HCC - Hepatocellular CarcinomaPhase 2MARGINNCT07586046
Defining the Ablative Dose for Y-90 TARE
A Phase 2 study testing Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheres in people with HCC - Hepatocellular Carcinoma, run by Northwestern University at 1 site in United States.
Trial summary
This study is being done to help doctors improve how they treat liver tumors that cannot be removed by surgery or treated with standard ablation techniques. The researchers want to find out the best amount of radiation that needs to be delivered to completely destroy (or ablate) parts of the liver that have cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- What is being tested?
- Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheres
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2026to May 2029
- Phase
- Phase 2
- 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
- Diagnosis of hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver-dominant metastatic disease not amenable to surgical resection or ablation.
- Age ≥18 years.
- Child-Pugh class A or B liver function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate organ and bone marrow function as defined below:
- Leukocytes (WBC) ≥ 3,000/mcL
Show all 14Show fewer
- Absolute neutrophil count (ANC) ≥ 1,500/mcL
- Hemoglobin ≥ 9 g/dL
- Platelets ≥ 50,000/mcL
- Total bilirubin ≤ 3.0 mg/dL
- AST ≤ 100 U/L, ALT ≤ 120 U/L
- Creatinine ≤ 2.0 mg/dL or estimated GFR ≥ 40 mL/min/1.73 m²
- Ability to undergo imaging and laboratory evaluations required by the study.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Extrahepatic metastases.
- Pregnant or breastfeeding individuals.
- Tumors requiring treatment of more than two Couinaud segments.
- Known hypersensitivity to gadolinium-based contrast agents.
- Contraindications to MRI (e.g., incompatible pacemakers, claustrophobia unresponsive to sedation).
- Coagulopathy or clinical instability precluding angiographic intervention.
Show all 9Show fewer
- Prisoners or individuals under legal custody.
- Adults unable to consent.
- Individuals under 18 years of age.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Andrew C Gordon, MD, PhD, (561)703-0134, andrew.gordon@nm.org
Saad Abu Zahra, MD, 646-996-2817, saad.abuzahra@northwestern.edu
About this study
Official title: A Prospective Dose-Escalation Study to Define an Ablative Dose of Yttrium-90 Transarterial Radioembolization Using Advanced Dosimetry and Functional MRI (MARGIN Study)
This study is being done to help doctors improve how they treat liver tumors that cannot be removed by surgery or treated with standard ablation techniques. The researchers want to find out the best amount of radiation that needs to be delivered to completely destroy (or ablate) parts of the liver that have cancer.
Read the detailed description
Currently, doctors use Yttrium-90 (Y90) radiation segmentectomy, a treatment that delivers tiny radioactive beads into the blood vessels feeding the liver tumor. These beads give off radiation that helps kill the cancer cells from the inside, right where the tumor is located. This approach allows doctors to target the tumor very precisely, while keeping the rest of the liver as healthy as possible. However, the exact dose needed to fully ablate a tumor without damaging healthy liver tissue is not well established.
To answer this, the study team will use specialized imaging before and after treatment to evaluate how the radiation is distributed in the liver and how the liver responds over time. These imaging procedures include PET/CT or PET/MRI scans, which are standard medical imaging tests that are not considered experimental. During these scans, a small amount of a safe radioactive substance is injected into a participant's vein. This helps show where the Y90 beads are located in the participant's liver.
In a PET/CT scan, two types of imaging are performed during the same session. The PET scan detects signals from the radioactive substance and shows how the participant's liver is functioning at a molecular level. The CT scan, which uses x-rays to create detailed cross-sectional images of the body, provides a precise anatomical map that helps localize these functional signals. Together, they give a clear picture of both the structure and activity within the liver.
