Utilize Imaging to Assess Changes in Hepatocellular Carcinoma Perfusion as Potentiated by Intra-Arterial Nitroglycerin

NCT07682454 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 26323NCI-2026-04001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hepatocellular Carcinoma (HCC); Liver Cancer, Adult

Keywords

Parenchymal Blood Volume Imaging; Transarterial Chemoembolization; Intra-Arterial Nitroglycerin; Tumor Perfusion; TACE

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (1)

• Proportion of Participants with >= 50% increase in Tumor-to-Normal Ratio

  Day 1

Study Arms (1)

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.

Procedure: Parenchymal Blood Volume (PBV) Imaging; Drug: Nitroglycerin; Other: Medical Record Review

Interventions

Parenchymal Blood Volume (PBV) Imaging PROCEDURE

Undergo imaging

Also known as: PBV

Nitroglycerin Injection

Nitroglycerin DRUG

Given Intra-Arterially

Nitroglycerin Injection

Medical Record Review OTHER

Data will be collected from the participant medical records.

Also known as: Medical Chart Review

Nitroglycerin Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (2)

Zuckerberg San Francisco General Hospital (ZSFG)

San Francisco, California, 94110, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

X-Rays; Nitroglycerin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Nitro Compounds; Organic Chemicals

Study Officials

• Christopher Brunson, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Flores

CONTACT

415-514-6221; diana.flores@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: July 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)