Prostate AdenocarcinomaPhase 2NCT03933670
Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring Patients With Prostate Cancer on Active Surveillance
A Phase 2 study testing Hyperpolarized Carbon C 13 Pyruvate, Magnetic Resonance Spectroscopic Imaging and MRI Ultrasound Fusion Guided Biopsy in people with Prostate Adenocarcinoma and Prostate Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
This phase II trial studies the side how well hyperpolarized carbon C 13 pyruvate (HP C-13 pyruvate) magnetic resonance imaging (MRI) works in monitoring patients with prostate cancer on active surveillance who have not received treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Prostate Cancer
- What is being tested?
- Hyperpolarized Carbon C 13 Pyruvate, Magnetic Resonance Spectroscopic Imaging and MRI Ultrasound Fusion Guided Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2018to 30 Jun 2028
- Phase
- Phase 2
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has biopsy-proven adenocarcinoma of the prostate with low to intermediate risk disease by UCSF-CAPRA scoring at study entry.
- For Part 1: Patient planning to enroll or currently on active surveillance; For Part 2: Currently enrolled on active surveillance with planned fusion biopsy within 12 weeks following completion of baseline HP C-13 pyruvate/mpMRI on study.
- The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Absolute neutrophil count (ANC) >= 1000 cells/microliter (uL).
- Hemoglobin >= 9.0 gm/deciliter (dL).
Show all 11Show fewer
- Platelets >= 75,000 cells/uL.
- Estimated creatinine clearance* >= 50 milliliter (mL)/min by the Cockcroft Gault equation.
- Total bilirubin =< 1.5 x upper limit of normal (ULN) or if =< 3 x ULN if known/suspected Gilbert's
- Aspartate aminotransferase (AST) =< 1.5 x ULN.
- Alanine aminotransferase (ALT) =< 1.5 x ULN.
Who cannot join
- Patients without evidence of any prostate cancer on most recent prostate biopsy performed prior to study entry.
- Current or prior androgen deprivation therapy including luteinizing hormone-releasing hormone (LHRH) analogue or oral anti-androgen therapy. Previous use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least 28 days prior to baseline C-13 HP pyruvate MRI
- Prior radiation treatment of the prostate.
- Prostate biopsy performed within 14 days prior to baseline C-13 HP pyruvate MRI.
- Poorly controlled hypertension, with blood pressure at study entry > 160 mm Hg systolic or > 100 mmg Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted.
- Congestive heart failure with New York Heart Association (NYHA) status >= 2.
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 California, San Francisco
San Francisco, California, 94143
Louise Magat, (415) 502-1822, Louise.Magat@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: A Phase 2 Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) in Patients With Prostate Cancer on Active Surveillance
This phase II trial studies the side how well hyperpolarized carbon C 13 pyruvate (HP C-13 pyruvate) magnetic resonance imaging (MRI) works in monitoring patients with prostate cancer on active surveillance who have not received treatment. Diagnostic procedures, such as MRI, may help visualize HP C-13 pyruvate uptake and breakdown in tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- Optimize the imaging sequences that maximize signal-to-noise ratio (SNR) and intra-tumoral conversion of HP 13C pyruvate to lactate (kPL) and HP 13C pyruvate to glutamate (kPG) in regions of tumor versus (vs.) adjacent benign tissue as assessed by multi-parametric MRI (mpMRI) imaging characteristics. (Part 1) II. Determine the association between intra-tumoral kPL and kPG with Gleason grade determined during magnetic resonance (MR)/ultrasound (US)-guided fusion prostate biopsies obtained within 6 months following baseline HP C-13 pyruvate MR exam. (Part 2)
SECONDARY OBJECTIVES:
- Evaluate the intra-patient variability in intra-tumoral kPL and kPG with repeated dose studies.
II. Determine the association between peak intra-tumoral kPL observed on baseline imaging with serum prostate specific antigen (PSA).
III. Compare and contrast intra-tumoral kPL and kPG with prostate imaging reporting and data system (PI-RADS) version 2 and individual mpMRI parameters including apparent diffusion coefficient (ADC) on diffusion-weighted imaging.
IV. Describe the frequency of up-grading of tumor with MR/US-guided fusion biopsy obtained following baseline HP C-13 MR exam.
- Further characterize the safety profile of HP C-13 pyruvate injections.
EXPLORATORY OBJECTIVES:
- Correlate peak intra-tumoral kPL with results of gene expression profiling using DECIPHER assay.
II. Correlate peak intra-tumoral kPL and kPG with DECIPHER GRID tumor ribonucleic acid (RNA) expression of relevant components of the glycolytic pathway including lactate dehydrogenase (LDH), pyruvate dehydrogenase (PDH), aconitate hydratase (aconitase), myelocytomatosis oncogene (MYC), monocarboxylate transporter 4 (MCT4) (lactate transporter).
III. For patients who undergo optional follow-up HP C-13 pyruvate/MRI 6-15 months following baseline scan, determine the mean percent change from baseline in intra-tumoral kPL and kPG and whether the change from baseline is associated change in clinical risk assessment as determined by University of California, San Francisco (UCSF)-Cancer of the Prostate Risk Assessment (CAPRA) risk score.
OUTLINE:
Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than one minute, then undergo magnetic resonance spectroscopic imaging (MRSI) after 1-2 minutes. Within 15-60 minutes, patients may receive optional hyperpolarized carbon C 13 pyruvate and undergo MRSI. Patients also undergo MR/US fusion-guided prostate biopsy within 12 weeks following HP C-13 MRSI.
After completion of study, patients will be followed up periodically.
- Conditions
- Prostate Adenocarcinoma, Prostate Cancer
- Being tested
- Hyperpolarized Carbon C 13 Pyruvate, Magnetic Resonance Spectroscopic Imaging, MRI Ultrasound Fusion Guided Biopsy
- Keywords
- Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Carbon C 13 PyruvateDrug
Also called Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)
Given IV
Magnetic Resonance Spectroscopic ImagingProcedure or surgery
Also called Hydrogen-1 (1H)- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS
Undergo MRSI
MRI Ultrasound Fusion Guided BiopsyProcedure or surgery
Also called Fusion Biopsy, Fusion Guided Biopsy, Fusion-Guided Biopsy, MR Fusion Biopsy
Undergo MR/US fusion-guided prostate biopsy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (HP C-13 MRI) | Experimental | Patients receive hyperpolarized carbon C 13 pyruvate IV over less than one minute, then undergo MRSI after 1-2 minutes. Within 15-60 minutes, patients may receive optional hyperpolarized carbon C 13 pyruvate and undergo MRSI. Patients also undergo MR/US fusion-guided prostate biopsy within 12 weeks following HP C-13 MRSI. Receives: Drug: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Spectroscopic Imaging; Procedure: MRI Ultrasound Fusion Guided Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal-to-noise ratio (SNR) of hyperpolarized lactate
Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics.
Measured: At Baseline
Intra-tumoral C-pyruvate to lactate (kPL)
Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics
Measured: At Baseline
Intra-tumoral C-pyruvate to glutamate (kPG)
Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics
Measured: At Baseline
Association between intra-tumoral C-pyruvate to lactate (kPL) with Gleason grade
kPL will be compared with the pathologic Gleason grade determined using tissue from an MR/US-guided fusion prostate biopsy. Measured kPL will be compared by pathologic Gleason grade using an ANOVA model. If there is an overall difference, the Newman-Keuls post hoc test will be used to determine which tissue pairs differ.
Measured: Within 12 weeks following baseline HP C-13 pyruvate MR exam
Association between intra-tumoral C-pyruvate to glutamate (kPG) with Gleason grade
kPG will be compared with the pathologic Gleason grade determined using tissue from an MR/US-guided fusion prostate biopsy. Measured kPG will be compared by pathologic Gleason grade using an ANOVA model. If there is an overall difference, the Newman-Keuls post hoc test will be used to determine which tissue pairs differ.
Measured: Within 12 weeks following baseline HP C-13 pyruvate MR exam
Secondary outcomes (7)
Intra-patient variability in kPL
Intra-patient variability in the kPL will be summarized by the intraclass correlation and presented with a 90% confidence interval.
Measured: Up to 15 months
Intra-patient variability in kPG
Intra-patient variability in the kPG will be summarized by the intraclass correlation and presented with a 90% confidence interval.
Measured: Up to 15 months
Contrast between kPL and kPG in regions of tumor
The kPL and kPG will be contrasted in regions of tumor. Determined with prostate imaging reporting and data system (PI-RADS) version 2 classification score (1 through 5)
Measured: Up to 15 months
Comparison of kPL and kPG with apparent diffusion coefficient in region of tumor
The kPL and kPG will be compared with apparent diffusion coefficient in region of tumor. Determined by comparison to peak intra-tumoral apparent diffusion coefficient (ADC) value
Measured: Up to 15 months
Incidence of adverse events graded
According to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Measured: Up to 15 months
Association between peak intra-tumoral kPL observed on baseline imaging with serum PSA
Determine the association between peak intra-tumoral kPL observed on baseline imaging with serum PSA. The study cohort will be dichotomized by mean intra-tumoral kPL above and below the median and the mean serum PSA will be compared between the two dichotomized subgroups using Mann-Whitney test.