PET/MRI works similarly but uses magnetic fields and radio waves instead of x-rays. It combines the functional information from the PET scan with the highly detailed soft-tissue images from MRI, which can be especially useful in evaluating the liver. Both imaging techniques are done during a single visit, with the PET component typically performed at the same time as the CT or MRI, depending on which machine is used. Participants will also undergo a liver MRI with dual contrast using Eovist and extracellular gadolinium, another standard imaging procedure. MRI uses magnets and radio waves to take detailed pictures of the liver. Eovist is a special dye injected into a participant's vein during the scan that helps highlight liver tissue and shows how well different parts of the liver are functioning. Extracellular gadolinium is a more general contrast agent that enhances blood vessels and tissues, providing complementary information. This imaging helps the doctors confirm whether the tumor area was completely treated.
The goal is to determine the safest and most effective dose of radiation to fully treat cancer while preserving healthy liver tissue. This information may help doctors treat future patients more precisely and safely.
Yttrium-90 and the imaging methods used in this study, including PET/CT, PET/MRI, and dual contrast MRI, are FDA-approved.
- Conditions
- HCC - Hepatocellular Carcinoma
- Being tested
- Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheres
- Keywords
- MARGIN, HCC, Y90, Liver Cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Margins of Excision, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheresOther
The objective of this study is to define an optimal "ablative dose" range for Y90 Radiation Segmentectomy that achieves complete sectoral ablation detectable on dual contrast MRI and to determine whether this dose-response relationship differs between cirrhotic and non-cirrhotic patients.
| Study group | Role | What they receive |
|---|---|---|
| Cirrhotic | Active comparator | Cirrhotic patients will begin at 300 Gy. Dose escalation will proceed in 100 Gy increments within each arm, with safety continuously evaluated by the Data Safety Monitoring Committee Receives: Other: Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheres |
| Non-cirrhotic | Active comparator | Non-cirrhotic patients will begin at a dose of 200 Gy. Dose escalation will proceed in 100 Gy increments within each arm, with safety continuously evaluated by the Data Safety Monitoring Committee. Receives: Other: Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ablative Dose Threshold for Y90 Radiation Segmentectomy
To prospectively define the "ablative dose" threshold for Y90 Radiation Segmentectomy (RS) using post-treatment PET dosimetry and hepatobiliary phase MRI
Measured: From enrollment to the end of post-treatment Y90 12 month follow up visit
Impact of Cirrhosis on Ablative Dose Requirements
To determine whether cirrhotic patients require a higher threshold dose for ablation compared to non- cirrhotic patients
Measured: From enrollment to enrollment to post-treatment Y-90 12 month follow-up visit
Secondary outcomes (3)
Correlation of Y90 Dose with Imaging Biomarkers
To evaluate the correlation between delivered Y90 dose and imaging biomarkers, including signal loss on hepatobiliary phase MRI, ablative margins, extracellular volume fraction, and perfusion changes
Measured: Assessed at 1, 4-9, and 12 month follow up visits
Tumor Response and Time-to-Progression Assessment
To assess tumor response by mRECIST and determine time to progression (TTP)
Measured: From enrollment to end of post-treatment Y-90 12 month follow up visit
Safety and Tolerability of Escalating Y90 Doses
To assess the safety and tolerability of escalating segmental Y90 doses (200- 500 Gy) using Bayesian optimal interval (BOIN) dose-escalation design under Data and Safety Monitoring Committee (DSMC) oversight
Measured: From enrollment to end of post-treatment Y90 12 month follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start15 May 2026
- Primary completionFeb 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Northwestern 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The investigators hypothesize that an optimal ablative dose exists between 200-500 Gy, with increasing ablation rates as dose increases, and that the threshold dose to achieve ablation differs between cirrhotic and non-cirrhotic livers. This hypothesis will be tested using voxel-based Y90 PET dosimetry and hepatobiliary MRI to assess dose-response relationships in both structural and functional imaging endpoints. Non-cirrhotic patients will begin at a dose of 200 Gy, while cirrhotic patients will begin at 300 Gy. Dose escalation will proceed in 100 Gy increments within each arm, with safety continuously evaluated by the Data Safety Monitoring Committee.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Radiological Society of North America, Robert H. Lurie Cancer Center
- Responsible party
- Principal investigator, Andrew Gordon, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586046
- Sponsor's protocol ID
- STU00224943
- Acronym
- MARGIN
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gordon AC, Gates VL, White SB, Harris KR, Procissi D, Zhang Z, Li W, Samaan D, Nicolai JR, Mouli SK, Sato KT, Ryu RK, Omary RA, Salem R, Lewandowski RJ, Larson AC. Correlation and Agreement of Yttrium-90 Positron Emission Tomography/Computed Tomography with Ex Vivo Radioembolization Microsphere Deposition in the Rabbit VX2 Liver Tumor Model. J Vasc Interv Radiol. 2021 Jan;32(1):23-32.e1. doi: 10.1016/j.jvir.2020.09.016. Epub 2020 Nov 12.
