RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: testing Hyperpolarized 1-13C -Pyruvate for Barcelona Clinic Liver Cancer (BCLC) Stage A, B or C HCC

This proposal describes a non-therapeutic diagnostic clinical trial to estimate the ability of DNP-MRS imaging of hyperpolarized 1-13C-pyruvate uptake and metabolism to predict response following LRT with TACE/TARE/Microwave Ablation or ST in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B or C HCC. The primary hypothesis is that intratumoral pyruvate, lactate, alanine and carbon dioxide/bicarbonate measured by DNP-MRSI correspond to cellular viability resulting from recurrent or progressive HCC following LRT or ST.

Official registry: https://clinicaltrials.gov/study/NCT07807475 · Abramson Cancer Center at Penn Medicine · enrollment listed as 232

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 232 people at Philadelphia. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Dynamic Nuclear Polarization-MR Spectroscopic Imaging of Hepatocellular Carcinoma Metabolism to Predict Response Following Locoregional or Systemic Therapy

Interventions: Hyperpolarized 1-13C -Pyruvate

Primary outcome (registry wording): Primary Objective:

Who it is for (from inclusion criteria)

Ages 18 Years to any
Male or female, aged ≥ 18 years
At least one HCC tumor meeting criteria for diagnosis of BCLC A, B or C HCC based on cross-sectional imaging as determined by a board-certified, sub-specialty trained radiologist
Baseline systolic blood pressure \>90 mmHg or \<180 mmHg
Willingness to comply with all study procedures and availability for the duration of the study

Who the registry excludes

Prior LRT or systemic cancer therapy to the target lesion
Contraindication to MRI including prior MRI contrast reaction
Metallic implant within the liver
Inability to tolerate imaging procedures in the opinion of an investigator or treating physician including but not limited to the inability to lie still in the magnet for 1 hour and/or cooperate with breath holding instructions
Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
Baseline systolic blood pressure \<90 mmHg or \>180 mmHg, or symptomatic orthostatic hypotension, measured within 1 hour prior to injection of hyperpolarized 1-13C-pyruvate
Congestive heart failure with New York Heart Association (NYHA) status ≥2

Public study contact (from the registry)

Terence Gade, MD, PhD

2155739756

TGade@pennmedicine.upenn.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

University of Pennsylvania — Philadelphia, Pennsylvania (recruiting)

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FAQ about this NCT record

Is NCT07807475 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07807475?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07807475?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary