Hepatocellular CarcinomaBOLDMRINCT07916376
Characterizing Tumor Hypoxia With BOLD-MRI to Predict Y-90 Treatment Response
A study testing Blood oxygen level-dependent (BOLD) magnetic resonance imaging ( MRI) in people with Hepatocellular Carcinoma and Liver Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to find out whether a special type of magnetic resonance imaging ( MRI), called blood oxygen level-dependent (BOLD) MRI, can help measure how much oxygen is present in liver tumors. Tumors with low oxygen levels are described as being hypoxic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cancer
- What is being tested?
- Blood oxygen level-dependent (BOLD) magnetic resonance imaging ( MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to 31 Dec 2027
- Phase
- Interventional
- 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
- Subjects must meet all the inclusion criteria to participate in this study.
- Adults ≥ 18 years
- Liver mass(es) suspected of being HCC by imaging and are amenable to undergo percutaneous liver mass biopsy to confirm the HCC diagnosis, as determined by the institutional multidisciplinary tumor board.
- At least 1 tumor ≥ 2 cm and deemed to benefit from Y90 radioembolization by the institutional multidisciplinary tumor board.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky Performance Status (KPS) ≥60%)
- Life expectancy ≥6 months, as determined by the investigator.
Who cannot join
- All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Definite liver transplant candidate
- Concurrent secondary malignancy
- Distant metastasis
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
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Markeela Lipscomb, 919-972-7440, markeela_lipscomb@med.unc.edu
Kaila Brustkern, 984-974-3226, kaila_brustkern@med.unc.edu
About this study
Official title: Characterization of the Hypoxic Tumor Microenvironment With Blood Oxygen Level-Dependent Magnetic Resonance Imaging for the Prediction of Hepatocellular Carcinoma Response to Yttrium-90 Selective Internal Radiation Therapy
The purpose of this study is to find out whether a special type of magnetic resonance imaging ( MRI), called blood oxygen level-dependent (BOLD) MRI, can help measure how much oxygen is present in liver tumors. Tumors with low oxygen levels are described as being hypoxic.
Yttrium-90 (Y-90) is a type of radioactive material used to treat liver tumors, including hepatocellular carcinoma (HCC), a type of liver cancer. Y-90 is a form of radiation treatment delivered directly to liver tumors through tiny beads carried by blood vessels. These beads release radiation that damages and kills cancer cells while helping limit radiation exposure to surrounding healthy tissue. This treatment is also called Y-90 radioembolization or selective internal radiation therapy (SIRT).
Read the detailed description
The study will include 12 patients with liver tumors confirmed by biopsy to be hepatocellular carcinoma (HCC), a type of liver cancer, who are scheduled to receive Y-90 selective internal radiation therapy (SIRT), a treatment that delivers radiation directly to the tumor through blood vessels. Before treatment, participants will undergo a research MRI scan. A sample of their previously biopsied tumor tissue will also be examined in the laboratory to measure signs of low oxygen levels. The researchers will compare the MRI findings with the tissue results to determine whether BOLD MRI can reliably assess oxygen levels in liver tumors and may help predict how well the tumors respond to Y-90 treatment.
Standard-of-care Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE MRI) will be performed separately according to routine clinical practice before and after the Y90-SIRT procedure. BOLD MRI will be performed on a separate day after the pre-SIRT DCE MRI.
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Being tested
- Blood oxygen level-dependent (BOLD) magnetic resonance imaging ( MRI)
- Keywords
- magnetic resonance imaging ( MRI), blood oxygen level-dependent (BOLD) MRI, Yttrium-90 (Y-90), radioembolization, selective internal radiation therapy (SIRT), hypoxic, hypoxic tumor
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood oxygen level-dependent (BOLD) magnetic resonance imaging ( MRI)Diagnostic test
BOLD MRI will include 2D and 3D multi-echo gradient-echo sequences covering the liver, using body phased-array coils and breath-hold techniques. Imaging parameters may be adjusted as needed to optimize tumor visualization while maintaining data quality.
| Study group | Role | What they receive |
|---|---|---|
| Hepatocellular carcinoma | Experimental | Patients with hepatocellular carcinoma (HCC) who are scheduled to receive Y-90 selective internal radiation therapy (SIRT), Receives: Diagnostic Test: Blood oxygen level-dependent (BOLD) magnetic resonance imaging ( MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of successful novel blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI)
The number of successful novel blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) method for evaluating the level of tumor tissue hypoxia in patients with liver tumors.
Measured: Baseline
Secondary outcomes (1)
Hepatocellular carcinoma (HCC) hypoxia classification based on blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI)
Calculation of sensitivity, specificity, positive predictive value and negative predictive value of blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) based hepatocellular carcinoma (HCC) hypoxia classification.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startNov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Villalobos, MD, Principal investigator, UNC Lineberger Comprehensive Cancer CenterBryan Harris, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916376
- Sponsor's protocol ID
- LCCC2446
- Acronym
- BOLDMRI
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Hypoxic Tumor Microenvironment With Blood Oxygen Level-Dependent Magnetic Resonance Imaging for the Prediction of Hepatocellular Carcinoma Response to Yttrium-90 Selective Internal Radiation Therapy
- ClinicalTrials.gov ID
- NCT07916376
- Acronym / sponsor ID
- BOLDMRI / LCCC2446
- Conditions
- Hepatocellular Carcinoma, Liver Cancer
- Keywords
- magnetic resonance imaging ( MRI), blood oxygen level-dependent (BOLD) MRI, Yttrium-90 (Y-90), radioembolization, selective internal radiation therapy (SIRT), hypoxic, hypoxic tumor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Nov 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.
The purpose of this study is to find out whether a special type of magnetic resonance imaging ( MRI), called blood oxygen level-dependent (BOLD) MRI, can help measure how much oxygen is present in liver tumors. Tumors with low oxygen levels are described as being hypoxic.
Yttrium-90 (Y-90) is a type of radioactive material used to treat liver tumors, including hepatocellular carcinoma (HCC), a type of liver cancer. Y-90 is a form of radiation treatment delivered directly to liver tumors through tiny beads carried by blood vessels. These beads release radiation that damages and kills cancer cells while helping limit radiation exposure to surrounding healthy tissue. This treatment is also called Y-90 radioembolization or selective internal radiation therapy (SIRT).
Detailed description
The study will include 12 patients with liver tumors confirmed by biopsy to be hepatocellular carcinoma (HCC), a type of liver cancer, who are scheduled to receive Y-90 selective internal radiation therapy (SIRT), a treatment that delivers radiation directly to the tumor through blood vessels. Before treatment, participants will undergo a research MRI scan. A sample of their previously biopsied tumor tissue will also be examined in the laboratory to measure signs of low oxygen levels. The researchers will compare the MRI findings with the tissue results to determine whether BOLD MRI can reliably assess oxygen levels in liver tumors and may help predict how well the tumors respond to Y-90 treatment.
Standard-of-care Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE MRI) will be performed separately according to routine clinical practice before and after the Y90-SIRT procedure. BOLD MRI will be performed on a separate day after the pre-SIRT DCE MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatocellular carcinoma | Experimental | Diagnostic Test: Blood oxygen level-dependent (BOLD) magnetic resonance imaging ( MRI)Patients with hepatocellular carcinoma (HCC) who are scheduled to receive Y-90 selective internal radiation therapy (SIRT), |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must meet all the inclusion criteria to participate in this study.
- Adults ≥ 18 years
- Liver mass(es) suspected of being HCC by imaging and are amenable to undergo percutaneous liver mass biopsy to confirm the HCC diagnosis, as determined by the institutional multidisciplinary tumor board.
- At least 1 tumor ≥ 2 cm and deemed to benefit from Y90 radioembolization by the institutional multidisciplinary tumor board.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky Performance Status (KPS) ≥60%)
Key exclusion criteria (4 listed)
- All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Definite liver transplant candidate
- Concurrent secondary malignancy
- Distant metastasis
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 |
|---|---|---|
| Blood oxygen level-dependent (BOLD) magnetic resonance imaging ( MRI)BOLD MRI will include 2D and 3D multi-echo gradient-echo sequences covering the liver, using body phased-array coils and breath-hold techniques. Imaging parameters may be adjusted as needed to optimize tumor visualization while maintaining data quality. | Diagnostic test | Hepatocellular carcinoma |
Primary outcome
The number of successful novel blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI)
Time frame: Baseline
The number of successful novel blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) method for evaluating the level of tumor tissue hypoxia in patients with liver tumors.
1 secondary outcome
Hepatocellular carcinoma (HCC) hypoxia classification based on blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI)
Time frame: Baseline
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 4 Nov 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink 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.
Alexander Villalobos, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
Bryan Harris, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood oxygen level-dependent (BOLD) magnetic resonance imaging ( MRI) in people with Hepatocellular Carcinoma and Liver Cancer, run by UNC Lineberger Comprehensive 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Nov 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.
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 Markeela Lipscomb (919-972-7440, markeela_lipscomb@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of successful novel blood oxygen level dependent (BOLD) magnetic resonance imaging (MRI) (time frame: Baseline). 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 4 Nov 2026.