Role of Hyperpolarized 13C-Pyruvate MR Spectroscopy in Patients With Intracranial Metastasis Treated With (SRS)

Official Title

The Feasibility and Role of Hyperpolarized 13C-Pyruvate MR Spectroscopy in Monitoring Patients With Intracranial Metastasis Treated With Stereotactic Radiosurgery (SRS)

Summary:

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 tumours - such as tumour hypoxia and lactate accumulation - and clinical outcomes in order to guide management. These characteristics may predict future tumour behaviour 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.

Trial Description

Primary Outcome:

  • Is an MRI image produced? Y/N?
This is a pilot prospective, single-institution study in both healthy participants and particpants with evidence of intracranial metastases who will be planned for brain radiation therapy. Healthy particpant accural will be done through advertisments. Intracranical metastatic participant screening and accrual will be completed by a member of the participant's Cirlce of Care. Clinical procedures will be completed at Sunnybrook Health Sciences Centre (SHSC) by the study's Qualified Investigator or medical designate. Eligible healthy particpants must meet the study's inclusion and exclusion crtieria and MRI eligibility. Intracranial metastatic particpants must meet the study's inclusion and exclusion crtieria, MRI eligibility will be undergoing radiation therapy (stereotactic radiation therapy). The study will be divided into three parts: Part I
  • Population: up to 86 healthy study participants, ≥18 years of age
  • Each participant in Groups A to G will undergo a single MRI sequence with a single hyperpolarized 13C pyruvate injection. Participants in group H and I will undergo MRI sequences with two consecutive injections of hyperpolarized 13C pyruvate. The scans are expected to be of approximately 60 to 75 minutes in length. Group A: up to 6 healthy participants ≥> 18 years of age. Group B: up to 10 healthy male participants between the age of 18-39 Group C: up to 10 healthy female participants between the age of 18-39 Group D: up to 10 healthy male participants between the age of 40-59 Group E: up to 10 healthy female participants between the age of 40-59 Group F: up to 10 healthy male participants ≥> 60 years of age Group G: up to 10 healthy female participants ≥> 60 years of age Group H: up to 10 healthy male or female participants ≥ 18 years of age Group I: up to 10 healthy male or female participants ≥ 18 years of age Part II
  • Population: up to 5 study participants from the Odette Cancer Centre, ≥18 years of age with demonstrated intracranial metastasis on imaging (CT or MRI), who have been referred to clinic for radiation therapy consideration.
  • Procedure: Each participant will undergo additional MRI sequences (hyperpolarized 13C pyruvate MRS) with an additional length of approximately 30-60 minutes that will be performed on the day of or in advance of the participant's routine radiation planning scan prior to radiation treatment. No extra visits to the hospital, beyond routine clinical care, are anticipated. Part III
  • Population: up to 30 study participants from the Odette Cancer Centre, ≥18 years of age with demonstrated intracranial metastasis on imaging (CT or MRI), who have been referred to clinic for radiation therapy consideration.
  • Procedure: Each participant will undergo additional MRI sequences (hyperpolarized 13C pyruvate MRS) with an additional length of approximately 30-60 minutes that will be performed on the day of or in advance of the participant's routine radiation planning scan prior to radiation treatment In addition, each participant will undergo one non-routine MRI scan with a length of approximately 60-90 minutes at a time point of 1-5 days following radiation treatment.

View this trial on ClinicalTrials.gov

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