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

Q: Who can participate in NCT03324360?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT03324360?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

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

Role of Hyperpolarized 13C-Pyruvate MR Spectroscopy in Patients With Intracranial Metastasis Treated With (SRS) (NCT03324360) is a Phase 1 interventional studying Brain Metastases, sponsored by Sunnybrook Health Sciences Centre. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About 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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Brain Metastases, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 276 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Brain Metastases subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: Part I (Controls) Group A - Participants of all ethnic groups/race categories (≥18yrs old) - willing to sign a consent form Group B - Male participants of all ethnic groups/race categories (between the age of 18-39) - willing to sign a consent form Group C - Female participants of all ethnic groups/race categories (between the age of 18-39) - willing to sign a consent form Group D - Male participants of all ethnic groups/race categories (between the age of 40-59) - willing to sign a consent form Group E - Female participants of all ethnic groups/race categories (between the age of 40-59) - willing to sign a consent form Group F - Male participants of all ethnic groups/race categories (≥60 yrs old) - willing to sign a consent form Group G - Female participants of all ethnic groups/race categories (≥60 yrs old) - willing to sign a consent form Group H and I - Male or female participants of all ethnic groups/race categories (≥18 yrs old) - willing to sign a consent form Group J - Male or female participants of all ethnic groups/race categories (≥60 yrs old) - willing to sign a consent form - Diagnosed with mild cognitive impairment Group K - Male or female participants of all ethnic groups/race categories (≥60 yrs old) - willing to sign a consent form - Diagnosed with mild Alzheimer's disease Group L - Male or female participants of all ethnic groups/race categories (≥18 years of age) - willing to sign a consent form Group M - Male or female participants of all ethnic groups/race categories (≥18 years of age) - willing to sign a consent form Part II \& III - Adult participants of all ethnic groups/race categories (age ≥18 yrs old) - Radiographic diagnosis of brain metastases and pathological confirmation of a solid cancer primary - Metastatic brain tumor amenable to Stereotactic radiosurgery or radiotherapy - Participants on dexamethasone must be on a stable dose at the time of baseline MRI and 1-5 days post-SRS MRI ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 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 * Male or female participants of all ethnic groups/race categories (≥18 yrs old) * Informed consent Group J * Male or female participants of all ethnic groups/race categories (≥60 yrs old) * Informed consent * Diagnosed with mild cognitive impairment Group K * Male or female participants of all ethnic groups/race categories (≥60 yrs old) * Informed consent * Diagnosed with mild Alzheimer's disease Group L * Male or female participants of all ethnic groups/race categories (≥18 years of age) * Informed consent Group M * Male or female participants of all ethnic groups/race categories (≥18 years of age) * Informed consent Part II \& III * Adult participants of all ethnic groups/race categories (age ≥18 yrs old) * Radiographic diagnosis of brain metastases and pathological confirmation of a solid cancer primary * Metastatic brain tumor amenable to Stereotactic radiosurgery or radiotherapy * Participants on dexamethasone must be on a stable dose at the time of baseline MRI and 1-5 days post-SRS MRI * Estimated survival more than 6 months * Informed consent Exclusion Criteria: * 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 * For groups J and K, any other structural brain lesion that could affect cognition

Treatments Being Tested

DRUG

Hyperpolarized 13C-Pyruvate

MRI with Hyperpolarized 13C-Pyruvate Injection

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT03324360), the sponsor (Sunnybrook Health Sciences Centre), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT03324360 clinical trial studying?

Who can participate in NCT03324360?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT03324360?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT03324360. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT03324360. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.