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Not yet recruitingNCT07916376BOLDMRIUpdated Nov 4, 2026

Characterizing Tumor Hypoxia With BOLD-MRI to Predict Y-90 Treatment Response

An interventional study of Blood oxygen level-dependent (BOLD) magnetic resonance imaging ( MRI) in Hepatocellular Carcinoma and Liver Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by UNC Lineberger Comprehensive Cancer Center · Not applicable, Interventional, and Diagnostic

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • 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
03

In context

Carcinoma, Hepatocellular

3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.

This study's planned enrollment of 12 is below the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 429 studies on the registry; 97 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 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.
  • (ECOG) performance status ≤2 ( Performance Status (KPS) ≥60%)
  • ≥6 months, as determined by the investigator.

Exclusion criteria

Exclusion Criteria:

All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation.

  • Definite liver transplant candidate
  • Concurrent secondary
  • Distant
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Hepatocellular carcinoma

    Patients with hepatocellular carcinoma (HCC) who are scheduled to receive Y-90 selective internal radiation therapy (SIRT),

    Diagnostic Test: Blood oxygen level-dependent (BOLD) magnetic resonance imaging ( MRI)

Interventions

  • Diagnostic testBlood 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Baseline

07

Study locations

1 site
08

References and documents

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07916376
Responsible party
Sponsor
First posted
Nov 4, 2026
Start date
Nov 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Markeela Lipscomb
Contact
markeela_lipscomb@med.unc.edu
919-972-7440
Kaila Brustkern
Contact
kaila_brustkern@med.unc.edu
984-974-3226
Alexander Villalobos, MD
principal investigator · UNC Lineberger Comprehensive Cancer Center
Bryan Harris, MD
principal investigator · UNC Lineberger Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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