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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Parenchymal Blood Volume (PBV) Imaging
  • Nitroglycerin
  • Medical Record Review

Treatment groups

50 Participants
are divided into 1 treatment group