156 Participants Needed

Hyperpolarized Pyruvate Imaging for Brain Tumors

JG
NB
NB
Overseen ByNadia Bragagnolo, MSc
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Sunnybrook Health Sciences Centre
Must be taking: Dexamethasone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Upwards of 40% of cancer patients will develop brain metastases during their illness, most of which become symptomatic. The burden of brain metastases impacts the quality and length of survival. Thus the management of brain metastases is a significant health care problem. Standard treatment options include stereotactic radiosurgery and/or whole brain radiation. There is a great interest in studying the association between the functional characteristics of tumors - such as tumour hypoxia and lactate accumulation - and clinical outcomes in order to guide management. These characteristics may predict future tumor behavior and stratify risk of therapy failure. Hyperpolarized 13C MR imaging is a novel functional imaging technique that uses 13C-labeled molecules, such as pyruvate, and MRS to image in vivo tissue metabolism. There is significant clinical heterogeneity in patients with brain metastasis due to differences in underlying tumour biology. Biochemical differences in tumour metabolism have been shown to correlate with response to therapy. While the significance of tissue hypoxia for radiosensitivity has been established for years, the impact of lactate accumulation on radiosensitivity has only recently been recognized. Studies have shown that tissue lactate levels correlate with radioresistance in several human tumours. Hyperpolarized 13C pyruvate MRS has been shown in numerous pre-clinical studies and a recent clinical study to have great potential as a metabolic imaging tool. Our study seeks to establish the role of hyperpolarized 13C MRS in characterizing the metabolic features of intracranial metastasis. The results of this study will provide insight into intracranial metastatic disease signatures with MR spectroscopy and determine if there is added benefit for incorporation of this new technique into future clinical MRI protocols. If the technique can accurately differentiate between aggressive and indolent tumours based on MR spectroscopic patterns, hyperpolarized 13C MRS may have wide-ranging utility in the future. In the era of personalized medicine, the ability of imaging tests to predict response to therapy would open the door for individualized treatment options specific to each patient's disease biology.

Research Team

CC

Charles Cunningham, PhD

Principal Investigator

Sunnybrook Research Institute

Eligibility Criteria

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.
See 8 more

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.
See 3 more

Timeline

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

Treatment Details

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.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Intracranial Metastasis Part IIIExperimental Treatment1 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 IIExperimental Treatment1 Intervention
MRI with injection of hyperpolarized 13C pyruvate prior to radiation treatment.
Group III: Control Participants Part IExperimental Treatment1 Intervention
A MRI with injection of hyperpolarized 13C pyruvate.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials
693
Recruited
1,569,000+
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