Benign Kidney NeoplasmPhase 2NCT04258462

Hyperpolarized 13C Pyruvate MRI Scan in Predicting Tumor Aggressiveness in Patients With Renal Tumors

A Phase 2 study testing Hyperpolarized Carbon C 13 Pyruvate, Magnetic Resonance Imaging and Hyperpolarized 13C,15N2-urea in people with Benign Kidney Neoplasm and Kidney Neoplasm, run by Zhen Wang, MD at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Benign Kidney Neoplasm, Kidney Neoplasm, Renal Cell Cancer
What is being tested?: Hyperpolarized Carbon C 13 Pyruvate, Magnetic Resonance Imaging and Hyperpolarized 13C,15N2-urea
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteUnited States
Study dates: 15 Jan 2019to 31 Oct 2026
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Renal tumor measuring 1 cm and greater in diameter. To minimize any potential partial volume effects in this pilot study, the investigators have limited the lower size range of the tumor to 1 cm. The investigators will include all renal tumor measuring 1 cm and greater in diameter in this first study to facilitate obtaining tumors of a range of histology and grade.
The participant is being considered by the treating physician to have any of the following management options: partial or radical nephrectomy, ablation, or active surveillance for his/her renal tumor.
The participant is able and willing to comply with study procedures and provide signed and dated informed consent.
The participant is willing to undergo standard of care abdominal MRI in connection with the study exam.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Who cannot join

Participants who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contra-indications to MR imaging, such as cardiac pacemakers or non-compatible intracranial vascular clips.
Any metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging of the abdomen.
Prior focal therapy (i.e. ablation) for the renal tumor.
Poorly controlled hypertension, with blood pressure at study entry >160/100. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
Congestive heart failure or New York Heart Association (NYHA) status >= 2.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, San Francisco
San Francisco, California, 94143

Other trials in United States

About this study

Official title: Hyperpolarized 13C Pyruvate Metabolic MRI to Predict Renal Tumor Aggressiveness

This feasibility study will evaluate how well hyperpolarized 13C pyruvate magnetic resonance imaging (MRI) scan works in predicting tumor aggressiveness in participants with renal tumors. Hyperpolarized 13C pyruvate is a non-radioactive substance with potential usage in the diagnostic imaging of tumors. Hyperpolarized 13C pyruvate MRI may help doctors determine non-invasively whether a kidney tumor is a benign tumor or cancer, and if cancer, how aggressive it is. This may help doctors and participants with renal tumors in the future to make better treatment decisions.

Read the detailed description

PRIMARY OBJECTIVES:

To investigate the association between HP 13C pyruvate-to-lactate conversion (peak lactate/pyruvate ratio, lactate /pyruvate AUC (area under the curve), the apparent rate constant (kPL) and renal tumor histology (benign renal tumors versus RCCs) and grade (low vs high grade in cases of RCCs).

SECONDARY OBJECTIVES:

To determine the reproducibility of HP 13C pyruvate MRI in participants who undergo an optional second HP 13C pyruvate MRI.
To investigate the association between HP 13 C pyruvate-to-lactate conversion and tumor growth rate in participants who are deemed clinically appropriate for active surveillance for their renal tumors.
To determine the safety of HP 13C pyruvate in renal tumor participants.

EXPLORATORY OBJECTIVES:

To investigate the association between HP markers (peak lactate/pyruvate, lactate /pyruvate AUC, kPL) and tissue-based markers including Lactate Dehydrogenase A (LDHA) expression and lactate dehydrogenase (LDH) activity, and Monocarboxylate transporter 4 (MCT4) expression on tumor tissues from surgical specimen or from biopsy.
To explore the correlation between HP 13C pyruvate-to-lactate conversion (peak lactate/pyruvate ratio, lactate/pyruvate AUC (area under the curve), the apparent rate constant kPL) and 13C urea tissue perfusion in the kidneys and renal tumors.