Measured: At Baseline
Describe frequency of up-grading of tumor
Describe the frequency of up-grading of tumor with MR/US-guided fusion biopsy obtained following baseline HP C-13 MR exam
Measured: Within 12 weeks following baseline HP C-13 pyruvate MR exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start18 Jul 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Principal investigator, Ivan de Kouchkovsky, MD, University of California, San Francisco
- Investigators
- Ivan de Kouchkovsky, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933670
- Sponsor's protocol ID
- 175516
- Other IDs
- R01CA211150, R01EB017449, U01CA232320-01A1, R01CA300053, NCI-2018-02195
- Status last verified
- May 2026
- First submitted
- 20 Feb 2019
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) in Patients With Prostate Cancer on Active Surveillance
- ClinicalTrials.gov ID
- NCT03933670
- Acronym / sponsor ID
- 175516
- Conditions
- Prostate Adenocarcinoma, Prostate Cancer
- Keywords
- Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 1 May 2019 (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 phase II trial studies the side how well hyperpolarized carbon C 13 pyruvate (HP C-13 pyruvate) magnetic resonance imaging (MRI) works in monitoring patients with prostate cancer on active surveillance who have not received treatment. Diagnostic procedures, such as MRI, may help visualize HP C-13 pyruvate uptake and breakdown in tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- Optimize the imaging sequences that maximize signal-to-noise ratio (SNR) and intra-tumoral conversion of HP 13C pyruvate to lactate (kPL) and HP 13C pyruvate to glutamate (kPG) in regions of tumor versus (vs.) adjacent benign tissue as assessed by multi-parametric MRI (mpMRI) imaging characteristics. (Part 1) II. Determine the association between intra-tumoral kPL and kPG with Gleason grade determined during magnetic resonance (MR)/ultrasound (US)-guided fusion prostate biopsies obtained within 6 months following baseline HP C-13 pyruvate MR exam. (Part 2)
SECONDARY OBJECTIVES:
- Evaluate the intra-patient variability in intra-tumoral kPL and kPG with repeated dose studies.
II. Determine the association between peak intra-tumoral kPL observed on baseline imaging with serum prostate specific antigen (PSA).
III. Compare and contrast intra-tumoral kPL and kPG with prostate imaging reporting and data system (PI-RADS) version 2 and individual mpMRI parameters including apparent diffusion coefficient (ADC) on diffusion-weighted imaging.
IV. Describe the frequency of up-grading of tumor with MR/US-guided fusion biopsy obtained following baseline HP C-13 MR exam.
- Further characterize the safety profile of HP C-13 pyruvate injections.
EXPLORATORY OBJECTIVES:
- Correlate peak intra-tumoral kPL with results of gene expression profiling using DECIPHER assay.
II. Correlate peak intra-tumoral kPL and kPG with DECIPHER GRID tumor ribonucleic acid (RNA) expression of relevant components of the glycolytic pathway including lactate dehydrogenase (LDH), pyruvate dehydrogenase (PDH), aconitate hydratase (aconitase), myelocytomatosis oncogene (MYC), monocarboxylate transporter 4 (MCT4) (lactate transporter).
III. For patients who undergo optional follow-up HP C-13 pyruvate/MRI 6-15 months following baseline scan, determine the mean percent change from baseline in intra-tumoral kPL and kPG and whether the change from baseline is associated change in clinical risk assessment as determined by University of California, San Francisco (UCSF)-Cancer of the Prostate Risk Assessment (CAPRA) risk score.
OUTLINE:
Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than one minute, then undergo magnetic resonance spectroscopic imaging (MRSI) after 1-2 minutes. Within 15-60 minutes, patients may receive optional hyperpolarized carbon C 13 pyruvate and undergo MRSI. Patients also undergo MR/US fusion-guided prostate biopsy within 12 weeks following HP C-13 MRSI.
