Metabolic Imaging for Ovarian Cancer

Overseen By Priya Bhosale, MD

Age: Any Age

Sex: Female

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Children, Pregnant, Cognitively impaired, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special imaging technique can detect ovarian cancer using a new contrast drug, Hyperpolarized 13-C-pyruvate. The researchers aim to determine if this drug, when used with an MRI machine, provides clearer images of the body's metabolism. The trial targets individuals with a family history of ovarian cancer, certain breast cancer histories, or specific genetic conditions. Participants may also join if they have some ovarian symptoms but aren't at high risk or are scheduled for surgery due to suspected ovarian cancer. This study seeks to find new ways to catch ovarian cancer early or monitor its progression. As a Phase 1 trial, the research focuses on understanding how this new treatment works in people, offering participants the opportunity to be among the first to experience this innovative imaging technique.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this MRSI technique is safe for use with hyperpolarized 13-C pyruvate?

Research has shown that hyperpolarized 13-C pyruvate, used in imaging, has promising safety data. Studies have found that people tolerate this contrast agent well. Specifically, safety data support its good safety profile, indicating it doesn’t cause significant harm or side effects. This is crucial because it enables doctors to observe how cancer cells use energy in real-time without causing discomfort or danger to patients. Although testing for this specific use is still in early stages, the current safety evidence appears encouraging for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for ovarian cancer focus on surgery or chemotherapy, targeting cancer cells directly. But Hyperpolarized 13-C-pyruvate works differently, offering a novel approach by enhancing metabolic imaging. This means it can provide a clearer picture of how cancer cells consume energy, potentially catching changes in tumors earlier and more accurately than traditional methods. Researchers are excited because it could lead to more personalized treatment plans, helping to tailor therapies to how a specific patient's cancer behaves.

What evidence suggests that this MRSI technique is effective for ovarian cancer?

Research has shown that hyperpolarized 13-C pyruvate, which participants in this trial will receive, is a promising method for viewing tumors in the body. Studies have found that this technique can distinguish between more aggressive and less aggressive tumors by analyzing their energy use. This capability might help doctors assess the seriousness of a tumor. In ovarian cancer, early results suggest that hyperpolarized 13-C pyruvate could indicate how well a tumor responds to treatment. So far, researchers have seen it as a useful way to observe tumor behavior in real time. ^{1 2 6 7 8}

Who Is on the Research Team?

Priya R. Bhosale

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults at high risk of ovarian cancer due to family history, personal history of early breast cancer, BRCA1/2 or mismatch repair gene mutations. It's also for those with suspected ovarian malignancy on imaging. Excluded are children, pregnant women, cognitively impaired adults, and prisoners.

Inclusion Criteria

I have at least two close relatives diagnosed with breast cancer before 50 or with ovarian cancer.

I had breast cancer before I turned 40.

I am going to MD Anderson for a pelvic ultrasound or have had one without finding a mass, or have a benign mass and am not at high risk for ovarian cancer.

Exclusion Criteria

Pregnant women will be excluded from participation

Cognitively impaired adults will be excluded from participation

Prisoners will be excluded from participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Assessment

Participants undergo metabolic imaging using hyperpolarized 13-C pyruvate MR to assess lactate production and correlate findings with metabolomics, immune profiles, and blood biomarkers.

1-2 weeks

Surgical Resection and Analysis

Participants undergo surgical resection, and imaging findings are correlated with pathology and genetic analysis.

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after imaging and surgical procedures.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized 13-C-pyruvate

Trial Overview The study tests if an MRI scan using a special contrast drug called hyperpolarized 13-C pyruvate can assess the aggressiveness of ovarian tumors. The '3T' scanner strength indicates a powerful MRI machine used in this process.

How Is the Trial Designed?

Group I: Hyperpolarized 13-C-pyruvate Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

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]

Hyperpolarised carbon-13 (13C)-MRI is a novel imaging technique that allows for dynamic imaging of tumor metabolism, particularly the conversion of [1-13C]pyruvate to [1-13C]lactate, which is relevant in cancer due to the Warburg effect.

Clinical studies have shown that hyperpolarised 13C-MRI can effectively differentiate between higher grade breast tumors and predict treatment responses to neoadjuvant chemotherapy by measuring early changes in 13C-label exchange.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarised 13C-MRI using 13C-pyruvate in breast cancer: A review. Arponen, O., Wodtke, P., Gallagher, FA., et al.[2023]

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]

The study introduces a new method, PHIP-SAH, for hyperpolarizing [1-13 C]pyruvate, which allows for real-time monitoring of metabolic processes in cancer research, particularly in glycolytic pathways.

