Malignant Central Nervous System NeoplasmPhase 1NCT03565367
Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors
A Phase 1 study testing Gadolinium, Hyperpolarized Carbon C 13 Pyruvate and Magnetic Resonance Imaging in people with Malignant Central Nervous System Neoplasm and Metastatic Malignant Neoplasm in the Central Nervous System, run by Daniel M. Spielman at 1 site in United States.
Trial summary
This early phase I trial studies how well hyperpolarized carbon C 13 pyruvate magnetic resonance imaging works in detecting lactate and bicarbonate in participants with central nervous system tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Central Nervous System Neoplasm, Metastatic Malignant Neoplasm in the Central Nervous System
- What is being tested?
- Gadolinium, Hyperpolarized Carbon C 13 Pyruvate and Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2018to 20 Jun 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a known diagnosis of central nervous system (CNS) malignancy, including metastases, with known enhancement on magnetic resonance (MR) who are otherwise eligible to undergo MRI
- Glomerular filtration rate (GFR) > 30 ml/min
- No allergy to gadolinium
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Refusal to have an IV placed for injection
- Acute major illness (e.g., unstable angina, etc.) or other condition that makes participation unsafe, per the investigator?s judgement
- Total bilirubin > 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 x ULN
- Gamma-glutamyltransferase (GGT) > 2.5 x ULN
- Pregnant or breast-feeding
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- Cardiovascular risk, including:
- Poorly controlled hypertension, defined as either systolic > 170 or diastolic > 110
- Congestive heart failure
- Myocardial infarction within the past year
- QT prolongation, defined as pretreatment corrected QT interval (QTc) > 440 msec in males or > 460 msec in females
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Palo Alto, California, 94304
About this study
Official title: A Pilot Study to Assess Lactate and Bicarbonate Detection Within Malignant Brain Tumors Using [1-13C]-Pyruvate DNP Magnetic Resonance Spectroscopy (MRS)
This early phase I trial studies how well hyperpolarized carbon C 13 pyruvate magnetic resonance imaging works in detecting lactate and bicarbonate in participants with central nervous system tumors. Hyperpolarized carbon C 13 pyruvate magnetic resonance imaging may be used to measure the metabolic state of malignant brain tumors.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the safety of intravenous (IV) injection of hyperpolarized carbon C 13 pyruvate (hyperpolarized [1-13C] pyruvate) for magnetic resonance imaging (MRI).
II. To assess the frequency and sensitivity with which lactate and bicarbonate signals can be detected in malignant brain tumors after IV injection of hyperpolarized [1-13C] pyruvate.
OUTLINE:
Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo magnetic resonance spectroscopic imaging (MRSI) over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).
After completion of study, participants are followed up periodically.
- Conditions
- Malignant Central Nervous System Neoplasm, Metastatic Malignant Neoplasm in the Central Nervous System
- Being tested
- Gadolinium, Hyperpolarized Carbon C 13 Pyruvate, Magnetic Resonance Imaging, Magnetic Resonance Spectroscopic Imaging
- Medical subject headings
- Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GadoliniumOther
Also called Gd
gadolinium enhanced MRI
Hyperpolarized Carbon C 13 PyruvateDrug
Also called Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan
Undergo MRI
Magnetic Resonance Spectroscopic ImagingProcedure or surgery
Also called 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS
Undergo MRSI
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes. Receives: Drug: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Imaging; Procedure: Magnetic Resonance Spectroscopic Imaging |
| Known CNS Malignancy | Experimental | Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director). Receives: Other: Gadolinium; Drug: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Imaging; Procedure: Magnetic Resonance Spectroscopic Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Grade 2 or Higher Toxicities
The measurement of this drug is the number of participants with Grade 2 or higher related adverse events (except for asymptomatic lab increases)
Measured: 2 days (+/-2) after the scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start6 Nov 2018
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant Central Nervous System NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel M. Spielman
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Daniel M. Spielman, Stanford University
- Investigators
- Lawrence Recht, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565367
- Sponsor's protocol ID
- IRB-39845
- Other IDs
- NCI-2018-01122, IRB-39845, BRN0036, R01CA245097-01A1
- Status last verified
- Nov 2023
- First submitted
- 11 Jun 2018
- Last updated
- 21 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Lactate and Bicarbonate Detection Within Malignant Brain Tumors Using [1-13C]-Pyruvate DNP Magnetic Resonance Spectroscopy (MRS)
- ClinicalTrials.gov ID
- NCT03565367
- Acronym / sponsor ID
- IRB-39845
- Conditions
- Malignant Central Nervous System Neoplasm, Metastatic Malignant Neoplasm in the Central Nervous System
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Daniel M. SpielmanUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Posted 18 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This early phase I trial studies how well hyperpolarized carbon C 13 pyruvate magnetic resonance imaging works in detecting lactate and bicarbonate in participants with central nervous system tumors. Hyperpolarized carbon C 13 pyruvate magnetic resonance imaging may be used to measure the metabolic state of malignant brain tumors.
Detailed description
PRIMARY OBJECTIVES:
- To assess the safety of intravenous (IV) injection of hyperpolarized carbon C 13 pyruvate (hyperpolarized [1-13C] pyruvate) for magnetic resonance imaging (MRI).
II. To assess the frequency and sensitivity with which lactate and bicarbonate signals can be detected in malignant brain tumors after IV injection of hyperpolarized [1-13C] pyruvate.
OUTLINE:
Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo magnetic resonance spectroscopic imaging (MRSI) over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).
After completion of study, participants are followed up periodically.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Drug: Hyperpolarized Carbon C 13 Pyruvate, Procedure: Magnetic Resonance Imaging, Procedure: Magnetic Resonance Spectroscopic ImagingParticipants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes. |
| Known CNS Malignancy | Experimental | Other: Gadolinium, Drug: Hyperpolarized Carbon C 13 Pyruvate, Procedure: Magnetic Resonance Imaging, Procedure: Magnetic Resonance Spectroscopic ImagingParticipants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a known diagnosis of central nervous system (CNS) malignancy, including metastases, with known enhancement on magnetic resonance (MR) who are otherwise eligible to undergo MRI
- Glomerular filtration rate (GFR) > 30 ml/min
- No allergy to gadolinium
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (11 listed)
- Refusal to have an IV placed for injection
- Acute major illness (e.g., unstable angina, etc.) or other condition that makes participation unsafe, per the investigator?s judgement
- Total bilirubin > 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 x ULN
- Gamma-glutamyltransferase (GGT) > 2.5 x ULN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GadoliniumAlso: Gdgadolinium enhanced MRI | Other | Known CNS Malignancy |
| Hyperpolarized Carbon C 13 PyruvateAlso: Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)Given IV | Drug | Healthy Volunteers, Known CNS Malignancy |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI ScanUndergo MRI | Procedure or surgery | Healthy Volunteers, Known CNS Malignancy |
| Magnetic Resonance Spectroscopic ImagingAlso: 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRSUndergo MRSI | Procedure or surgery | Healthy Volunteers, Known CNS Malignancy |
Primary outcome
Number of Participants With Grade 2 or Higher Toxicities
Time frame: 2 days (+/-2) after the scan
The measurement of this drug is the number of participants with Grade 2 or higher related adverse events (except for asymptomatic lab increases)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Recht principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gadolinium, Hyperpolarized Carbon C 13 Pyruvate and Magnetic Resonance Imaging in people with Malignant Central Nervous System Neoplasm and Metastatic Malignant Neoplasm in the Central Nervous System, run by Daniel M. Spielman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Grade 2 or Higher Toxicities (time frame: 2 days (+/-2) after the scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.