After completion of study, patients will be followed up periodically.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (HP C-13 MRI) | Experimental | Drug: Hyperpolarized Carbon C 13 Pyruvate, Procedure: Magnetic Resonance Spectroscopic Imaging, Procedure: MRI Ultrasound Fusion Guided BiopsyPatients receive hyperpolarized carbon C 13 pyruvate IV over less than one minute, then undergo MRSI after 1-2 minutes. Within 15-60 minutes, patients may receive optional hyperpolarized carbon C 13 pyruvate and undergo MRSI. Patients also undergo MR/US fusion-guided prostate biopsy within 12 weeks following HP C-13 MRSI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The subject has biopsy-proven adenocarcinoma of the prostate with low to intermediate risk disease by UCSF-CAPRA scoring at study entry.
- For Part 1: Patient planning to enroll or currently on active surveillance; For Part 2: Currently enrolled on active surveillance with planned fusion biopsy within 12 weeks following completion of baseline HP C-13 pyruvate/mpMRI on study.
- The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Absolute neutrophil count (ANC) >= 1000 cells/microliter (uL).
Key exclusion criteria (6 listed)
- Patients without evidence of any prostate cancer on most recent prostate biopsy performed prior to study entry.
- Current or prior androgen deprivation therapy including luteinizing hormone-releasing hormone (LHRH) analogue or oral anti-androgen therapy. Previous use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least 28 days prior to baseline C-13 HP pyruvate MRI
- Prior radiation treatment of the prostate.
- Prostate biopsy performed within 14 days prior to baseline C-13 HP pyruvate MRI.
- Poorly controlled hypertension, with blood pressure at study entry > 160 mm Hg systolic or > 100 mmg Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted.
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 Carbon C 13 PyruvateAlso: Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)Given IV | Drug | Diagnostic (HP C-13 MRI) |
| Magnetic Resonance Spectroscopic ImagingAlso: Hydrogen-1 (1H)- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRSUndergo MRSI | Procedure or surgery | Diagnostic (HP C-13 MRI) |
| MRI Ultrasound Fusion Guided BiopsyAlso: Fusion Biopsy, Fusion Guided Biopsy, Fusion-Guided Biopsy, MR Fusion BiopsyUndergo MR/US fusion-guided prostate biopsy | Procedure or surgery | Diagnostic (HP C-13 MRI) |
Primary outcome
Signal-to-noise ratio (SNR) of hyperpolarized lactate
Time frame: At Baseline
Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics.
Intra-tumoral C-pyruvate to lactate (kPL)
Time frame: At Baseline
Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics
Intra-tumoral C-pyruvate to glutamate (kPG)
Time frame: At Baseline
Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics
Association between intra-tumoral C-pyruvate to lactate (kPL) with Gleason grade
Time frame: Within 12 weeks following baseline HP C-13 pyruvate MR exam
kPL will be compared with the pathologic Gleason grade determined using tissue from an MR/US-guided fusion prostate biopsy. Measured kPL will be compared by pathologic Gleason grade using an ANOVA model. If there is an overall difference, the Newman-Keuls post hoc test will be used to determine which tissue pairs differ.
Association between intra-tumoral C-pyruvate to glutamate (kPG) with Gleason grade
Time frame: Within 12 weeks following baseline HP C-13 pyruvate MR exam
kPG will be compared with the pathologic Gleason grade determined using tissue from an MR/US-guided fusion prostate biopsy. Measured kPG will be compared by pathologic Gleason grade using an ANOVA model. If there is an overall difference, the Newman-Keuls post hoc test will be used to determine which tissue pairs differ.
7 secondary outcomes
Intra-patient variability in kPL
Time frame: Up to 15 months
Intra-patient variability in kPG
Time frame: Up to 15 months
Contrast between kPL and kPG in regions of tumor
Time frame: Up to 15 months
Comparison of kPL and kPG with apparent diffusion coefficient in region of tumor
Time frame: Up to 15 months
Incidence of adverse events graded
Time frame: Up to 15 months
Association between peak intra-tumoral kPL observed on baseline imaging with serum PSA
Time frame: At Baseline
Describe frequency of up-grading of tumor
Time frame: Within 12 weeks following baseline HP C-13 pyruvate MR exam
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 18 May 2026.
- Individual participant dataSharing planned: No
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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.
Ivan de Kouchkovsky, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperpolarized Carbon C 13 Pyruvate, Magnetic Resonance Spectroscopic Imaging and MRI Ultrasound Fusion Guided Biopsy in people with Prostate Adenocarcinoma and Prostate Cancer, run by University of California, San Francisco 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 11 inclusion and 6 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 18 May 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Louise Magat ((415) 502-1822, Louise.Magat@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal-to-noise ratio (SNR) of hyperpolarized lactate (time frame: At Baseline). The study lists 5 primary outcomes in all. 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 18 May 2026.