Barcelona Clinic Liver Cancer (BCLC) Stage A, B or C HCCNCT07807475
DNP-MRSI of HCC Metabolism to Predict Therapeutic Response
An observational study of Barcelona Clinic Liver Cancer (BCLC) Stage A, B or C HCC and Hepatocellular Carcinoma (HCC), run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barcelona Clinic Liver Cancer (BCLC) Stage A, B or C HCC, Hepatocellular Carcinoma (HCC)
- What is being tested?
- Hyperpolarized 1-13C -Pyruvate
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2026to 15 Sep 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults age 18 and older. Patients with BCLC stage A, B or C HCC based on standard staging criteria.
Who may be able to join
- 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
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the duration of the study
Who cannot join
- 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
- 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
Show all 12Show fewer
- 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
- 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
- Decompensated cirrhosis (Child-Pugh C)
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Terence P. Gade, MD, PHD, 9175724113, TGade@pennmedicine.upenn.edu
Jelsia N. Cottone, 2157466788, jelsia.cottone@pennmedicine.upenn.edu
About this study
Official title: Dynamic Nuclear Polarization-MR Spectroscopic Imaging of Hepatocellular Carcinoma Metabolism to Predict Response Following Locoregional or Systemic Therapy
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.
Read the detailed description
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 intra-arterial infusion of a chemotherapeutic agent, (ii) trans-arterial radioembolization (TARE), an endovascular locoregional embolotherapy that involves hepatic artery embolization with intra-arterial infusion of a non-absorbable microspheres containing the radioactive material yttrium-90 (Y90) and (iii) microwave ablation, a percutaneous therapy that targets tumor cells using thermal energy. Together with systemic therapies (ST), these approaches represent the most commonly used treatments for HCC in the United States.
While these therapies have a proven survival benefit, local recurrence and progressive disease are common, and long-term survival rates are poor even following a complete radiographic response (49% over median follow-up of 72 months), due at least in part, to suboptimal measures of response. Conventional imaging approaches have been unsuccessful in providing representative measures of response that are essential for guiding locoregional and systemic therapies for HCC. These approaches apply established guidelines for measurements provided by anatomic imaging, such as tumor size, and were originally intended to allow a uniform response assessment following conventional chemotherapeutics. The general inability of these guidelines to characterize the response to LRT or systemic therapy underscores fundamental limitations in the applied imaging paradigms which fail to provide functional measures of the intended therapeutic effect or the associated tumor response. This challenge requires the development of new imaging paradigms applying knowledge of the underlying tumor biology to enable the detection of treatment refractory, viable tumor domains.
- Being tested
- Hyperpolarized 1-13C -Pyruvate
- Keywords
- HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 1-13C -PyruvateDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| TACE and MWA | Transarterial Chemoembolization
Microwave Ablation Receives: Drug: Hyperpolarized 1-13C -Pyruvate | |
| TARE | Transarterial Radioembolization Receives: Drug: Hyperpolarized 1-13C -Pyruvate | |
| Systemic Therapy | Systemic Therapy Receives: Drug: Hyperpolarized 1-13C -Pyruvate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective:
To estimate the accuracy of metabolic imaging using DNP-MRS imaging of hyperpolarized 1-13C-pyruvate uptake and metabolism for (i) predicting time to recurrence of HCC in patients following LRT or systemic therapy as determined by mRECIST criteria applied to standard-of- care (SOC) imaging.
Measured: 5 Years
Secondary outcomes (1)
Secondary Objective:
To measure alterations in metabolism of hyperpolarized 1-13C-pyruvate uptake and metabolism to 1-13C-lactate, 1- 13C-alanine and/or 13C-carbon dioxide/bicarbonate in enhancing and non- enhancing regions of tumor following LRT and ST.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start17 Sep 2026
- Primary completion15 Sep 2031 (estimated)
- Study completion15 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barcelona Clinic Liver Cancer (BCLC) Stage A, B or C HCCStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terence Gade, MD, PhD, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807475
- Sponsor's protocol ID
- UPCC22219
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Nuclear Polarization-MR Spectroscopic Imaging of Hepatocellular Carcinoma Metabolism to Predict Response Following Locoregional or Systemic Therapy
- ClinicalTrials.gov ID
- NCT07807475
- Acronym / sponsor ID
- UPCC22219
- Keywords
- HCC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- 15 Sep 2031 (estimated)
- Study completion
- 15 Sep 2034 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 intra-arterial infusion of a chemotherapeutic agent, (ii) trans-arterial radioembolization (TARE), an endovascular locoregional embolotherapy that involves hepatic artery embolization with intra-arterial infusion of a non-absorbable microspheres containing the radioactive material yttrium-90 (Y90) and (iii) microwave ablation, a percutaneous therapy that targets tumor cells using thermal energy. Together with systemic therapies (ST), these approaches represent the most commonly used treatments for HCC in the United States.
While these therapies have a proven survival benefit, local recurrence and progressive disease are common, and long-term survival rates are poor even following a complete radiographic response (49% over median follow-up of 72 months), due at least in part, to suboptimal measures of response. Conventional imaging approaches have been unsuccessful in providing representative measures of response that are essential for guiding locoregional and systemic therapies for HCC. These approaches apply established guidelines for measurements provided by anatomic imaging, such as tumor size, and were originally intended to allow a uniform response assessment following conventional chemotherapeutics. The general inability of these guidelines to characterize the response to LRT or systemic therapy underscores fundamental limitations in the applied imaging paradigms which fail to provide functional measures of the intended therapeutic effect or the associated tumor response. This challenge requires the development of new imaging paradigms applying knowledge of the underlying tumor biology to enable the detection of treatment refractory, viable tumor domains.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TACE and MWA | – | Drug: Hyperpolarized 1-13C -PyruvateTransarterial Chemoembolization Microwave Ablation |
| TARE | – | Drug: Hyperpolarized 1-13C -PyruvateTransarterial Radioembolization |
| Systemic Therapy | – | Drug: Hyperpolarized 1-13C -PyruvateSystemic Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults age 18 and older. Patients with BCLC stage A, B or C HCC based on standard staging criteria.
Key inclusion criteria (5 listed)
- 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
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the duration of the study
Key exclusion criteria (12 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized 1-13C -PyruvateThe 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). | Drug | Systemic Therapy, TACE and MWA, TARE |
Primary outcome
Primary Objective:
Time frame: 5 Years
To estimate the accuracy of metabolic imaging using DNP-MRS imaging of hyperpolarized 1-13C-pyruvate uptake and metabolism for (i) predicting time to recurrence of HCC in patients following LRT or systemic therapy as determined by mRECIST criteria applied to standard-of- care (SOC) imaging.
1 secondary outcome
Secondary Objective:
Time frame: 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barcelona Clinic Liver Cancer (BCLC) Stage A, B or C HCC and Hepatocellular Carcinoma (HCC), run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Terence Gade, MD, PhD (2155739756, TGade@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective: (time frame: 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.