PubMed 33189539Luetkens JA, Klein S, Traber F, Schmeel FC, Sprinkart AM, Kuetting DLR, Block W, Uschner FE, Schierwagen R, Hittatiya K, Kristiansen G, Gieseke J, Schild HH, Trebicka J, Kukuk GM. Quantification of Liver Fibrosis at T1 and T2 Mapping with Extracellular Volume Fraction MRI: Preclinical Results. Radiology. 2018 Sep;288(3):748-754. doi: 10.1148/radiol.2018180051. Epub 2018 Jun 26.
PubMed 29944086Syed M, Shah J, Montazeri SA, Grajo JR, Geller B, Toskich B. Analysis of dynamic hepatobiliary contrast-enhanced MRI signal intensity after Yttrium-90 radioembolization with glass microspheres for the treatment of hepatocellular carcinoma. Abdom Radiol (NY). 2021 May;46(5):2182-2187. doi: 10.1007/s00261-020-02855-2. Epub 2020 Nov 20.
PubMed 33216180Borhani AA, Elsayes KM, Catania R, Kambadakone A, Furlan A, Kierans AS, Kamath A, Harmath C, Horvat N, Humar A, Kielar AZ. Imaging Evaluation of Living Liver Donor Candidates: Techniques, Protocols, and Anatomy. Radiographics. 2021 Oct;41(6):1572-1591. doi: 10.1148/rg.2021210012.
PubMed 34597229Riaz A, Miller FH, Kulik LM, Nikolaidis P, Yaghmai V, Lewandowski RJ, Mulcahy MF, Ryu RK, Sato KT, Gupta R, Wang E, Baker T, Abecassis M, Benson AB 3rd, Nemcek AA Jr, Omary R, Salem R. Imaging response in the primary index lesion and clinical outcomes following transarterial locoregional therapy for hepatocellular carcinoma. JAMA. 2010 Mar 17;303(11):1062-9. doi: 10.1001/jama.2010.262.
PubMed 20233824Riaz A, Kulik L, Lewandowski RJ, Ryu RK, Giakoumis Spear G, Mulcahy MF, Abecassis M, Baker T, Gates V, Nayar R, Miller FH, Sato KT, Omary RA, Salem R. Radiologic-pathologic correlation of hepatocellular carcinoma treated with internal radiation using yttrium-90 microspheres. Hepatology. 2009 Apr;49(4):1185-93. doi: 10.1002/hep.22747.
PubMed 19133645Garin E, Tselikas L, Guiu B, Chalaye J, Edeline J, de Baere T, Assenat E, Tacher V, Robert C, Terroir-Cassou-Mounat M, Mariano-Goulart D, Amaddeo G, Palard X, Hollebecque A, Kafrouni M, Regnault H, Boudjema K, Grimaldi S, Fourcade M, Kobeiter H, Vibert E, Le Sourd S, Piron L, Sommacale D, Laffont S, Campillo-Gimenez B, Rolland Y; DOSISPHERE-01 Study Group. Personalised versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomised, multicentre, open-label phase 2 trial. Lancet Gastroenterol Hepatol. 2021 Jan;6(1):17-29. doi: 10.1016/S2468-1253(20)30290-9. Epub 2020 Nov 7.
PubMed 33166497Garin E, Rolland Y, Edeline J, Icard N, Lenoir L, Laffont S, Mesbah H, Breton M, Sulpice L, Boudjema K, Rohou T, Raoul JL, Clement B, Boucher E. Personalized dosimetry with intensification using 90Y-loaded glass microsphere radioembolization induces prolonged overall survival in hepatocellular carcinoma patients with portal vein thrombosis. J Nucl Med. 2015 Mar;56(3):339-46. doi: 10.2967/jnumed.114.145177. Epub 2015 Feb 12.
PubMed 25678490Mouli SK, Raiter S, Harris K, Mylarapu A, Burks M, Li W, Gordon AC, Khan A, Matsumoto M, Bailey KL, Pasciak AS, Manupipatpong S, Weiss CR, Casalino D, Miller FH, Gates VL, Hohlastos E, Lewandowski RJ, Kim DH, Dreher MR, Salem R. Yttrium-90 Radioembolization to the Prostate Gland: Proof of Concept in a Canine Model and Clinical Translation. J Vasc Interv Radiol. 2021 Aug;32(8):1103-1112.e12. doi: 10.1016/j.jvir.2021.01.282. Epub 2021 Apr 9.
PubMed 33839262Gates VL, Esmail AA, Marshall K, Spies S, Salem R. Internal pair production of 90Y permits hepatic localization of microspheres using routine PET: proof of concept. J Nucl Med. 2011 Jan;52(1):72-6. doi: 10.2967/jnumed.110.080986. Epub 2010 Dec 13.
PubMed 21149493Kao YH, Tan EH, Lim KY, Ng CE, Goh SW. Yttrium-90 internal pair production imaging using first generation PET/CT provides high-resolution images for qualitative diagnostic purposes. Br J Radiol. 2012 Jul;85(1015):1018-9. doi: 10.1259/bjr/33524085. Epub 2011 Oct 5.
PubMed 21976634Elschot M, Vermolen BJ, Lam MG, de Keizer B, van den Bosch MA, de Jong HW. Quantitative comparison of PET and Bremsstrahlung SPECT for imaging the in vivo yttrium-90 microsphere distribution after liver radioembolization. PLoS One. 2013;8(2):e55742. doi: 10.1371/journal.pone.0055742. Epub 2013 Feb 6.
PubMed 23405207Salem R, Johnson GE, Kim E, Riaz A, Bishay V, Boucher E, Fowers K, Lewandowski R, Padia SA. Yttrium-90 Radioembolization for the Treatment of Solitary, Unresectable HCC: The LEGACY Study. Hepatology. 2021 Nov;74(5):2342-2352. doi: 10.1002/hep.31819. Epub 2021 Jun 11.
PubMed 33739462Gabr A, Riaz A, Johnson GE, Kim E, Padia S, Lewandowski RJ, Salem R. Correlation of Y90-absorbed radiation dose to pathological necrosis in hepatocellular carcinoma: confirmatory multicenter analysis in 45 explants. Eur J Nucl Med Mol Imaging. 2021 Feb;48(2):580-583. doi: 10.1007/s00259-020-04976-8. Epub 2020 Aug 4.
PubMed 32749512Gupta AN, Serhal M, Gordon AC, Gabr A, Kalyan A, Kulik L, Sato KT, Riaz A, Hohlastos ES, Salem R, Lewandowski RJ. Radiation Segmentectomy and Modified Radiation Lobectomy for Unresectable Early-Stage Intrahepatic Cholangiocarcinoma. J Vasc Interv Radiol. 2025 Apr;36(4):650-659. doi: 10.1016/j.jvir.2024.12.016. Epub 2024 Dec 19.
PubMed 39709122
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Dose-Escalation Study to Define an Ablative Dose of Yttrium-90 Transarterial Radioembolization Using Advanced Dosimetry and Functional MRI (MARGIN Study)
- ClinicalTrials.gov ID
- NCT07586046
- Acronym / sponsor ID
- MARGIN / STU00224943
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- MARGIN, HCC, Y90, Liver Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Radiological Society of North America, Robert H. Lurie Cancer Center
- Study start
- 15 May 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 14 May 2026 (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 study is being done to help doctors improve how they treat liver tumors that cannot be removed by surgery or treated with standard ablation techniques. The researchers want to find out the best amount of radiation that needs to be delivered to completely destroy (or ablate) parts of the liver that have cancer.
Detailed description
Currently, doctors use Yttrium-90 (Y90) radiation segmentectomy, a treatment that delivers tiny radioactive beads into the blood vessels feeding the liver tumor. These beads give off radiation that helps kill the cancer cells from the inside, right where the tumor is located. This approach allows doctors to target the tumor very precisely, while keeping the rest of the liver as healthy as possible. However, the exact dose needed to fully ablate a tumor without damaging healthy liver tissue is not well established.
To answer this, the study team will use specialized imaging before and after treatment to evaluate how the radiation is distributed in the liver and how the liver responds over time. These imaging procedures include PET/CT or PET/MRI scans, which are standard medical imaging tests that are not considered experimental. During these scans, a small amount of a safe radioactive substance is injected into a participant's vein. This helps show where the Y90 beads are located in the participant's liver.
In a PET/CT scan, two types of imaging are performed during the same session. The PET scan detects signals from the radioactive substance and shows how the participant's liver is functioning at a molecular level. The CT scan, which uses x-rays to create detailed cross-sectional images of the body, provides a precise anatomical map that helps localize these functional signals. Together, they give a clear picture of both the structure and activity within the liver.
PET/MRI works similarly but uses magnetic fields and radio waves instead of x-rays. It combines the functional information from the PET scan with the highly detailed soft-tissue images from MRI, which can be especially useful in evaluating the liver. Both imaging techniques are done during a single visit, with the PET component typically performed at the same time as the CT or MRI, depending on which machine is used. Participants will also undergo a liver MRI with dual contrast using Eovist and extracellular gadolinium, another standard imaging procedure. MRI uses magnets and radio waves to take detailed pictures of the liver. Eovist is a special dye injected into a participant's vein during the scan that helps highlight liver tissue and shows how well different parts of the liver are functioning. Extracellular gadolinium is a more general contrast agent that enhances blood vessels and tissues, providing complementary information. This imaging helps the doctors confirm whether the tumor area was completely treated.
The goal is to determine the safest and most effective dose of radiation to fully treat cancer while preserving healthy liver tissue. This information may help doctors treat future patients more precisely and safely.
Yttrium-90 and the imaging methods used in this study, including PET/CT, PET/MRI, and dual contrast MRI, are FDA-approved.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators hypothesize that an optimal ablative dose exists between 200-500 Gy, with increasing ablation rates as dose increases, and that the threshold dose to achieve ablation differs between cirrhotic and non-cirrhotic livers. This hypothesis will be tested using voxel-based Y90 PET dosimetry and hepatobiliary MRI to assess dose-response relationships in both structural and functional imaging endpoints. Non-cirrhotic patients will begin at a dose of 200 Gy, while cirrhotic patients will begin at 300 Gy. Dose escalation will proceed in 100 Gy increments within each arm, with safety continuously evaluated by the Data Safety Monitoring Committee.
| Arm | Type | Receives |
|---|---|---|
| Cirrhotic | Active comparator | Other: Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheresCirrhotic patients will begin at 300 Gy. Dose escalation will proceed in 100 Gy increments within each arm, with safety continuously evaluated by the Data Safety Monitoring Committee |
| Non-cirrhotic | Active comparator | Other: Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheresNon-cirrhotic patients will begin at a dose of 200 Gy. Dose escalation will proceed in 100 Gy increments within each arm, with safety continuously evaluated by the Data Safety Monitoring Committee. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosis of hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver-dominant metastatic disease not amenable to surgical resection or ablation.
- Age ≥18 years.
- Child-Pugh class A or B liver function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate organ and bone marrow function as defined below:
Key exclusion criteria (9 listed)
- Extrahepatic metastases.
- Pregnant or breastfeeding individuals.
- Tumors requiring treatment of more than two Couinaud segments.
- Known hypersensitivity to gadolinium-based contrast agents.
- Contraindications to MRI (e.g., incompatible pacemakers, claustrophobia unresponsive to sedation).
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 |
|---|---|---|
| Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheresThe objective of this study is to define an optimal "ablative dose" range for Y90 Radiation Segmentectomy that achieves complete sectoral ablation detectable on dual contrast MRI and to determine whether this dose-response relationship differs between cirrhotic and non-cirrhotic patients. | Other | Cirrhotic, Non-cirrhotic |
Primary outcome
Ablative Dose Threshold for Y90 Radiation Segmentectomy
Time frame: From enrollment to the end of post-treatment Y90 12 month follow up visit
To prospectively define the "ablative dose" threshold for Y90 Radiation Segmentectomy (RS) using post-treatment PET dosimetry and hepatobiliary phase MRI
Impact of Cirrhosis on Ablative Dose Requirements
Time frame: From enrollment to enrollment to post-treatment Y-90 12 month follow-up visit
To determine whether cirrhotic patients require a higher threshold dose for ablation compared to non- cirrhotic patients
3 secondary outcomes
Correlation of Y90 Dose with Imaging Biomarkers
Time frame: Assessed at 1, 4-9, and 12 month follow up visits
Tumor Response and Time-to-Progression Assessment
Time frame: From enrollment to end of post-treatment Y-90 12 month follow up visit
Safety and Tolerability of Escalating Y90 Doses
Time frame: From enrollment to end of post-treatment Y90 12 month follow up visit
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 15 Sep 2026.
- Background: PubMed 33189539Gordon AC, Gates VL, White SB, Harris KR, Procissi D, Zhang Z, Li W, Samaan D, Nicolai JR, Mouli SK, Sato KT, Ryu RK, Omary RA, Salem R, Lewandowski RJ, Larson AC. Correlation and Agreement of Yttrium-90 Positron Emission Tomography/Computed Tomography with Ex Vivo Radioembolization Microsphere Deposition in the Rabbit VX2 Liver Tumor Model. J Vasc Interv Radiol. 2021 Jan;32(1):23-32.e1. doi: 10.1016/j.jvir.2020.09.016. Epub 2020 Nov 12.
- Background: PubMed 29944086Luetkens JA, Klein S, Traber F, Schmeel FC, Sprinkart AM, Kuetting DLR, Block W, Uschner FE, Schierwagen R, Hittatiya K, Kristiansen G, Gieseke J, Schild HH, Trebicka J, Kukuk GM. Quantification of Liver Fibrosis at T1 and T2 Mapping with Extracellular Volume Fraction MRI: Preclinical Results. Radiology. 2018 Sep;288(3):748-754. doi: 10.1148/radiol.2018180051. Epub 2018 Jun 26.
- Background: PubMed 33216180Syed M, Shah J, Montazeri SA, Grajo JR, Geller B, Toskich B. Analysis of dynamic hepatobiliary contrast-enhanced MRI signal intensity after Yttrium-90 radioembolization with glass microspheres for the treatment of hepatocellular carcinoma. Abdom Radiol (NY). 2021 May;46(5):2182-2187. doi: 10.1007/s00261-020-02855-2. Epub 2020 Nov 20.
- Background: PubMed 34597229Borhani AA, Elsayes KM, Catania R, Kambadakone A, Furlan A, Kierans AS, Kamath A, Harmath C, Horvat N, Humar A, Kielar AZ. Imaging Evaluation of Living Liver Donor Candidates: Techniques, Protocols, and Anatomy. Radiographics. 2021 Oct;41(6):1572-1591. doi: 10.1148/rg.2021210012.
- Background: PubMed 20233824Riaz A, Miller FH, Kulik LM, Nikolaidis P, Yaghmai V, Lewandowski RJ, Mulcahy MF, Ryu RK, Sato KT, Gupta R, Wang E, Baker T, Abecassis M, Benson AB 3rd, Nemcek AA Jr, Omary R, Salem R. Imaging response in the primary index lesion and clinical outcomes following transarterial locoregional therapy for hepatocellular carcinoma. JAMA. 2010 Mar 17;303(11):1062-9. doi: 10.1001/jama.2010.262.
