Metastatic Liver CarcinomaPhase 1NCT03028311
Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer
A Phase 1 study testing Angiography, Computed Tomography and Planar Imaging in people with Metastatic Liver Carcinoma and Stage IV Liver Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies the side effects and best way to perform yttrium Y-90 radioembolization in treating patients with liver cancer that has spread to other places in the body (metastatic). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Liver Carcinoma, Stage IV Liver Cancer, Stage IVA Liver Cancer
- What is being tested?
- Angiography, Computed Tomography and Planar Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2017to 31 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- The ability to understand and sign informed consent
- Any candidate eligible for standard of care Y90 radioembolization for treatment of their primary or metastatic liver tumors
Who cannot join
- Patients with greater than 50% liver tumor burden
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Single Session In-Room Yttrium-90 Radioembolization Diagnostic Angiography and Treatment
This clinical trial studies the side effects and best way to perform yttrium Y-90 radioembolization in treating patients with liver cancer that has spread to other places in the body (metastatic). Yttrium Y-90 radioembolization is a therapy that injects radioactive microspheres directly into an artery that feeds liver tumors to cut off their blood supply. Performing yttrium Y-90 radioembolization in a single session may make treatment faster, minimize patient travel, and decrease the overall cost of the procedure.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the feasibility and safety of same day yttrium-90 radioembolization planning and treatment angiography.
SECONDARY OBJECTIVES:
- To determine the patient costs associated with same diagnostic and treatment compared when compared to the standard two session methodology.
II. To determine the time required to perform the mandatory in-room technetium Tc-99m albumin aggregated (99mTc-MAA) imaging and the associated calculations for the lung shunt fraction and treatment 90Y-microsphere activity.
III. To determine the time for delivery of the therapy 90Y-microsphere radioactivity to the angiography suite after the therapy written directive by the authorized user.
OUTLINE:
The first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging.
All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours.
After completion of study treatment, patients are followed up at 1, 3, and 6 months.
- Conditions
- Metastatic Liver Carcinoma, Stage IV Liver Cancer, Stage IVA Liver Cancer, Stage IVB Liver Cancer
- Being tested
- Angiography, Computed Tomography, Planar Imaging, Radioembolization, Single Photon Emission Computed Tomography
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngiographyProcedure or surgery
Undergo angiography
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Undergo SPECT-CT
Planar ImagingProcedure or surgery
Undergo planar imaging
RadioembolizationRadiation
Also called intra-arterial brachytherapy
Undergo radioembolization
Single Photon Emission Computed TomographyProcedure or surgery
Also called Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECT
Undergo SPECT-CT
Technetium Tc-99m Albumin AggregatedRadiation
Also called Tc 99m-labeled MAA, Technetium Tc 99m-Labeled Macroaggregated Albumin, Technetium Tc-99m Albumin Colloid
Given via arterial catheter
Yttrium Y 90 Resin MicrospheresOther
Also called SIR-Spheres
Given via arterial catheter
| Study group | Role | What they receive |
|---|---|---|
| Treatment (angiography, yttrium Y-90 radioembolization) | Other | The first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging.
All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours. Receives: Procedure: Angiography; Procedure: Computed Tomography; Procedure: Planar Imaging; Radiation: Radioembolization; Procedure: Single Photon Emission Computed Tomography; Radiation: Technetium Tc-99m Albumin Aggregated; Other: Yttrium Y 90 Resin Microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of same day yttrium Y-90 radioembolization planning and treatment angiography
Success will be defined as treatment dose calculated and patient treated on the same day of initial radiation. Feasibility will be defined as at least 9 successful same day treatments. A procedure lasting greater than 4 hours will be considered a failure. The time associated with various aspects of the same-day yttrium Y-90 radioembolization procedure will be determined. Will determine the time and cost for the patient and for MD Anderson Cancer Center between the same day yttrium Y-90-radioembolization treatment and the current standard of care two-day treatment schedule. Success status will be summarized using frequencies and percentages. Success rate will be estimated along with exact 95% confidence interval. Patient characteristics will be summarized using appropriate summary statistics.
Measured: Up to 6 months
Incidence of adverse event assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
The summaries will be overall (severity grades 1 through 5). Actions taken for grade 3 events will also be reported. The summaries will present the number and percentage of patients reporting and adverse event for each classification level as well as the number events reported. Laboratory values will be summarized by the treatment group over time.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start9 Jan 2017
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Liver CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Armeen Mahvash, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028311
- Sponsor's protocol ID
- 2016-0244
- Other IDs
- NCI-2017-00629, 2016-0244, P30CA016672
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2017
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Single Session In-Room Yttrium-90 Radioembolization Diagnostic Angiography and Treatment
- ClinicalTrials.gov ID
- NCT03028311
- Acronym / sponsor ID
- 2016-0244
- Conditions
- Metastatic Liver Carcinoma, Stage IV Liver Cancer, Stage IVA Liver Cancer, Stage IVB Liver Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 23 Jan 2017 (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.
