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

WHO Grade III Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04540107
• Other study ID #: 161016
• Secondary ID: NCI-2019-08761
• Status: Recruiting
• Phase: Phase 1
• Start date: January 11, 2017
• Est. completion date: January 1, 2025

Study information

• Verified date: September 2023
• Source: University of California, San Francisco
• Contact: Wendy Ma
• Phone: 877-827-3222
• Email: cancertrials[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Recurrence
• Recurrent WHO Grade III Glioma
• Recurrent World Health Organization (WHO) Grade II Glioma
• WHO Grade II Glioma
• WHO Grade III Glioma

Intervention

Drug:
• Hyperpolarized Carbon C 13 Pyruvate
Given IV

Procedure:
• Magnetic Resonance Imaging
Undergo MRI
• Magnetic Resonance Spectroscopic Imaging
Undergo MRSI

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
Susan Chang	GE Healthcare, Phillips-Medisize, Sigma-Aldrich

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 4 years
Primary	Peak lactate/pyruvate	The peak lactate/pyruvate in tumor and normal appearing brain tissue will be reported.	Up to 4 years
Primary	Peak bicarbonate/pyruvate	The peak bicarbonate/pyruvate in tumor and normal appearing brain tissue will be reported.	Up to 4 years
Primary	Change in peak lactate/pyruvate between scans	The change in peak lactate/pyruvate between scans will be reported.	Baseline up to 4 years
Primary	Change in peak bicarbonate/pyruvate between scans	The change in peak bicarbonate/pyruvate between scans will be reported.	Baseline up to 4 years