Hyperpolarized Pyruvate Imaging for Brain Tumors

Overseen By Nadia Bragagnolo, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sunnybrook Health Sciences Centre

Must be taking: Dexamethasone

Disqualifiers: Prior brain radiotherapy, Pregnancy, Claustrophobia, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

156 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging technique using a special kind of MRI that involves injecting hyperpolarized 13C-pyruvate. The main goal is to determine if this technique can help doctors better understand brain metastases (cancer that has spread to the brain) and predict how different tumors might respond to treatment. The trial seeks participants diagnosed with brain metastases from solid tumors who have not yet received radiation treatment for these specific brain lesions. This research could lead to more personalized treatment plans based on the unique characteristics of each patient's tumor. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, participants must be on a stable dose of dexamethasone at the time of the MRI scans.

What prior data suggests that hyperpolarized 13C pyruvate MRI is safe for brain tumor imaging?

Research has shown that using a special form of pyruvate for imaging is safe in humans. In a previous study, injecting this compound into patients did not cause any major safety issues. The study found that the imaging process was safe and well-tolerated, with no reports of serious side effects. This technique involves injecting a special type of pyruvate, a substance the body naturally produces, to help doctors observe brain tumor behavior. So far, the safety data appears promising for those considering joining a clinical trial using this method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperpolarized 13C-pyruvate for brain tumors because it offers a novel way to visualize tumor metabolism in real-time using advanced MRI techniques. Unlike traditional imaging methods that primarily focus on structural changes, this approach targets the metabolic activity of tumors, providing potentially faster and more precise insights into treatment responses. Additionally, the technique involves a unique hyperpolarization process that significantly enhances the MRI signal, allowing for clearer and more detailed imaging of tumor dynamics. This could lead to more tailored and effective treatment strategies for patients with brain tumors.

What evidence suggests that hyperpolarized 13C pyruvate MRI is effective for brain tumors?

Research has shown that hyperpolarized 13C-pyruvate serves as a promising tool for imaging brain activity. Studies have found it can reveal differences in how brain tumors use energy, potentially predicting tumor aggressiveness. This imaging method excels at identifying areas with high lactate levels, a substance linked to tumors resisting radiation treatment. In this trial, participants will undergo MRI with an injection of hyperpolarized 13C-pyruvate, either as a control or before radiation treatment, to assess these metabolic changes. This technique could help doctors better understand and treat brain metastases by tailoring treatments to the specific biology of each patient's tumor. ^{3 5 6 7 8}

Who Is on the Research Team?

Charles Cunningham, PhD

Principal Investigator

Sunnybrook Research Institute

Are You a Good Fit for This Trial?

Adults of any ethnicity with brain metastases from solid cancers, at least one tumor over 1 cm suitable for radiosurgery or radiotherapy, on a stable steroid dose, expected to live more than 6 months. Excludes those with prior brain radiotherapy for the lesion in question, certain cognitive impairments, MRI contraindications like pacemakers or severe claustrophobia, known reactions to contrast agents used in MRIs, and inability to lie still.

Inclusion Criteria

I am a man over 60 and willing to give informed consent.

I am 60 years or older and have given my informed consent.

I am an adult with brain metastases from solid cancer, eligible for specific brain tumor treatment, and expected to live more than 6 months.

Exclusion Criteria

You cannot have an MRI if you weigh more than 136 kg, have a pacemaker, cerebral aneurysm clips, shrapnel injury, or certain implantable electronic devices. Pregnant participants, those with severe claustrophobia, known allergic reactions to contrast agent, or high risk for nephrogenic systemic fibrosis are also excluded. Additionally, participants who are unable to lie still, undergo the procedure, or comply with MRI requirements are not eligible.

For groups J and K: You have had a specific type of stroke or have significant white matter disease.

I have a brain condition that could impact my thinking or memory.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI and Hyperpolarized 13C Pyruvate Injection

Participants undergo MRI sequences with hyperpolarized 13C pyruvate injection to assess metabolic features of intracranial metastasis

1 day

1 visit (in-person)

Radiation Treatment Planning

Participants undergo routine radiation planning scan with additional MRI sequences

1 day

1 visit (in-person)

Post-Radiation MRI

Participants undergo a non-routine MRI scan 1-5 days following radiation treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized 13C-Pyruvate

Trial Overview The trial is testing Hyperpolarized 13C-Pyruvate using MR Spectroscopy to see if it can help characterize metabolic features of brain tumors and predict their behavior. This could lead to personalized treatment plans based on individual tumor biology.

How Is the Trial Designed?

Group I: Intracranial Metastasis Part III Experimental Treatment 1 Intervention

MRI with injection of hyperpolarized 13C pyruvate prior to radiation treatment. MRI with injection of hyperpolarized 13C pyruvate1-5 days following radiation treatment.

Group II: Intracranial Metastasis Part II Experimental Treatment 1 Intervention

MRI with injection of hyperpolarized 13C pyruvate prior to radiation treatment.

Group III: Control Participants Part I Experimental Treatment 1 Intervention

A MRI with injection of hyperpolarized 13C pyruvate.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6050093/

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

2. 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.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/mrm.29875

Current methods for hyperpolarized [1‐13C]pyruvate MRI ... MRI with hyperpolarized (HP) 13C agents, also known as HP 13C MRI, can measure processes such as localized metabolism that is altered in ...

4. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/rycan.230005

Hyperpolarized Carbon 13 MRI: Clinical Applications and ... Hyperpolarized carbon 13 MRI ( 13 C MRI) is a novel imaging approach that can noninvasively probe tissue metabolism in both normal and pathologic tissues.

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

Hyperpolarized 13C pyruvate MRI for treatment response ... Study. Description. This is a pilot prospective study to investigate the utility of HP 13C pyruvate MRI for assessing tumor metabolism and monitoring early ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6260457/

Hyperpolarized 13C MRI: Path to Clinical Translation in ... The first-in-human study convincingly demonstrated that injection of HP [1-13C]pyruvate is safe and that imaging metabolic products of hyperpolarized [1-13C] ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03324360

Role of Hyperpolarized 13C-Pyruvate MR Spectroscopy in ... Upwards of 40% of cancer patients will develop brain metastases during their illness, most of which become symptomatic. The burden of brain metastases ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8084843/

Predicting response to radiotherapy of intracranial metastases ... Hyperpolarized (HP) 13 C MRI is an new imaging approach that has the potential to predict radiation treatment failure by probing lactate metabolism in vivo.