Abramson Cancer Center at Penn Medicine
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.
Hepatocellular carcinoma (HCC) is the most rapidly increasing cause of cancer mortality in the United States (US)1. HCC is a notoriously chemo-resistant malignancy. Surgical resection or liver transplantation remain the therapies of choice; however, fewer than 20% of HCC patients are candidates for resection, and transplantation rates are limited both by a static donor pool and HCC progression which precludes eligibility. Locoregional therapies for HCC include (i) trans-arterial chemoembolization (TACE), an endovascular locoregional embolotherapy that involves hepatic artery embolization with…
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 a…
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).
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.