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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special type of MRI, called hpMRI, using a contrast agent called hyperpolarized 13-C-pyruvate, can predict how well patients with thyroid cancer and other head and neck cancers will respond to treatment. The goal is to determine if this scan can assist doctors in planning the best treatment for these patients. Individuals with thyroid cancer or other head and neck cancers who are about to start treatment might be suitable candidates for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

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 prior data suggests that hpMRI is safe for patients with thyroid cancer and other head and neck malignancies?

Research has shown that hyperpolarized Carbon C 13 Pyruvate, used in special MRI scans, is generally safe for people. This imaging agent has been tested in various cancers, such as thyroid and prostate, to observe tumor responses to treatment.

In past studies, using hyperpolarized Carbon C 13 Pyruvate in MRI scans did not cause major side effects, suggesting its safety for imaging tests. It is important to note that this trial is in an early stage, focusing primarily on safety. Early trials typically involve a small number of participants but help determine if a treatment is safe enough for further research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it involves the use of hyperpolarized carbon C 13 pyruvate in hpMRI scans, which is a novel approach for imaging thyroid cancer and other head and neck malignancies. This method provides real-time metabolic insights by enhancing the visibility of cancer cells during MRI, potentially allowing for earlier and more precise detection compared to standard imaging techniques like ultrasound, CT, and regular MRI. Additionally, this technique could offer a non-invasive way to monitor how effectively a treatment is working shortly after it begins, which is a significant advantage over traditional methods that might take longer to show results.

What evidence suggests that hpMRI is effective for predicting treatment response in thyroid cancer?

Research has shown that a special imaging method using hyperpolarized Carbon C 13 Pyruvate can reveal how thyroid cancer and other head and neck cancers respond to treatment. In this trial, patients with these cancers will undergo hpMRI scans to track tumor changes during therapy. Studies with thyroid cancer models have demonstrated this method's promise, offering real-time insights into treatment effectiveness. This technique has also effectively monitored tumor response in other cancers, such as breast and prostate. Therefore, it could provide a promising way to adjust treatment plans based on cancer's reaction. ^{1 5 6 7 8}

Who Is on the Research Team?

Stephen Y. Lai

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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 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 (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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24475215/

Evaluation of hyperpolarized [1-¹³C]-pyruvate by magnetic ... This hypothesis was tested in a pre-clinical model of anaplastic thyroid carcinoma (ATC), an aggressive head and neck malignancy. Human ATC ...

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

Hyperpolarized Pyruvate (13C) Injection Patients with Thyroid Cancer and Other. Malignancies of the Head and Neck. Undergoing Radiation Therapy and/or. Systemic Therapy. Recruiting. Thyroid Carcinoma.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4628838/

High-Throughput Hyperpolarized 13C Metabolic ... Various responses to HP [1-13C] pyruvate were demonstrated in controlled enzyme phantoms ex vivo, cancer cells in vitro, and anaplastic thyroid tumors in vivo.

4. researchgate.net researchgate.net/publication/259961284_Evaluation_of_Hyperpolarized_1-13C-Pyruvate_by_Magnetic_Resonance_to_Detect_Ionizing_Radiation_Effects_in_Real_Time

Pyruvate by Magnetic Resonance to Detect Ionizing ... Diagnostic methods based on hyperpolarised DNP-MR for solid tumors can be used to follow in a non-invasive manner the biological effects of radiation via ...

5. withpower.com withpower.com/trial/hyperpolarized-13c-pyruvate-mri-for-solid-cancers-49259

Hyperpolarized 13C-Pyruvate MRI for Solid Cancers This technique has been used in various cancers, including breast and prostate cancer, to provide real-time information on how tumors respond to therapy, ...

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

Hyperpolarized Carbon 13 MRI: Clinical Applications and ... Clinical Applications of Hyperpolarized [1-13C]Pyruvate MRI in Oncology. Metabolic Profiling of Tumors. Malignant transformation is associated with a metabolic ...

7. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.2019182391

Hyperpolarized 13C MRI: State of the Art and Future ... Hyperpolarized (HP) carbon 13 (13C) MRI is an emerging molecular imaging method that allows rapid, noninvasive, and pathway-specific ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/27/NCT04565327/Prot_SAP_000.pdf

Hyperpolarized 13C pyruvate MRI for treatment response ... (13)C Pyruvate Demonstrates (13)C Lactate Production in Brain Tumor Patients. ... burden of thyroid, liver, and pancreas cancers in the United States.