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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

To learn if an MRSI can be performed on a 3T scanner using an investigational contrast drug called hyperpolarized 13-C pyruvate. 3T refers to the "strength" of the MRI machine.

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 data supports the effectiveness of the treatment Hyperpolarized 13-C-pyruvate for ovarian cancer?

Research shows that Hyperpolarized 13-C-pyruvate MRI can track cancer metabolism in real-time, which has been useful in other cancers like breast and prostate cancer. This imaging technique helps in understanding how tumors process energy, potentially allowing for better treatment decisions and early detection of treatment response. ^{1 2 3 4 5}

Is hyperpolarized 13C-pyruvate safe for use in humans?

The clinical feasibility of using hyperpolarized 13C-pyruvate MRI has been demonstrated in patients with breast cancer, suggesting it is generally safe for human use. However, the studies primarily focus on its application in imaging and do not provide detailed safety data. ^{1 6 7 8 9}

How does the treatment in the Metabolic Imaging for Ovarian Cancer trial differ from other treatments?

This treatment uses hyperpolarized 13C-pyruvate MRI, a novel imaging technique that allows real-time tracking of tumor metabolism, offering a more personalized approach to assessing treatment response compared to traditional imaging methods. ^{1 3 4 6 8}

Research Team

Priya R. Bhosale

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Hyperpolarized Carbon-13 MRI in Breast Cancer. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Combined hyperpolarized 13C-pyruvate MRS and 18F-FDG PET (hyperPET) estimates of glycolysis in canine cancer patients. [2019]

3. England 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Dynamic nuclear polarisation: The future of imaging in oncology? [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Hyperpolarized Carbon 13 MRI: Clinical Applications and Future Directions in Oncology. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Metabolic Studies of Tumor Cells Using [1-13 C] Pyruvate Hyperpolarized by Means of PHIP-Side Arm Hydrogenation. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Hyperpolarized 13C MRI: State of the Art and Future Directions. [2020]

8. Ireland pubmed.ncbi.nlm.nih.gov

Hyperpolarised 13C-MRI using 13C-pyruvate in breast cancer: A review. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Real-Time Pyruvate Chemical Conversion Monitoring Enabled by PHIP. [2023]