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

NCT03324360 | Recruiting Phase 1

• 1 other identifier: 333-2014
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Brain Metastases

Outcome Measures

Primary Outcomes (1)

• Is an MRI image produced? Y/N?

  To demonstrate the first 13C-metabolic images of the human brain, alone with the required hardware and data acquisition methods.

  ~30-60 minutes of MRI time.

Study Arms (3)

Control Participants Part I

EXPERIMENTAL

A MRI with injection of hyperpolarized 13C pyruvate.

Drug: Hyperpolarized 13C-Pyruvate

Intracranial Metastasis Part II

EXPERIMENTAL

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

Drug: Hyperpolarized 13C-Pyruvate

Intracranial Metastasis Part III

EXPERIMENTAL

MRI with injection of hyperpolarized 13C pyruvate prior to radiation treatment. MRI with injection of hyperpolarized 13C pyruvate following radiation treatment. MRI with injection of hyperpolarized 13C pyruvate following radiation treatment if adverse radiation effect is identified on post-SRS follow-up images.

Drug: Hyperpolarized 13C-Pyruvate

Interventions

Hyperpolarized 13C-Pyruvate DRUG

MRI with Hyperpolarized 13C-Pyruvate Injection

Control Participants Part I; Intracranial Metastasis Part II; Intracranial Metastasis Part III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part I (Controls) Group A
• Participants of all ethnic groups/race categories (≥18yrs old)
• Informed consent Group B
• Male participants of all ethnic groups/race categories (between the age of 18-39)
• Informed consent Group C
• Female participants of all ethnic groups/race categories (between the age of 18-39)
• Informed consent Group D
• Male participants of all ethnic groups/race categories (between the age of 40-59)
• Informed consent Group E
• Female participants of all ethnic groups/race categories (between the age of 40-59)
• Informed consent Group F
• Male participants of all ethnic groups/race categories (≥60 yrs old)
• Informed consent Group G
• Female participants of all ethnic groups/race categories (≥60 yrs old)
• Informed consent Group H and I

You may not qualify if:

• Prior brain radiotherapy for the specific index or lesion to be imaged in the study
• For groups B to I, L, and M only: Montreal Cognitive Assessment (MoCA) score \<26
• The participant will also be asked to complete the standard MRI safety screening questionnaire, prior to their research scan and participation in the study.
• Contraindications to MRI including:
• Participants weighing \>136 kg (weight limit for the scanner tables)
• Participants with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI.
• Pregnant
• Claustrophobia to the extent that the participant cannot stay in the MRI for 45-60 minutes
• Known adverse reactions to the contrast agent Gd-DTPA
• Inability to lie still for 45-60 minutes
• Participants with a high risk factor for nephrogenic systemic fibrosis (NFS).
• Participant declines the procedure or further procedures;
• Participant is not well enough to undergo MRI scanning;
• Participant is unable to complete the MRI procedure for any reason or is non-compliant with MRI requirements.
• For groups J and K, a \<1 lacunar infarct or any cortical subcortical infarct or moderate to severe white matter disease

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Charles Cunningham, PhD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Norberto Garcia

CONTACT

416.480.6100; norberto.garcia@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 27, 2017
• Study Start: December 6, 2017
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)