OUTLINE:

Participants receive HP 13C pyruvate intravenously (IV) or a combination of co-polarized 13C pyruvate and 13C, 15N2 Labeled urea (15N2) and then undergo MRI scan 1-2 minutes post injection

Participants may receive an optional second HP 13C pyruvate intravenously (IV) or a combination of hyperpolarized 13C pyruvate and 13C, 15N2 urea injection and undergo 13C pyruvate MRI scan 15 to 30 minutes following completion of the first scan during the same imaging session, or the participant can return for a separate visit within 1-2 weeks from the first MRI to receive the optional second scan.

After completion of study treatment, participants are followed up 30 minutes.

Conditions: Benign Kidney Neoplasm, Kidney Neoplasm, Renal Cell Cancer
Being tested: Hyperpolarized Carbon C 13 Pyruvate, Magnetic Resonance Imaging, Hyperpolarized 13C,15N2-urea
Medical subject headings: Kidney Neoplasms, Carcinoma, Renal Cell

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 ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan
Undergo MRI
Hyperpolarized 13C,15N2-ureaDrug
Also called HP 13C, 15N2
Given IV

Study groups in NCT04258462
Study group	Role	What they receive
Diagnostic (HP 13C pyruvate with MRI)	Experimental	Participants receive HP 13C pyruvate IV and then undergo 13C MRI scan 1-2 minutes post HP 13C pyruvate injection. Participants may receive an optional second HP 13C pyruvate injection and undergo 13C pyruvate MRI scan 15 to 30 minutes following completion of the first scan or at a return visit 1-2 weeks from the first HP C13 MRI Receives: Drug: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Imaging
Diagnostic (Combined (co-polarized) HP 13C pyruvate and 13C, 15N2 Urea with MRI)	Experimental	Participants receive HP 13C pyruvate and 13C 15N2 urea IV and then undergo an MRI scan 1-2 minutes post injection. Participants may receive an optional second HP 13C pyruvate with 13C 15N2 urea injection and undergo a second MRI scan 15 to 30 minutes following completion of the first scan or at a return visit 1-2 weeks from the first HP C13 MRI Receives: Drug: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Imaging; Drug: Hyperpolarized 13C,15N2-urea

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison between HP 13C pyruvate-to-lactate conversion, as measured by peak lactate/pyruvate ratio with tumor histology and grade.
Descriptive statistics (mean, median, standard deviation, distribution, etc) of the metabolism measures will be calculated. The investigators will use a tree-based cross-validated Classification \& Regression Trees (CART) model for predicting benign renal tumors vs. low grade renal cell carcinoma (RCC) vs. high grade RCCs based on the HP 13C pyruvate metabolic data
Measured: Up to 12 months
Comparison between HP 13C pyruvate-to-lactate conversion, as measured by the lactate /pyruvate area under curve (AUC) with tumor histology and grade.
Descriptive statistics (mean, median, standard deviation, distribution, etc) of the metabolism measures will be calculated. We will use a tree-based cross-validated Classification \& Regression Trees (CART) model for predicting benign renal tumors vs. low grade RCCs vs. high grade RCCs based on the HP 13C pyruvate metabolic data;
Measured: Up to 12 months
Comparison between HP 13C pyruvate-to-lactate conversion, as measured by the apparent rate of constant metabolic flux of HP 13C-pyruvate to lactate (kPL), with tumor histology and grade.
Descriptive statistics (mean, median, standard deviation, distribution, etc) of the metabolism measures will be calculated. The investigators will use a tree-based cross-validated Classification \& Regression Trees (CART) model for predicting benign renal tumors vs. low grade RCCs vs. high grade RCCs based on the HP 13C pyruvate metabolic data;
Measured: Up to 12 months

Secondary outcomes (3)

Estimate of intra-subject agreement for those with optional second scan
For participants who obtained an optional second HP 13 C pyruvate magnetic resonance imaging (MRI), intraclass correlation coefficient (ICC) will be used to estimate the intra-subject agreement. ICCs will be obtained from a one-way analysis of variance model based on 2 serial measurements per subject. The ICC ranges from 0 to 1. An ICC close to 1 indicates high similarity between values from the same group. An ICC close to zero means that values from the same group are not similar. The results will be presented with a 95% confidence interval.
Measured: Up to 12 months
Comparison of the HP 13C metabolism measures to change in tumor size
For participants who are in active surveillance for their renal tumors, MRI findings will be compared to tumor growth rate while on active surveillance. Correlations of HP 13C metabolism measures to change in tumor size on subsequent surveillance imaging studies will be performed using Pearson or rank correlation.
Measured: Up to 12 months
Incidence of treatment-related adverse events
Assessment of the occurrence of clinically significant changes in safety variables from baseline. Safety endpoints include monitoring for the occurrence of treatment-emergent AEs. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0.
Measured: 1 day, 30 minutes following hyperpolarized 13C pyruvate injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 201931 Oct 2026

