NCT07807475 DNP-MRSI of HCC Metabolism to Predict Therapeutic Response

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 232 participants in total. It began in 2026-09-17 with a primary completion date of 2031-09-15.

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.

Eligibility Criteria

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

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