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AzTrials

BCLC Stage a Hepatocellular CarcinomaEarly Phase 1NCT05250895

BOLD MRI and FMISO PET for the Assessment of Hypoxic Tumor Microenvironment in Patients with Oligometastatic Liver Cancer Undergoing Yttirum-90 Selective Internal Radiation Therapy

A Early Phase 1 study testing 18F-Fluoromisonidazole, Biopsy and Dynamic Contrast-Enhanced Magnetic Resonance Imaging in people with BCLC Stage a Hepatocellular Carcinoma and BCLC Stage B Hepatocellular Carcinoma, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This early phase I trial evaluates the use of hypoxia (lack of oxygen) as a measure in determining the outcome of Y90 selective internal radiation therapy in patients with liver cancer that has spread to a limited number of sites (oligometastatic). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
18F-Fluoromisonidazole, Biopsy and Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
28 Apr 2022to 26 Feb 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

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

  • Age >= 18 years
  • Established HCC diagnosis, unilobar or bilobar disease
  • At least 1 tumor >= 3 cm
  • Oligometastatic disease
  • Barcelona Clinic Liver Cancer (BCLC) stage A, B or C
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
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  • Life expectancy > 12 weeks as determined by the Investigator
  • The effects of Y90 Radioembolization on the developing human fetus are unknown. For this reason, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
  • FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months

Who cannot join

  • Patients who are definite transplant candidates
  • Concurrent second malignancy outside of the liver
  • Infiltrative liver tumor
  • Previous liver-directed therapy to targeted tumors
  • BCLC stage D
  • Bilirubin > 2 mg/dL for lobar treatment and bilirubin > 3 mg/dL for segmental or bi-segmental Y90-SIRT
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  • Albumin < 3 g/dL
  • Projected lung dose of > 30 Gy in a single session to the liver after prospective treatment planning
  • Body mass index (BMI) > 40

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Molecular Imaging of the Hypoxic Tumor Microenvironment to Predict Response to Yttirum-90 Selective Internal Radiation Therapy in Hepatocellular Carcinoma- Pilot Study

This early phase I trial evaluates the use of hypoxia (lack of oxygen) as a measure in determining the outcome of Y90 selective internal radiation therapy in patients with liver cancer that has spread to a limited number of sites (oligometastatic). Radioembolization with Y90 is a minimally invasive procedure that combines embolization and radiation therapy to treat metastatic liver cancer. Tiny beads filled with radioactive isotope Y-90 are placed inside the blood vessel that provide blood supply to the tumor. This will block the blood flow to the tumor cells while providing a high radiation dose without harming healthy normal tissue.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To investigate the variability of hypoxia in hepatocellular carcinoma (HCC) as quantified by blood oxygen level-dependent (BOLD) magnetic resonance imaging (MRI) and dynamic 18F-Fluoromisonidazole (FMISO) positron emission tomography (PET).

SECONDARY OBJECTIVES:

  1. Investigate whether hypoxia, as quantified by BOLD MRI, dynamic FMISO PET, HIF-1alpha and VEGF expression, predicts HCC response to yttrium-90 (Y90) selective internal radiation therapy (SIRT).

II. Assess whether hypoxia quantification by BOLD MRI, dynamic FMISO, HIF-1alpha or VEGF expression individually or in combination more accurately predict the degree of HCC tumor response to Y90 SIRT.

III. Compare the tumor dose response threshold between hypoxic and non-hypoxic HCCs treated with Y90 SIRT.

OUTLINE:

Patients receive 18F-fluoromisonidazole intravenously (IV) and undergo PET and dynamic contrast enhanced (DCE) MRI within 30 days before beginning Y90 SIRT. Patients undergo Y90 SIRT per standard of care.

After completion of study intervention, patients are followed up at 90 days, and then every 12 weeks thereafter.

Being tested
18F-Fluoromisonidazole, Biopsy, Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Positron Emission Tomography
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-FluoromisonidazoleOther

    Also called 18F-MISO, 18F-Misonidazole, FMISO

    Given IV

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo biopsy

  • Dynamic Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery

    Also called DCE, DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI

    Undergo DCE MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo PET

Study groups in NCT05250895
Study groupRoleWhat they receive
Diagnostic (18F-fluoromisonidazole, PET, DCE MRI)ExperimentalPatients receive 18F-fluoromisonidazole IV and undergo PET and DCE MRI within 30 days before beginning Y90 SIRT. Patients undergo Y90 SIRT per standard of care.
Receives: Other: 18F-Fluoromisonidazole; Procedure: Biopsy; Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To investigate the variability of hypoxia in HCC at baseline as quantified by BOLD MRI

    Threshold <1.0 R2 tumor to normal ratio (no unit) as a cutoff for hypoxia

    Measured: From weeks 1-2 up to 1 year

  2. To investigate the variability of hypoxia in HCC at baseline as quantified by immunohistochemistry

    The staining intensity will be measured and scored with four scales: no staining=0, weak staining=1, moderate staining=2, and strong staining=3. The final staining score will be obtained by stained stumor area% x positive tumor cells % x staining intensity. The tumors will be then categorized as hypoxic (scores 8 to 16) vs. non-hypoxic (scores 0 to 7) (no units).

    Measured: From weeks 1-2 up to 1 year

Secondary outcomes (2)

  1. Determine whether hypoxia is predictor of response in HCC treated with Y90 SIRT

    Treatment Response Assessment using mRECIST

    Measured: From week 0 up to 1 year

  2. Treatment response

    Assessed using modified Response Evaluation Criteria in Solid Tumors.

    Measured: From week 0 Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2022
  2. Study start28 Apr 2022
  3. Primary completion26 Feb 2025
  4. Study completion26 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05250895
Sponsor's protocol ID
STUDY00002804
Other IDs
NCI-2021-09943, STUDY00002804, RAD5342-21, P30CA138292
Status last verified
Mar 2025
First submitted
22 Dec 2021
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 18F-Fluoromisonidazole, Biopsy and Dynamic Contrast-Enhanced Magnetic Resonance Imaging in people with BCLC Stage a Hepatocellular Carcinoma and BCLC Stage B Hepatocellular Carcinoma, run by Emory 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 10 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: finished, as of the sponsor's last update on 13 Mar 2025. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To investigate the variability of hypoxia in HCC at baseline as quantified by BOLD MRI (time frame: From weeks 1-2 up to 1 year). 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 NCT05250895.

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 13 Mar 2025.

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