Hepatocellular Carcinoma (HCC)Phase 2NCT07682454
Utilize Imaging to Assess Changes in Hepatocellular Carcinoma Perfusion as Potentiated by Intra-Arterial Nitroglycerin
A Phase 2 study testing Parenchymal Blood Volume (PBV) Imaging, Nitroglycerin and Medical Record Review in people with Hepatocellular Carcinoma (HCC) and Liver Cancer, Adult, run by University of California, San Francisco at 2 sites in United States.
Trial summary
This is a single-arm, open-label, single-center, first-in-human feasibility study evaluating parenchymal blood volume (PBV) imaging as a tool to dynamically assess perfusional changes in hepatocellular carcinoma (HCC) potentiated by intra-arterial administration of nitroglycerin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Liver Cancer, Adult
- What is being tested?
- Parenchymal Blood Volume (PBV) Imaging, Nitroglycerin and Medical Record Review
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Dec 2026to 1 Jun 2030
- 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
- Participants must have radiographically documented, previously untreated LIRADS V liver lesions or biopsy-confirmed hepatocellular carcinoma (HCC), as determined by the ZSFG Liver Tumor Board.
- Lesions must be determined to be suitable for conventional trans-arterial chemoembolization (cTACE) based on multidisciplinary tumor board review.
- No prior locoregional therapy (e.g., TACE, Y-90) to the index lesion(s).
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky >70%)
- Demonstrates adequate organ function as defined below:
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- Absolute neutrophil count >=1,500/microliter (mcL).
- Platelets ≥100,000/microliter (mcL).
- Total bilirubin ≤ 3.0 milligrams per deciliter (mg/dL), unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits.
- Aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT) ≤3 X institutional upper limit of normal.
- Alanine aminotransferase (ALT) / serum glutamic-oxaloacetic transaminase (SGPT) ≤3 X institutional upper limit of normal
- Creatinine ≤ 1.5 x within institutional upper limit of normal or
- Creatinine clearance Glomerular filtration rate (GFR) >= 60 milliliters per minute (mL/min)/1.73 m2, calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 milliliters per minute (mL/min)/1.73 m2.
- Liver function: Child-Pugh score must be no higher than B5.
- Ability to understand and the willingness to sign a written informed consent document.
- Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- The female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception during the study and for 30 days after study intervention.
Who cannot join
- Multifocal disease (i.e., presence of more than one HCC lesion).
- Has received systemic anticancer therapies within 3 weeks of first dose, radiation within 2 weeks, antibody therapy within 4 weeks. Concomitant administration of LHRH analogues for prostate cancer and somatostatin analogues for neuroendocrine tumors are allowed as per standard of care.
- Has not recovered from adverse events due to prior anti-cancer therapy to ≤ grade 1 or baseline (other than alopecia).
- Is currently receiving any other therapeutic/investigational agents.
- Has participated in a study of an investigational product and received study treatment or used an investigational device within 3 weeks of the first use of an investigational product.
- Co-morbid disease or concurrent illness (e.g., cardiovascular disease, portal vein thrombosis).
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- Hypersensitivity to nitroglycerine or any of its excipients.
- Concomitant medications (contraindicated):
- Concurrent use of prescription phosphodiesterase inhibitors (e.g., sildenafil)
- Concurrent use of nitrate-containing medications.
- Concurrent use of vasoactive chemotherapeutic agents, such as bevacizumab (Avastin).
- Recent anti-cancer therapies:
- Systemic anticancer therapies within 3 weeks of the procedure.
- Radiation therapy within 2 weeks.
- Antibody-based therapy within 4 weeks.
- Use of investigational agents or devices within 3 weeks of the index procedure.
- Unresolved toxicities from prior cancer therapy, unless ≤ Grade 1 (excluding alopecia).
- Currently receiving any other therapeutic or investigational agents during the study period.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Zuckerberg San Francisco General Hospital (ZSFG)
San Francisco, California, 94110
Diana Flores, 415-514-6221, diana.flores@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
University of California, San Francisco
San Francisco, California, 94143
Diana Flores, 415-514-6221, diana.flores@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: Utilizing Parenchymal Blood Volume Imaging to Assess Changes in Hepatocellular Carcinoma Perfusion as Potentiated by Intra-Arterial Nitroglycerin
This is a single-arm, open-label, single-center, first-in-human feasibility study evaluating parenchymal blood volume (PBV) imaging as a tool to dynamically assess perfusional changes in hepatocellular carcinoma (HCC) potentiated by intra-arterial administration of nitroglycerin.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate in vivo, parenchymal blood volume imaging's ability to dynamically assess blood flow to hepatocellular carcinoma.
SECONDARY OBJECTIVES:
- Quantitative measurement of tumor perfusion after intra-arterial injection of nitroglycerin using parenchymal blood volume imaging.
OUTLINE:
Participants will undergo parenchymal blood volume (PBV) imaging before and after intra-arterial nitroglycerin injection during their standard transarterial chemoembolization (TACE) treatment. Participants will be followed on days 3, 7, 30, and 90 after the procedure.
