Recruiting

DNP-MRSI

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT07807475

Conditions

Barcelona Clinic Liver Cancer (BCLC) Stage A, B or C HCC

Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized 1-13C -Pyruvate

Study Details

Brief summary:

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. The secondary hypothesis is that lactate-to-alanine ratios measured by DNP-MRSI can distinguish well- vs. poorly perfused tumor regions as identified on contrast-enhanced MR imaging.

Conditions

Barcelona Clinic Liver Cancer (BCLC) Stage A, B or C HCC

Hepatocellular Carcinoma (HCC)

Study ID

NCT07807475

Start date

Sep 17, 2026

Status verified date

Oct, 2026

Completion date

Sep 15, 2034

Anticipated

Primary completion date

Sep 15, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female, aged ≥ 18 years
2. 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
3. Baseline systolic blood pressure >90 mmHg or <180 mmHg
4. Signed and dated informed consent form
5. Willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

1. Females who are pregnant or breast feeding at the time of screening will not be eligible for this study. Females who are breast feeding are excluded because breast feeding is not recommended during the therapies which are included in the inclusion criteria for this study. For females with childbearing potential, a serum or urine pregnancy test will be performed within 1 day prior to the injection of \[1-13C\]-pyruvate in women of child-bearing potential. A lack of childbearing potential is defined as A) ≥50 years old, without menstrual activity for >12 consecutive months, or B) Surgical sterilizations other than only tubal ligation. Females who do not meet the criteria defined in A, but have had tubal ligation, must still undergo pregnancy testing. Patient self-reporting the use of contraception, abstinence or same-sex partnership does not replace the need for pregnancy testing in women of childbearing potential
2. Prior LRT or systemic cancer therapy to the target lesion
3. Contraindication to MRI including prior MRI contrast reaction
4. Metallic implant within the liver
5. 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
6. 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
7. 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
8. Congestive heart failure with New York Heart Association (NYHA) status ≥2
9. A history of clinically significant EKG abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry
10. Decompensated cirrhosis (Child-Pugh C)
11. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 within 28 days prior to contrast-enhanced MRI, unless patient is already on chronic dialysis
12. Current use of high-dose beta-adrenergic antagonists (e.g., propranolol > 160 mg/day, metoprolol >200 mg/day, as these medications may impair compensatory tachycardia in response to pyruvate-induced vasodilation

Study Design

Enrollment

232 participants

Anticipated

Interventions and Outcome Measures

Arms

TACE and MWA

Transarterial Chemoembolization

Microwave Ablation

TARE

Transarterial Radioembolization

Systemic Therapy

Systemic Therapy

Interventions

Hyperpolarized 1-13C -Pyruvate

The 1-13C pyruvate dose for each DNP-MRSI session is approximately 0.43ml/kg of 250mM (approximate range for all studies is anticipated to be between 185-285 mM) of hyperpolarized 1-13C-pyruvate (11.9 mg/kg).

Primary outcome measure

  • Primary Objective: [ Time Frame: 5 Years ]

Central Contacts and Locations

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Terence P Gade, MD, PHD

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Keywords

  • HCC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.