DNP-MRSI to predict HCC treatment response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses non-therapeutic imaging to see if intratumoral metabolites measured by DNP-MRSI—pyruvate, lactate, alanine, and CO2/bicarbonate—correlate with viability after treatment. It also explores whether lactate-to-alanine ratios identify well- versus poorly perfused tumor regions on standard contrast-enhanced MRI. The goal is to help predict post-treatment outcomes by linking metabolic signals to tumor response. Eligible participants have HCC lesions in a suitable BCLC stage and will undergo DNP-MRSI imaging at defined time points, without receiving a new therapy as part of the trial. Lead sponsor is Abramson Cancer Center at Penn Medicine, with site at the University of Pennsylvania.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Terence Gade, MD, PhD
• Email: TGade@pennmedicine.upenn.edu
• Phone: 2155739756

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.