ClinicalTrials.gg
RecruitingNCT07807475Updated Nov 2, 2026

DNP-MRSI of HCC Metabolism to Predict Therapeutic Response

An observational study in Barcelona Clinic Liver Cancer (BCLC) Stage A, B or C HCC and Hepatocellular Carcinoma (HCC), sponsored by Abramson Cancer Center at Penn Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Abramson Cancer Center at Penn Medicine · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Nov 2, 2026Now RecruitingFirst site in United States+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
232
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Carcinoma, Hepatocellular by Abramson Cancer Center at Penn Medicine — 2 open to participants now, 4 under way, none of them phase 3. Carcinoma, Hepatocellular · Abramson Cancer Center at Penn Medicine.

Started
2026
the only one that year
Observational
Only one
of the 10
Registered
10th of 10
by date

Among the 10 studies in Carcinoma, Hepatocellular by Abramson Cancer Center at Penn Medicine, this one is the only one that started in 2026, is the only observational one, and was the 10th registered.

Carcinoma, Hepatocellular

3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.

Browse Carcinoma, Hepatocellular studies →

Open to participants now

2 of the 10 studies in Carcinoma, Hepatocellular by Abramson Cancer Center at Penn Medicine are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 736 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 30 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Carcinoma, Hepatocellular by Abramson Cancer Center at Penn Medicine, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

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

Keywords

  • HCC
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults age 18 and older. Patients with BCLC stage A, B or C HCC based on standard staging criteria.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form
  5. Willingness to comply with all study procedures and availability for the duration of the study

Exclusion criteria

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 , 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 , 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. 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 (NYHA) status ≥2
  9. A history of abnormalities, including , a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry
  10. Decompensated cirrhosis ( C)
  11. Estimated (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
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
232 participants (estimated)
Patient registry
No

Groups and cohorts

  • TACE and MWA

    Transarterial Chemoembolization Microwave Ablation

    Drug: Hyperpolarized 1-13C -Pyruvate

  • TARE

    Transarterial Radioembolization

    Drug: Hyperpolarized 1-13C -Pyruvate

  • Systemic Therapy

    Systemic Therapy

    Drug: Hyperpolarized 1-13C -Pyruvate

Interventions

  • DrugHyperpolarized 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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 5 Years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Sep 2031, 59 months after the start.

Of 302 non-industry observational studies under Carcinoma, Hepatocellular, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 114. This study's planned 59 months is close to that.

Counting every sponsor, half of 351 studies reached it within 51 months; a quarter within 32 and three quarters within 108.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2026
First posted
Sep 8, 2026
StartActual
Sep 17, 2026
Primary completionEst.
Sep 15, 2031
CompletionEst.
Sep 15, 2034
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Nov 2, 2026
Sites
1 site added — first site in United States
Show site
  • University of Pennsylvania · Philadelphia, United States
Nov 2, 2026
Start date
Sep 15, 2026→Sep 17, 2026 (actual)
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in United States
    Show site
    • University of Pennsylvania · Philadelphia, United States
    Start date Sep 15, 2026→Sep 17, 2026 (now actual)
    + 3 other changes: index terms, verification date and conditions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07807475
Responsible party
Terence Gade, MD, PhD (Mathew J Wilson Professor of Radiology Research II, Abramson Cancer Center at Penn Medicine) — Principal investigator
First posted
Sep 8, 2026
Start date
Sep 17, 2026
Primary completion
Sep 15, 2031 (estimated)
Completion
Sep 15, 2034 (estimated)
Last update
Nov 2, 2026

Study contacts

Terence Gade, MD, PhD
Contact
TGade@pennmedicine.upenn.edu
2155739756
Jelsia Cottone
Contact
jelsia.cottone@pennmedicine.upenn.edu
2157466788

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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