First posted6 Feb 2020
Study start15 Jan 2019
Primary completion31 Oct 2026 (estimated)
Study completion31 Oct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Benign Kidney NeoplasmStudies of the same condition, open and under way.
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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04258462
Sponsor's protocol ID: 18525
Other IDs: NCI-2018-03692, R01CA249909
Status last verified: Feb 2026
First submitted: 2 Sep 2019
Last updated: 23 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Benign Kidney Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hyperpolarized 13C Pyruvate Metabolic MRI to Predict Renal Tumor Aggressiveness
ClinicalTrials.gov ID: NCT04258462
Acronym / sponsor ID: 18525
Conditions: Benign Kidney Neoplasm, Kidney Neoplasm, Renal Cell Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 54 participants (actual)
Lead sponsor: Zhen Wang, MDUniversity, hospital or other
Collaborators: American Cancer Society, Inc., National Cancer Institute (NCI)
Study start: 15 Jan 2019 (actual)
Primary completion: 31 Oct 2026 (estimated)
Study completion: 31 Oct 2026 (estimated)
First posted: 6 Feb 2020 (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.

Detailed description

PRIMARY OBJECTIVES:

To investigate the association between HP 13C pyruvate-to-lactate conversion (peak lactate/pyruvate ratio, lactate /pyruvate AUC (area under the curve), the apparent rate constant (kPL) and renal tumor histology (benign renal tumors versus RCCs) and grade (low vs high grade in cases of RCCs).

SECONDARY OBJECTIVES:

To determine the reproducibility of HP 13C pyruvate MRI in participants who undergo an optional second HP 13C pyruvate MRI.
To investigate the association between HP 13 C pyruvate-to-lactate conversion and tumor growth rate in participants who are deemed clinically appropriate for active surveillance for their renal tumors.
To determine the safety of HP 13C pyruvate in renal tumor participants.

EXPLORATORY OBJECTIVES:

To investigate the association between HP markers (peak lactate/pyruvate, lactate /pyruvate AUC, kPL) and tissue-based markers including Lactate Dehydrogenase A (LDHA) expression and lactate dehydrogenase (LDH) activity, and Monocarboxylate transporter 4 (MCT4) expression on tumor tissues from surgical specimen or from biopsy.
To explore the correlation between HP 13C pyruvate-to-lactate conversion (peak lactate/pyruvate ratio, lactate/pyruvate AUC (area under the curve), the apparent rate constant kPL) and 13C urea tissue perfusion in the kidneys and renal tumors.

OUTLINE:

Participants receive HP 13C pyruvate intravenously (IV) or a combination of co-polarized 13C pyruvate and 13C, 15N2 Labeled urea (15N2) and then undergo MRI scan 1-2 minutes post injection

After completion of study treatment, participants are followed up 30 minutes.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Diagnostic (HP 13C pyruvate with MRI)	Experimental	Drug: Hyperpolarized Carbon C 13 Pyruvate, Procedure: Magnetic Resonance ImagingParticipants receive HP 13C pyruvate IV and then undergo 13C MRI scan 1-2 minutes post HP 13C pyruvate injection. Participants may receive an optional second HP 13C pyruvate injection and undergo 13C pyruvate MRI scan 15 to 30 minutes following completion of the first scan or at a return visit 1-2 weeks from the first HP C13 MRI
Diagnostic (Combined (co-polarized) HP 13C pyruvate and 13C, 15N2 Urea with MRI)	Experimental	Drug: Hyperpolarized Carbon C 13 Pyruvate, Procedure: Magnetic Resonance Imaging, Drug: Hyperpolarized 13C,15N2-ureaParticipants receive HP 13C pyruvate and 13C 15N2 urea IV and then undergo an MRI scan 1-2 minutes post injection. Participants may receive an optional second HP 13C pyruvate with 13C 15N2 urea injection and undergo a second MRI scan 15 to 30 minutes following completion of the first scan or at a return visit 1-2 weeks from the first HP C13 MRI

