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.
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.
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.
Single group
Parenchymal Blood Volume (PBV) Imaging
Procedure/SurgeryUndergo imaging
Nitroglycerin
DrugGiven Intra-Arterially
Medical Record Review
Other interventionData will be collected from the participant medical records.
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.
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.
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