- Being tested
- Parenchymal Blood Volume (PBV) Imaging, Nitroglycerin, Medical Record Review
- Keywords
- Parenchymal Blood Volume Imaging, Transarterial Chemoembolization, Intra-Arterial Nitroglycerin, Tumor Perfusion, TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenchymal Blood Volume (PBV) ImagingProcedure or surgery
Also called PBV
Undergo imaging
NitroglycerinDrug
Given Intra-Arterially
Medical Record ReviewOther
Also called Medical Chart Review
Data will be collected from the participant medical records.
| Study group | Role | What they receive |
|---|---|---|
| Nitroglycerin Injection | Experimental | Participants with confirmed hepatocellular carcinoma (HCC) will undergo parenchymal blood volume (PBV) imaging before and after intra-arterial nitroglycerin injection during standard transarterial chemoembolization (TACE) treatment. Nitroglycerin doses ranging from 200-300 micrograms will be administered based on patient body mass index (BMI) and interventional radiology standards. Participants will be followed either in person or via telehealth on days 3, 7, 30, and 90 for safety and post-procedural assessment, until withdrawal from the study or death, whichever occurs first. Receives: Procedure: Parenchymal Blood Volume (PBV) Imaging; Drug: Nitroglycerin; Other: Medical Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with >= 30% increase in Tumoral Blood Volume
Proportion of participants who demonstrate an increase in tumoral blood volume of at least 30% following intra-arterial nitroglycerin administration compared with pre-nitroglycerin baseline along with Bonferroni-corrected confidence intervals will be reported.
Measured: Day 1
Secondary outcomes (1)
Proportion of Participants with >= 50% increase in Tumor-to-Normal Ratio
Proportion of participants demonstrating at least a 50% increase in the tumor-to-normal ratio on parenchymal blood volume imaging following intra-arterial nitroglycerin administration compared with pre-nitroglycerin baseline along with Bonferroni-corrected confidence intervals will be reported.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start15 Dec 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Brunson, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682454
- Sponsor's protocol ID
- 26323
- Other IDs
- NCI-2026-04001
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Parenchymal Blood Volume Imaging to Assess Changes in Hepatocellular Carcinoma Perfusion as Potentiated by Intra-Arterial Nitroglycerin
- ClinicalTrials.gov ID
- NCT07682454
- Acronym / sponsor ID
- 26323
- Keywords
- Parenchymal Blood Volume Imaging, Transarterial Chemoembolization, Intra-Arterial Nitroglycerin, Tumor Perfusion, TACE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 2 Jul 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 is a single-arm, open-label, single-center, first-in-human feasibility study evaluating parenchymal blood volume (PBV) imaging as a tool to dynamically assess perfusional changes in hepatocellular carcinoma (HCC) potentiated by intra-arterial administration of nitroglycerin.
Detailed description
PRIMARY OBJECTIVES:
- Evaluate in vivo, parenchymal blood volume imaging's ability to dynamically assess blood flow to hepatocellular carcinoma.
SECONDARY OBJECTIVES:
- Quantitative measurement of tumor perfusion after intra-arterial injection of nitroglycerin using parenchymal blood volume imaging.
OUTLINE:
Participants will undergo parenchymal blood volume (PBV) imaging before and after intra-arterial nitroglycerin injection during their standard transarterial chemoembolization (TACE) treatment. Participants will be followed on days 3, 7, 30, and 90 after the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nitroglycerin Injection | Experimental | Procedure: Parenchymal Blood Volume (PBV) Imaging, Drug: Nitroglycerin, Other: Medical Record ReviewParticipants with confirmed hepatocellular carcinoma (HCC) will undergo parenchymal blood volume (PBV) imaging before and after intra-arterial nitroglycerin injection during standard transarterial chemoembolization (TACE) treatment. Nitroglycerin doses ranging from 200-300 micrograms will be administered based on patient body mass index (BMI) and interventional radiology standards. Participants will be followed either in person or via telehealth on days 3, 7, 30, and 90 for safety and post-procedural assessment, until withdrawal from the study or death, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Participants must have radiographically documented, previously untreated LIRADS V liver lesions or biopsy-confirmed hepatocellular carcinoma (HCC), as determined by the ZSFG Liver Tumor Board.
- Lesions must be determined to be suitable for conventional trans-arterial chemoembolization (cTACE) based on multidisciplinary tumor board review.
- No prior locoregional therapy (e.g., TACE, Y-90) to the index lesion(s).
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky >70%)
Key exclusion criteria (18 listed)
- Multifocal disease (i.e., presence of more than one HCC lesion).
- Has received systemic anticancer therapies within 3 weeks of first dose, radiation within 2 weeks, antibody therapy within 4 weeks. Concomitant administration of LHRH analogues for prostate cancer and somatostatin analogues for neuroendocrine tumors are allowed as per standard of care.
- Has not recovered from adverse events due to prior anti-cancer therapy to ≤ grade 1 or baseline (other than alopecia).
- Is currently receiving any other therapeutic/investigational agents.
- Has participated in a study of an investigational product and received study treatment or used an investigational device within 3 weeks of the first use of an investigational product.
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 |
|---|---|---|
| Parenchymal Blood Volume (PBV) ImagingAlso: PBVUndergo imaging | Procedure or surgery | Nitroglycerin Injection |
| NitroglycerinGiven Intra-Arterially | Drug | Nitroglycerin Injection |
| Medical Record ReviewAlso: Medical Chart ReviewData will be collected from the participant medical records. | Other | Nitroglycerin Injection |
Primary outcome
Proportion of Participants with >= 30% increase in Tumoral Blood Volume
Time frame: Day 1
Proportion of participants who demonstrate an increase in tumoral blood volume of at least 30% following intra-arterial nitroglycerin administration compared with pre-nitroglycerin baseline along with Bonferroni-corrected confidence intervals will be reported.
1 secondary outcome
Proportion of Participants with >= 50% increase in Tumor-to-Normal Ratio
Time frame: Day 1
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 13 Oct 2026.
- 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.
Christopher Brunson, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Parenchymal Blood Volume (PBV) Imaging, Nitroglycerin and Medical Record Review in people with Hepatocellular Carcinoma (HCC) and Liver Cancer, Adult, run by University of California, San Francisco at 2 sites 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 17 inclusion and 18 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Diana Flores (415-514-6221, diana.flores@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with >= 30% increase in Tumoral Blood Volume (time frame: Day 1). 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 13 Oct 2026.