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Renal tumor measuring 1 cm and greater in diameter. To minimize any potential partial volume effects in this pilot study, the investigators have limited the lower size range of the tumor to 1 cm. The investigators will include all renal tumor measuring 1 cm and greater in diameter in this first study to facilitate obtaining tumors of a range of histology and grade.
The participant is being considered by the treating physician to have any of the following management options: partial or radical nephrectomy, ablation, or active surveillance for his/her renal tumor.
The participant is able and willing to comply with study procedures and provide signed and dated informed consent.
The participant is willing to undergo standard of care abdominal MRI in connection with the study exam.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Key exclusion criteria (6 listed)

Participants who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contra-indications to MR imaging, such as cardiac pacemakers or non-compatible intracranial vascular clips.
Any metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging of the abdomen.
Prior focal therapy (i.e. ablation) for the renal tumor.
Poorly controlled hypertension, with blood pressure at study entry >160/100. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.

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 (Combined (co-polarized) HP 13C pyruvate and 13C, 15N2 Urea with MRI), Diagnostic (HP 13C pyruvate with MRI)
Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI ScanUndergo MRI	Procedure or surgery	Diagnostic (Combined (co-polarized) HP 13C pyruvate and 13C, 15N2 Urea with MRI), Diagnostic (HP 13C pyruvate with MRI)
Hyperpolarized 13C,15N2-ureaAlso: HP 13C, 15N2Given IV	Drug	Diagnostic (Combined (co-polarized) HP 13C pyruvate and 13C, 15N2 Urea with MRI)

Primary outcome

Comparison between HP 13C pyruvate-to-lactate conversion, as measured by peak lactate/pyruvate ratio with tumor histology and grade.
Time frame: Up to 12 months
Descriptive statistics (mean, median, standard deviation, distribution, etc) of the metabolism measures will be calculated. The investigators will use a tree-based cross-validated Classification \& Regression Trees (CART) model for predicting benign renal tumors vs. low grade renal cell carcinoma (RCC) vs. high grade RCCs based on the HP 13C pyruvate metabolic data
Comparison between HP 13C pyruvate-to-lactate conversion, as measured by the lactate /pyruvate area under curve (AUC) with tumor histology and grade.
Time frame: Up to 12 months
Descriptive statistics (mean, median, standard deviation, distribution, etc) of the metabolism measures will be calculated. We will use a tree-based cross-validated Classification \& Regression Trees (CART) model for predicting benign renal tumors vs. low grade RCCs vs. high grade RCCs based on the HP 13C pyruvate metabolic data;
Comparison between HP 13C pyruvate-to-lactate conversion, as measured by the apparent rate of constant metabolic flux of HP 13C-pyruvate to lactate (kPL), with tumor histology and grade.
Time frame: Up to 12 months
Descriptive statistics (mean, median, standard deviation, distribution, etc) of the metabolism measures will be calculated. The investigators will use a tree-based cross-validated Classification \& Regression Trees (CART) model for predicting benign renal tumors vs. low grade RCCs vs. high grade RCCs based on the HP 13C pyruvate metabolic data;

3 secondary outcomes

Estimate of intra-subject agreement for those with optional second scan
Time frame: Up to 12 months
Comparison of the HP 13C metabolism measures to change in tumor size
Time frame: Up to 12 months
Incidence of treatment-related adverse events
Time frame: 1 day, 30 minutes following hyperpolarized 13C pyruvate injection

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 23 Feb 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. This study is not recruiting at the moment.

Zhen Jane Wang, 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?

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 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: under way, not looking for participants, as of the sponsor's last update on 23 Feb 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison between HP 13C pyruvate-to-lactate conversion, as measured by peak lactate/pyruvate ratio with tumor histology and grade. (time frame: Up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04258462.

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 23 Feb 2026.