Back to results

Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma

Primary Purpose

Recurrent World Health Organization (WHO) Grade II Glioma, Recurrent WHO Grade III Glioma, WHO Grade II Glioma

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Hyperpolarized Carbon C 13 Pyruvate

Magnetic Resonance Imaging

Magnetic Resonance Spectroscopic Imaging

About this trial

This is an interventional diagnostic trial for Recurrent World Health Organization (WHO) Grade II Glioma focused on measuring Glioma, Hyperpolarized Pyruvate (13C)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

For patients in cohort 1: histologically proven lower grade glioma who are being followed with surveillance scans
For patients in cohort 2: histologically proven glioma who are scheduled for treatment due to suspected residual or recurrent tumor
Patients with a life expectancy > 12 weeks
Patients must have a Karnofsky performance status of > 60
Patients must have adequate renal function (creatinine < 1.5 mg/dL) before imaging. These tests must be performed within 60 days prior to the hyperpolarized imaging scan.
Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent.
Patients must not have New York Heart Association (NYHA) grade II or greater congestive heart failure
Patients must not have history of myocardial infarction or unstable angina within 12 months prior to study enrollment
This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race
Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information
Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation
Patients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless they are in complete remission and have been off all therapy for that disease for a minimum of 3 years
Patients must not be pregnant or breast-feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of hyperpolarized imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential

Exclusion Criteria:

Subjects will be excluded from participating in this study if they are unable to comply with study and/or follow-up procedures

Sites / Locations

University of California, San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT)

Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI)

Arm Description

Patients undergo MRI and MRSI scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care. Participants enrolled in cohort 1 may later enroll in cohort 2 of study once eligibility has been reviewed and approved by neuro-oncologist

Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate IV over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.

Outcomes

Primary Outcome Measures

Number of treatment-emergent adverse events (AEs)

Safety evaluation for endpoint will include monitoring for the occurrence of treatment-emergent adverse events (AEs). Reported toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0. All available safety data will be used and will be analyzed using descriptive statistics.

Peak lactate/pyruvate

The peak lactate/pyruvate in tumor and normal appearing brain tissue will be reported.

Peak bicarbonate/pyruvate

The peak bicarbonate/pyruvate in tumor and normal appearing brain tissue will be reported.

Change in peak lactate/pyruvate between scans

The change in peak lactate/pyruvate between scans will be reported.

Change in peak bicarbonate/pyruvate between scans

The change in peak bicarbonate/pyruvate between scans will be reported.

Secondary Outcome Measures

Full Information

NCT ID

NCT04540107

First Posted

August 31, 2020

Last Updated

September 11, 2023

Sponsor

Susan Chang

Collaborators

GE Healthcare, Sigma-Aldrich, Phillips-Medisize

1. Study Identification

Unique Protocol Identification Number

NCT04540107

Brief Title

Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma

Official Title

Metabolic Imaging of Patients With Lower Grade Glioma Using Hyperpolarized 13C Pyruvate

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 11, 2017 (Actual)

Primary Completion Date

January 1, 2025 (Anticipated)

Study Completion Date

January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Susan Chang

Collaborators

GE Healthcare, Sigma-Aldrich, Phillips-Medisize

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This trial studies how well serial magnetic resonance (MR) imaging and MR spectroscopic imaging work in characterizing lower grade glioma. Diagnostic procedures, such as MR imaging and MR spectroscopic imaging, may detect serial changes in lower grade glioma. This study may help researchers learn more about practical ways of evaluating and standardizing treatment in patients with brain tumors.

Detailed Description

PRIMARY OBJECTIVES: I. To assess the safety and feasibility of hyperpolarized 13C MR metabolic imaging as a new and unique tool for making an early assessment of progression and evaluation of response to therapy in patients with lower grade glioma II. To determine whether changes in levels of hyperpolarized 13C pyruvate, lactate and bicarbonate may provide early evidence of tumor progression in patients with lower grade glioma who are being followed with surveillance scans. III. To determine whether patients with lower grade glioma who are receiving treatment exhibit a reduction in levels of hyperpolarized 13C lactate/pyruvate at follow-up compared to their baseline scan. OUTLINE: Patients will be enrolled into Cohort 2. Participants previously enrolled in Cohort 1 may enroll in Cohort 2 of study upon re-review of eligibility. COHORT 1 (CLOSED TO ENROLLMENT): Patients undergo MR imaging (MRI) and MR spectroscopic imaging (MRSI) scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care. COHORT 2: Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent World Health Organization (WHO) Grade II Glioma, Recurrent WHO Grade III Glioma, WHO Grade II Glioma, WHO Grade III Glioma

Keywords

Glioma, Hyperpolarized Pyruvate (13C)

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT)

Arm Type

Experimental

Arm Description

Arm Title

Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Hyperpolarized Carbon C 13 Pyruvate

Other Intervention Name(s)

Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)

Intervention Description

Given IV

Intervention Type

Procedure

Intervention Name(s)

Magnetic Resonance Imaging

Other Intervention Name(s)

Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Intervention Description

Undergo MRI

Intervention Type

Procedure

Intervention Name(s)

Magnetic Resonance Spectroscopic Imaging

Other Intervention Name(s)

1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS, MRS Imaging, MRSI, Proton Magnetic Resonance Spectroscopic Imaging

Intervention Description

Undergo MRSI

Primary Outcome Measure Information:

Title

Number of treatment-emergent adverse events (AEs)

Description

Time Frame

Up to 4 years

Title

Peak lactate/pyruvate

Description

The peak lactate/pyruvate in tumor and normal appearing brain tissue will be reported.

Time Frame

Up to 4 years

Title

Peak bicarbonate/pyruvate

Description

The peak bicarbonate/pyruvate in tumor and normal appearing brain tissue will be reported.

Time Frame

Up to 4 years

Title

Change in peak lactate/pyruvate between scans

Description

The change in peak lactate/pyruvate between scans will be reported.

Time Frame

Baseline up to 4 years

Title

Change in peak bicarbonate/pyruvate between scans

Description

The change in peak bicarbonate/pyruvate between scans will be reported.

Time Frame

Baseline up to 4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: For patients in cohort 1: histologically proven lower grade glioma who are being followed with surveillance scans For patients in cohort 2: histologically proven glioma who are scheduled for treatment due to suspected residual or recurrent tumor Patients with a life expectancy > 12 weeks Patients must have a Karnofsky performance status of >= 60 Patients must have adequate renal function (creatinine < 1.5 mg/dL) before imaging. These tests must be performed within 60 days prior to the hyperpolarized imaging scan. Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent. Patients must not have New York Heart Association (NYHA) grade II or greater congestive heart failure Patients must not have history of myocardial infarction or unstable angina within 12 months prior to study enrollment This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation Patients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless they are in complete remission and have been off all therapy for that disease for a minimum of 3 years Patients must not be pregnant or breast-feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of hyperpolarized imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential Exclusion Criteria: Subjects will be excluded from participating in this study if they are unable to comply with study and/or follow-up procedures

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wendy Ma

Phone

877-827-3222

cancertrials@ucsf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan M Chang, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wendy Ma

Phone

877-827-3222

cancertrials@ucsf.edu

First Name & Middle Initial & Last Name & Degree

Susan M. Chang, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma

We'll reach out to this number within 24 hrs