This clinical trial studies the side effects and best way to perform yttrium Y-90 radioembolization in treating patients with liver cancer that has spread to other places in the body (metastatic). Yttrium Y-90 radioembolization is a therapy that injects radioactive microspheres directly into an artery that feeds liver tumors to cut off their blood supply. Performing yttrium Y-90 radioembolization in a single session may make treatment faster, minimize patient travel, and decrease the overall cost of the procedure.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the feasibility and safety of same day yttrium-90 radioembolization planning and treatment angiography.
SECONDARY OBJECTIVES:
- To determine the patient costs associated with same diagnostic and treatment compared when compared to the standard two session methodology.
II. To determine the time required to perform the mandatory in-room technetium Tc-99m albumin aggregated (99mTc-MAA) imaging and the associated calculations for the lung shunt fraction and treatment 90Y-microsphere activity.
III. To determine the time for delivery of the therapy 90Y-microsphere radioactivity to the angiography suite after the therapy written directive by the authorized user.
OUTLINE:
The first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging.
All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours.
After completion of study treatment, patients are followed up at 1, 3, and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (angiography, yttrium Y-90 radioembolization) | Other | Procedure: Angiography, Procedure: Computed Tomography, Procedure: Planar Imaging, Radiation: Radioembolization, Procedure: Single Photon Emission Computed Tomography, Radiation: Technetium Tc-99m Albumin Aggregated, Other: Yttrium Y 90 Resin MicrospheresThe first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging. All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The ability to understand and sign informed consent
- Any candidate eligible for standard of care Y90 radioembolization for treatment of their primary or metastatic liver tumors
Key exclusion criteria (1 listed)
- Patients with greater than 50% liver tumor burden
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 |
|---|---|---|
| AngiographyUndergo angiography | Procedure or surgery | Treatment (angiography, yttrium Y-90 radioembolization) |
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, computerized tomographyUndergo SPECT-CT | Procedure or surgery | Treatment (angiography, yttrium Y-90 radioembolization) |
| Planar ImagingUndergo planar imaging | Procedure or surgery | Treatment (angiography, yttrium Y-90 radioembolization) |
| RadioembolizationAlso: intra-arterial brachytherapyUndergo radioembolization | Radiation | Treatment (angiography, yttrium Y-90 radioembolization) |
| Single Photon Emission Computed TomographyAlso: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECTUndergo SPECT-CT | Procedure or surgery | Treatment (angiography, yttrium Y-90 radioembolization) |
| Technetium Tc-99m Albumin AggregatedAlso: Tc 99m-labeled MAA, Technetium Tc 99m-Labeled Macroaggregated Albumin, Technetium Tc-99m Albumin ColloidGiven via arterial catheter | Radiation | Treatment (angiography, yttrium Y-90 radioembolization) |
| Yttrium Y 90 Resin MicrospheresAlso: SIR-SpheresGiven via arterial catheter | Other | Treatment (angiography, yttrium Y-90 radioembolization) |
Primary outcome
Success of same day yttrium Y-90 radioembolization planning and treatment angiography
Time frame: Up to 6 months
Success will be defined as treatment dose calculated and patient treated on the same day of initial radiation. Feasibility will be defined as at least 9 successful same day treatments. A procedure lasting greater than 4 hours will be considered a failure. The time associated with various aspects of the same-day yttrium Y-90 radioembolization procedure will be determined. Will determine the time and cost for the patient and for MD Anderson Cancer Center between the same day yttrium Y-90-radioembolization treatment and the current standard of care two-day treatment schedule. Success status will be summarized using frequencies and percentages. Success rate will be estimated along with exact 95% confidence interval. Patient characteristics will be summarized using appropriate summary statistics.
Incidence of adverse event assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 6 months
The summaries will be overall (severity grades 1 through 5). Actions taken for grade 3 events will also be reported. The summaries will present the number and percentage of patients reporting and adverse event for each classification level as well as the number events reported. Laboratory values will be summarized by the treatment group over time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Metastatic Liver Carcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
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
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
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.
Armeen Mahvash principal investigator
M.D. Anderson Cancer Center
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 Angiography, Computed Tomography and Planar Imaging in people with Metastatic Liver Carcinoma and Stage IV Liver Cancer, run by M.D. Anderson Cancer Center 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 2 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Success of same day yttrium Y-90 radioembolization planning and treatment angiography (time frame: Up to 6 months). 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 16 Sep 2026.