver Tumours in Asia
Liver Malignant Tumors
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.
Andrei Iagaru principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography (CT), Positron Emission Tomography (PET) and 90-Yttrium (Y-90) Glass Microspheres in people with Primary Malignant Liver Neoplasm, run by Stanford University 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 1 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: finished, as of the sponsor's last update on 10 Jan 2022. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 for 90-Y PET/CT Scans (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03109262, which also lists 1 linked publication.
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 10 Jan 2022.