hpMRI Scan for Thyroid Cancer

Overseen By Stephen Y Lai

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Severe claustrophobia, Implants, Cardiac arrhythmia, Allergy, eGFR < 30, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 week

42 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial investigates whether hyperpolarized magnetic resonance imaging (hpMRI) can predict treatment response in patients with thyroid cancer and other malignancies of the head and neck undergoing radiation therapy and/or receiving systemic therapy before surgery. An hpMRI is like a standard MRI but involves the use of an imaging contrast agent called hyperpolarized 13-C-pyruvate. Diagnostic procedures, such as hpMRI, may predict a patient's response to treatment and may help plan the best treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Hyperpolarized Carbon C 13 Pyruvate for thyroid cancer?

Research shows that Hyperpolarized Carbon 13 MRI, which uses Hyperpolarized Carbon C 13 Pyruvate, is effective in imaging cancer metabolism and detecting early treatment responses in various cancers like breast and prostate cancer. This suggests potential for similar effectiveness in thyroid cancer by providing detailed metabolic information and early detection of treatment response. ^{1 2 3 4 5}

Is Hyperpolarized Carbon C 13 Pyruvate safe for use in humans?

A study involving Hyperpolarized Carbon C 13 Pyruvate in patients with prostate cancer found it to be safe and feasible, and additional studies are ongoing in various cancers, suggesting it is generally safe for human use. ^{1 3 4 5 6}

How does the hpMRI scan treatment for thyroid cancer differ from other treatments?

The hpMRI scan for thyroid cancer is unique because it uses hyperpolarized carbon-13 MRI to provide real-time images of tumor metabolism, which can help in early detection and treatment response monitoring. This approach is different from traditional imaging methods as it offers enhanced sensitivity and detailed metabolic information, potentially allowing for more personalized treatment strategies. ^{1 2 4 5 7}

Research Team

Stephen Y. Lai

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for individuals with thyroid cancer or other head and neck malignancies who are undergoing radiation or systemic therapy before surgery. Participants must understand the study's experimental nature and give informed consent. It excludes those with severe claustrophobia, certain implants, cardiac arrhythmia, allergy to Gadavist contrast, eGFR < 30, or women who are pregnant/breastfeeding.

Inclusion Criteria

Be willing and able to provide informed consent

Be informed of the investigational nature of this study

You have been diagnosed with thyroid cancer or other cancers in the head and neck that need treatment.

Exclusion Criteria

If female, be pregnant or breast feeding at time of consent

You have experienced strong fear in small, enclosed spaces in the past.

You have implants that can be activated by electricity, magnets, or movement, which would prevent you from having a magnetic resonance imaging (MRI) scan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Patients undergo hpMRI over 30 minutes at baseline, receiving hyperpolarized 13-C-pyruvate IV

1 day

1 visit (in-person)

Treatment

Patients receive radiation therapy and/or systemic therapy, with hpMRI at 1 week after initiation

1 week

1 visit (in-person)

Follow-up

Participants are monitored for early metabolic changes in response to therapy

1 day

1 visit (in-person)

Treatment Details

Interventions

• Hyperpolarized Carbon C 13 Pyruvate

Trial Overview The trial is testing if a special type of MRI scan using hyperpolarized carbon C 13 pyruvate (hpMRI) can predict how well patients respond to treatment for thyroid cancer and related conditions. The hpMRI may help in planning more effective treatments by providing early feedback on the success of ongoing therapies.

Participant Groups

Group I: Arm II (Thyroid Cancer Patient and other malignancies of the head and neck hpMRI) Experimental Treatment 2 Interventions

Patients with thyroid cancer and other malignancies of the head and neck undergo hpMRI over 30 minutes at baseline, and at 1 week after the initiation of treatment. During the scan, patients also receive hyperpolarized 13-C-pyruvate IV over 30 seconds and may receive a standard MRI contrast agent at the discretion of the treating physician.

Group II: Arm I ( Health Volunteer MRI) Active Control 1 Intervention

Healthy volunteers undergo MRI over 30 minutes.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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]

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]

Hyperpolarized (HP) (13)C labeled compounds, particularly HP 1-(13)C pyruvate, are effective MR contrast agents that allow for real-time investigation of metabolic pathways in vivo, with the ability to track pyruvate metabolism for nearly 2 minutes post-injection.

The technique has expanded beyond tumor metabolism to non-invasively assess physiological parameters like pH, highlighting its growing potential in medical research, especially with the increasing availability of dynamic nuclear polarization (DNP) systems for generating hyperpolarized materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 13carbon MR. Rowland, IJ., Peterson, ET., Gordon, JW., et al.[2019]

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 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]

The study introduces a novel imaging technique called hyper PET, which combines hyperpolarized (13)C-pyruvate magnetic resonance spectroscopic imaging (MRSI) with (18)F-FDG-PET imaging, successfully demonstrated in a canine cancer patient.

This method allows for direct observation of the Warburg Effect in tumors by measuring the conversion of (13)C-pyruvate to (13)C-lactate, providing insights into tumor metabolism that traditional (18)F-FDG-PET imaging cannot distinguish.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous hyperpolarized (13)C-pyruvate MRI and (18)F-FDG-PET in cancer (hyperPET): feasibility of a new imaging concept using a clinical PET/MRI scanner. Gutte, H., Hansen, AE., Henriksen, ST., et al.[2020]

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]

References

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

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

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

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

Hyperpolarized 13carbon MR. [2019]

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

Metabolic Imaging as a Biomarker of Early Radiation Response in Tumors. [2018]

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

Hyperpolarized 13C MRI: Path to Clinical Translation in Oncology. [2023]

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

Simultaneous hyperpolarized (13)C-pyruvate MRI and (18)F-FDG-PET in cancer (hyperPET): feasibility of a new imaging concept using a clinical PET/MRI scanner. [2020]

7. 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]