Hyperpolarized 13C Pyruvate MRI for Kidney Cancer

Overseen By Maya Aslam

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Zhen Wang, MD

Disqualifiers: Uncontrolled hypertension, Congestive heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of MRI scan using hyperpolarized 13C pyruvate to predict the aggressiveness of kidney tumors. The goal is to help doctors determine if a tumor is cancerous and assess its aggressiveness without surgery. Individuals with kidney tumors larger than 1 cm, considering options like surgery or monitoring, might be suitable for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in kidney tumor diagnostics.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have poorly controlled high blood pressure, you may need to adjust your medication to qualify for the study.

What prior data suggests that hyperpolarized 13C pyruvate MRI is safe for diagnostic use in kidney cancer?

Research has shown that hyperpolarized 13C pyruvate MRI is generally safe. Early human studies reported no side effects. This imaging technique uses a non-radioactive substance to help doctors assess the aggressiveness of a kidney tumor without surgery.

Studies have also found the combination of hyperpolarized 13C pyruvate and 13C 15N2 urea MRI to be safe. This method evaluates both tumor sugar usage and blood flow through the tissue. No safety concerns were reported with this combined approach.

Both imaging methods are currently in the middle stages of testing, having demonstrated safety in earlier trials. While still under evaluation, results so far suggest they are well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for kidney cancer rely on surgery, radiation, or systemic therapies like targeted drugs and immunotherapy. However, researchers are excited about using hyperpolarized 13C pyruvate with MRI because it offers a new way to visualize how kidney cancer is metabolizing substances in real-time. Unlike standard imaging techniques, this method provides a dynamic picture of tumor activity, potentially allowing for earlier and more precise detection of cancerous changes. Additionally, the combination of HP 13C pyruvate with 13C 15N2 urea in MRI could further enhance imaging by highlighting different metabolic pathways, giving doctors a clearer understanding of the tumor's behavior and possibly guiding more personalized treatment plans.

What evidence suggests that hyperpolarized 13C pyruvate MRI is effective for predicting tumor aggressiveness in kidney cancer?

Research has shown that a special MRI technique using hyperpolarized 13C pyruvate can help doctors determine if a kidney tumor is benign or cancerous, and even assess its aggressiveness. This imaging method has been successfully applied to other cancers, such as prostate and breast cancer. It reveals how tumors use energy, aiding in the distinction between healthy and cancerous tissues. In this trial, participants will receive either hyperpolarized 13C pyruvate alone or in combination with 13C 15N2 urea. Combining hyperpolarized 13C pyruvate with 13C 15N2 urea provides more information about the tumor's energy use and blood flow. This combination offers a clearer picture of tumor activity, helping doctors make better treatment decisions without invasive procedures. ^{1 2 3 6 7}

Who Is on the Research Team?

Zhen Jane Wang, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults with kidney tumors larger than 1 cm who can follow study procedures and give informed consent. They should be fit enough for potential kidney surgery or active monitoring, with a good performance status (able to carry out daily activities). People with metal implants affecting MRI quality, heart failure, uncontrolled high blood pressure, or those unable to undergo MRI are excluded.

Inclusion Criteria

Participant able and willing to comply with study procedures and provide signed and dated informed consent

My doctor is considering surgery, ablation, or monitoring for my kidney tumor.

My kidney tumor is at least 1 cm big.

Exclusion Criteria

My blood pressure is higher than 160/100 despite medication.

I have heart failure or my condition limits my physical activity.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HP 13C pyruvate intravenously and undergo MRI scan 1-2 minutes post injection. An optional second scan may occur 15 to 30 minutes later or within 1-2 weeks.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 minutes

Long-term monitoring

Participants' metabolic data and tumor growth are monitored for up to 12 months

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized 13C Pyruvate

Trial Overview The study tests if a special type of MRI scan using hyperpolarized 13C pyruvate can predict how aggressive kidney tumors are without invasive procedures. This non-radioactive imaging technique could help doctors and patients choose the best treatment by distinguishing between benign and cancerous tumors.

How Is the Trial Designed?

Group I: Diagnostic (HP 13C pyruvate with MRI) Experimental Treatment 2 Interventions

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

Group II: Diagnostic (Combined (co-polarized) HP 13C pyruvate and 13C, 15N2 Urea with MRI) Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

Zhen Wang, MD

Lead Sponsor

Trials

2

Recruited

110+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

Hyperpolarized carbon-13 (13C) MRI is a groundbreaking imaging technique that allows for real-time, noninvasive observation of metabolic processes in diseases like cancer and cardiovascular conditions, which were previously difficult to study.

The review highlights the promising clinical applications of HP [1-13C]pyruvate MRI, suggesting it could enhance our understanding of metabolism, improve disease diagnosis, and speed up treatment evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 13C MRI: State of the Art and Future Directions. Wang, ZJ., Ohliger, MA., Larson, PEZ., et al.[2020]

Hyperpolarized magnetic resonance imaging (HP-MRI) using (13)C-pyruvate is a promising tool for quantitatively assessing how solid tumors respond to radiotherapy and for monitoring potential toxicity in normal tissues.

This imaging technique can effectively predict responses related to metabolic changes in tumors, although there are still challenges to overcome for its successful use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Imaging as a Biomarker of Early Radiation Response in Tumors. Lai, SY., Fuller, CD., Bhattacharya, PK., et al.[2018]

Hyperpolarized 13C-MRI, which enhances the detection of tumor metabolism by 4-5 orders of magnitude, can track the metabolism of hyperpolarized [1-13C]pyruvate in cancer patients, providing insights into tumor activity and response to treatment.

Combining HP 13C-MRI with traditional 1H-MRI allows for detailed anatomical imaging and functional tumor analysis, potentially enabling early identification of patients who are not responding to therapies, although cost and technical challenges need to be addressed for broader clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized Carbon-13 MRI in Breast Cancer. Woitek, R., Brindle, KM.[2023]

Hyperpolarized 13C MRI, particularly using [1-13C]pyruvate, is a promising technique for measuring localized metabolism in various diseases, including cancers and organ disorders, and has seen significant advancements in human studies over the past decade.

The paper outlines essential practices for conducting successful HP 13C MRI studies, covering preparation, MRI setup, data acquisition, and analysis, while also highlighting current evidence gaps and limitations in the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Methods for Hyperpolarized [1-13C]pyruvate MRI Human Studies. Larson, PE., Bernard, JM., Bankson, JA., et al.[2023]

Hyperpolarized (HP) 13C MRI offers a promising new method for imaging kidney structure and function, particularly in assessing renal metabolism, which could improve the diagnosis and monitoring of kidney diseases.

Preclinical studies using various metabolic probes, such as [1-13C]pyruvate, indicate that HP 13C MRI has significant potential for evaluating conditions like kidney cancer and diabetic nephropathy, although further research is needed to transition these findings into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized Carbon (13C) MRI of the Kidneys: Basic Concept. von Morze, C., Reed, GD., Wang, ZJ., et al.[2022]

Hyperpolarized 13C-pyruvate MRI successfully detected high rates of glycolytic metabolism in metastatic prostate cancer, with specific kPL values indicating metabolic activity in bone and liver metastases.

The study demonstrated that HP 13C-pyruvate MRI can measure changes in metabolism over time, showing a decrease in kPL values in response to chemotherapy, suggesting its potential as a tool for monitoring treatment efficacy in advanced prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 13C-pyruvate MRI detects real-time metabolic flux in prostate cancer metastases to bone and liver: a clinical feasibility study. Chen, HY., Aggarwal, R., Bok, RA., et al.[2021]

Metabolic imaging using carbon-13 MRI (HP-13C-MRI) can effectively differentiate aggressive clear cell renal cell carcinoma (ccRCC) from less aggressive tumors, showing a strong correlation between the imaging results and tumor grade.

The study found that higher levels of the pyruvate transporter MCT1, which were linked to tumor aggressiveness, also predicted overall and disease-free survival in patients, suggesting that HP-13C-MRI could be a valuable non-invasive tool for assessing renal cancer aggressiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 13C-Pyruvate Metabolism as a Surrogate for Tumor Grade and Poor Outcome in Renal Cell Carcinoma-A Proof of Principle Study. Ursprung, S., Woitek, R., McLean, MA., et al.[2023]

Hyperpolarized 13C MRI has shown promise in providing unique metabolic insights into cancer, with a dose-ranging study confirming its safety and feasibility in patients with prostate cancer.

Ongoing research is exploring the use of hyperpolarized agents in various cancer types, and advancements in technology and collaboration among academia, industry, and government are essential for translating this imaging technique into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 13C MRI: Path to Clinical Translation in Oncology. Kurhanewicz, J., Vigneron, DB., Ardenkjaer-Larsen, JH., et al.[2023]

In a study using hyperpolarized 13C MRI on nine mice with partial unilateral ureteral obstruction (pUUO), significant changes in metabolic markers were observed, indicating a shift towards glycolytic metabolism in both kidneys after obstruction.

The obstructed kidney showed increased lactate to pyruvate ratios, hydronephrosis, fibrosis, and macrophage infiltration, highlighting the injury and inflammation specific to that kidney, while the unobstructed kidney remained unaffected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of renal metabolic response to partial ureteral obstruction with hyperpolarized 13 C MRI. Niles, DJ., Gordon, JW., Huang, G., et al.[2023]

Hyperpolarized 13C pyruvate MRI can noninvasively assess lactate production in renal tumors, which is linked to their aggressiveness, as shown in a study using mouse models of human renal cell carcinoma with varying LDHA and MCT4 expression.

The technique demonstrated that tumors with higher lactate production (A498) had greater pyruvate-to-lactate conversion and faster lactate export compared to less aggressive tumors, suggesting its potential to guide treatment decisions based on tumor behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-Invasive Assessment of Lactate Production and Compartmentalization in Renal Cell Carcinomas Using Hyperpolarized 13C Pyruvate MRI. Sriram, R., Gordon, J., Baligand, C., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8616838/

Clinical translation of hyperpolarized 13C pyruvate and urea ... The combined hyperpolarized (HP) 13 C pyruvate and urea MRI has provided a simultaneous assessment of glycolytic metabolism and tissue perfusion.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2319417024001057

Advancements, challenges, and future prospects in clinical ... Moreover, HP 13C pyruvate MRI offers the advantage of detecting metabolic changes that occur much earlier than changes in tumor size, helping to quickly ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04258462

Hyperpolarized 13C Pyruvate MRI Scan in Predicting ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9810116/

Development of Specialized Magnetic Resonance Acquisition ... We have developed a highly efficient method for imaging co-hyperpolarized 13 C pyruvate and urea for human studies.

5. nature.com nature.com/articles/s44303-025-00073-3

Translation of hyperpolarized [ 13 C, 15 N 2 ]urea MRI for ... This study developed a new approach to produce sterile, hyperpolarized [ 13 C, 15 N 2 ]urea as a novel molecular imaging probe and applied it for first-ever ...

6. ancora.ai ancora.ai/fr/details/NCT04258462

Hyperpolarized 13C Pyruvate MRI Scan in Predicting ... 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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1476558618304056

Hyperpolarized (13)C MRI: path to clinical translation in ... A dose-ranging study of HP [1-13C]pyruvate in patients with prostate cancer established safety and feasibility of this technique. Additional studies are ongoing ...