- Background: PubMed 19133645Riaz A, Kulik L, Lewandowski RJ, Ryu RK, Giakoumis Spear G, Mulcahy MF, Abecassis M, Baker T, Gates V, Nayar R, Miller FH, Sato KT, Omary RA, Salem R. Radiologic-pathologic correlation of hepatocellular carcinoma treated with internal radiation using yttrium-90 microspheres. Hepatology. 2009 Apr;49(4):1185-93. doi: 10.1002/hep.22747.
- Background: PubMed 33166497Garin E, Tselikas L, Guiu B, Chalaye J, Edeline J, de Baere T, Assenat E, Tacher V, Robert C, Terroir-Cassou-Mounat M, Mariano-Goulart D, Amaddeo G, Palard X, Hollebecque A, Kafrouni M, Regnault H, Boudjema K, Grimaldi S, Fourcade M, Kobeiter H, Vibert E, Le Sourd S, Piron L, Sommacale D, Laffont S, Campillo-Gimenez B, Rolland Y; DOSISPHERE-01 Study Group. Personalised versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomised, multicentre, open-label phase 2 trial. Lancet Gastroenterol Hepatol. 2021 Jan;6(1):17-29. doi: 10.1016/S2468-1253(20)30290-9. Epub 2020 Nov 7.
- Background: PubMed 25678490Garin E, Rolland Y, Edeline J, Icard N, Lenoir L, Laffont S, Mesbah H, Breton M, Sulpice L, Boudjema K, Rohou T, Raoul JL, Clement B, Boucher E. Personalized dosimetry with intensification using 90Y-loaded glass microsphere radioembolization induces prolonged overall survival in hepatocellular carcinoma patients with portal vein thrombosis. J Nucl Med. 2015 Mar;56(3):339-46. doi: 10.2967/jnumed.114.145177. Epub 2015 Feb 12.
- Background: PubMed 33839262Mouli SK, Raiter S, Harris K, Mylarapu A, Burks M, Li W, Gordon AC, Khan A, Matsumoto M, Bailey KL, Pasciak AS, Manupipatpong S, Weiss CR, Casalino D, Miller FH, Gates VL, Hohlastos E, Lewandowski RJ, Kim DH, Dreher MR, Salem R. Yttrium-90 Radioembolization to the Prostate Gland: Proof of Concept in a Canine Model and Clinical Translation. J Vasc Interv Radiol. 2021 Aug;32(8):1103-1112.e12. doi: 10.1016/j.jvir.2021.01.282. Epub 2021 Apr 9.
- Background: PubMed 21149493Gates VL, Esmail AA, Marshall K, Spies S, Salem R. Internal pair production of 90Y permits hepatic localization of microspheres using routine PET: proof of concept. J Nucl Med. 2011 Jan;52(1):72-6. doi: 10.2967/jnumed.110.080986. Epub 2010 Dec 13.
- Background: PubMed 21976634Kao YH, Tan EH, Lim KY, Ng CE, Goh SW. Yttrium-90 internal pair production imaging using first generation PET/CT provides high-resolution images for qualitative diagnostic purposes. Br J Radiol. 2012 Jul;85(1015):1018-9. doi: 10.1259/bjr/33524085. Epub 2011 Oct 5.
- Background: PubMed 23405207Elschot M, Vermolen BJ, Lam MG, de Keizer B, van den Bosch MA, de Jong HW. Quantitative comparison of PET and Bremsstrahlung SPECT for imaging the in vivo yttrium-90 microsphere distribution after liver radioembolization. PLoS One. 2013;8(2):e55742. doi: 10.1371/journal.pone.0055742. Epub 2013 Feb 6.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yttrium-90 Radiation Segmentectomy (Y90 RS) using glass microspheres in people with HCC - Hepatocellular Carcinoma, run by Northwestern 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 14 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 15 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 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?
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?
Contact Andrew C Gordon, MD, PhD ((561)703-0134, andrew.gordon@nm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ablative Dose Threshold for Y90 Radiation Segmentectomy (time frame: From enrollment to the end of post-treatment Y90 12 month follow up visit). 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?
On the ClinicalTrials.gov record for NCT07586046, which also lists 22 linked publications.
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 15 Sep 2026.