Using this method, researchers successfully applied hyperpolarized [1-13 C]pyruvate to investigate glycolysis in two breast cancer cell lines, validating their findings with traditional biochemical assays, indicating its potential for broader cancer studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Studies of Tumor Cells Using [1-13 C] Pyruvate Hyperpolarized by Means of PHIP-Side Arm Hydrogenation. Cavallari, E., Carrera, C., Aime, S., et al.[2019]

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 13C-labelled cell substrates, like hyperpolarized pyruvate, could revolutionize anatomic imaging in oncology by providing new metabolic metrics for assessing treatment responses.

This imaging technique offers a more personalized approach to evaluating patients at different stages of cancer treatment, potentially improving clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic nuclear polarisation: The future of imaging in oncology? Serrao, EM., Brindle, KM.[2020]

The study successfully hyperpolarized [1,2-13C]pyruvate with approximately 7% polarization, allowing for enhanced monitoring of its conversion to lactate in cancer cells using a new pulse sequence called MINERVA.

This method enables simultaneous observation of different chemical reactions and the detection of reaction intermediates, such as 2-hydroperoxy-2-hydroxypropanoate, in real time, which could improve our understanding of metabolic processes in cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time Pyruvate Chemical Conversion Monitoring Enabled by PHIP. Stevanato, G., Ding, Y., Mamone, S., et al.[2023]

Hyperpolarized carbon 13 MRI (13C MRI) is a groundbreaking imaging technique that allows for real-time, noninvasive observation of tissue metabolism, particularly useful in cancer research.

This method has shown promise in clinical applications such as tumor grading, tailoring treatment based on metabolic profiles, and detecting early treatment responses by monitoring metabolic changes before structural alterations in tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized Carbon 13 MRI: Clinical Applications and Future Directions in Oncology. Deen, SS., Rooney, C., Shinozaki, A., et al.[2023]

In a study involving 17 canine cancer patients, hyperpolarized 13C Magnetic Resonance Spectroscopy (MRS) showed significant correlations between pyruvate-to-lactate conversion and 18F-FDG uptake specifically in sarcoma patients, suggesting a link between lactate generation and cancer metabolism.

The research indicates that the relationship between lactate production and 18F-FDG uptake varies by cancer type, with sarcoma patients exhibiting higher lactate generation relative to 18F-FDG uptake compared to carcinoma patients, which could enhance the understanding of cancer metabolism and improve diagnostic imaging techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined hyperpolarized 13C-pyruvate MRS and 18F-FDG PET (hyperPET) estimates of glycolysis in canine cancer patients. Hansen, AE., Gutte, H., Holst, P., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6490043/

Hyperpolarized 13C MRI: State of the Art and Future Directions Hyperpolarized carbon 13 MRI is an emerging molecular imaging technique that is actively undergoing clinical translation at multiple institutions.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10546364/

Hyperpolarized Carbon 13 MRI: Clinical Applications and ... Clinical results have now demonstrated that hyperpolarized [1-13C]pyruvate MRI findings can stratify tumors according to grade, with higher grade lesions ...

3. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.2017161772

In Vivo Assessment of Ovarian Tumor Response to ... The findings suggest that hyperpolarized 13C-pyruvate MR spectroscopy may serve as an early indicator of response to tyrosine kinase ( ...

4. cancer.gov cancer.gov/clinicaltrials/NCI-2023-03931

Hyperpolarized Carbon C13 Pyruvate with Magnetic ... This phase I trial evaluates the performance of an investigational contrast drug called hyperpolarized carbon C 13 pyruvate (HP 13C) used with magnetic ...

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

Hyperpolarized (13)C MRI: path to clinical translation in ... This white paper discusses prospects for advancing hyperpolarization technology to better understand cancer metabolism.

6. dctd.cancer.gov dctd.cancer.gov/drug-discovery-development/reagents-materials/imaging-ind-resources/documentation/13c-pyruvate-ib.pdf

Hyperpolarized Pyruvate (13C) Injection safety pharmacology data support adequate safety of Hyperpolarized Pyruvate (13C) Injection ... Hyperpolarized Carbon-13 MRI in Breast Cancer. Diagnostics ...

7. nature.com nature.com/articles/s41391-019-0180-z

Hyperpolarized 13 C-pyruvate MRI detects real-time ... HP 13 C-pyruvate MRI can detect real-time glycolytic metabolism within prostate cancer metastases, and can measure changes in quantitative k PL values ...

8. aacrjournals.org aacrjournals.org/cancerres/article/78/14/3755/631786/Metabolic-Imaging-of-the-Human-Brain-with

Metabolic Imaging of the Human Brain with Hyperpolarized 13 ... Hyperpolarized (HP) MRI using [1-13C] pyruvate is a novel method that can characterize energy metabolism in the human brain and brain tumors.