DNP-MRSI of HCC Metabolism to Predict Therapeutic Response
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adults age 18 and older. Patients with BCLC stage A, B or C HCC based on standard staging criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Hyperpolarized 1-13C -Pyruvate
DrugThe 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).
Treatment groups
232 Participants
are divided into 3 treatment groupsGroup A: TACE and MWA1 intervention
Group B: TARE1 intervention
Group C: Systemic Therapy1 intervention
Trial outcomes
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 YearsSecondary 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 YearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: