Metabolic Characteristics of Brain Tumors Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)

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Brief Title

Metabolic Characteristics of Brain Tumors Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)

Official Title

Investigating Metabolic Characteristics of Intracranial Malignancy In Vivo Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)

Brief Summary

      This is a non-randomized, purely observational, feasibility study to detect metabolic changes
      in patients with brain malignancy using a novel hyperpolarized [1-13C]pyruvate MRSI.
    

Detailed Description

      The aim of this pilot study is to test the hypothesis that patients with brain malignancy
      present altered [1-13C]lactate and 13C-bicarbonate production from infused hyperpolarized
      [1-13C]pyruvate in tumor as compared to in normal-appearing brain regions. To achieve this
      aim investigators will assess metabolic phenotype in cancer patients with brain tumors (n =
      8) and in healthy control subjects (n = 8). Total target enrollment will be set at 25
      subjects to allow for attrition and screen failures.

      During each imaging session, following localization of the tumor in brain, tissue
      characteristics and morphological changes will be evaluated with 1H MRI. Then, cerebral
      metabolism will be assessed utilizing 13C MRSI after an intravenous injection with
      hyperpolarized [1-13C]pyruvate. Finally, contrast-enhanced 1H MRI will be acquired. The study
      agent, hyperpolarized [1-13C]pyruvate, will be administered under a Food and Drug
      Administration (FDA) Investigational New Drug (IND), which was approved on 1/3/2017 (IND#
      133229).

      Preliminary data in human are essential to secure larger scale funding required for clinical
      studies. The investigators believe the ability to measure such metabolic shifts in vivo could
      have major significance in assessing the efficacy of multiple anti-tumor therapies currently
      under development that target reversing the Warburg effect as a means of controlling tumor
      growth. Brain tumor applications at the Advanced Imaging Research Center, Harold C. Simmons
      Comprehensive Cancer Center and the Neuro-Oncology Program of the Development of Neurological
      Surgery at the UT Southwestern Medical Center offer today a unique opportunity to lead
      globally the translational scientific efforts in this field.
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

13C-pyruvate Metabolic Product Ratio


Condition

Brain Tumor Adult

Intervention

Hyperpolarized 13C-Pyruvate

Study Arms / Comparison Groups

 Brain Tumor Patients
Description:  Brain Tumor patients will receive a bolus of Hyperpolarized 13C-pyruvate during MRSI.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

25

Start Date

June 1, 2019

Completion Date

December 31, 2020

Primary Completion Date

December 31, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Definitive diagnosis of brain tumors by imaging which demonstrates all kinds of brain
             malignancy, including glioma, meningioma, and brain metastases prior to any
             chemotherapy or radiation treatment.

          -  18-70 years of age

          -  Ability to understand and the willingness to sign a written informed consent.

          -  All races and ethnicities will be included; subjects must be able to read and speak
             the English language. Once the protocol is established, Spanish-speaking participants
             will be included.

          -  Women of child-bearing potential must agree to use adequate contraception (hormonal or
             barrier method of birth control; abstinence) prior to study entry and for the duration
             of study participation.

        Exclusion Criteria:

          -  Subjects who are receiving any other investigational agents.

          -  Previous or current treatment by radiation or chemotherapy.

          -  Concurrent illness including, but not limited to, ongoing or active infection,
             uncontrolled chronic diseases such as hypertension, lung disease, liver disease,
             kidney disease, diabetes, symptomatic congestive heart failure, unstable angina
             pectoris, cardiac arrhythmias, or psychiatric illness/social situations that would
             limit compliance with study requirements.

          -  Subjects who are taking thyroid hormone replacements, have a history of alcohol abuse
             or illicit drug use.

          -  Subjects who have contraindication to contrast enhanced MRI examination, including,
             but not limited to, medical instability, any contraindication on MR Screening Form, or
             an estimated glomerular filtration rate (eGFR) of ≤ 30 mL/min/1.73m2.

          -  Subjects must not be pregnant or nursing due to the potential for congenital
             abnormalities and the potential of this regimen to harm nursing infants
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Jae Mo Park, PhD, 214-645-2726, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03067467

Organization ID

STU 012017-070


Responsible Party

Principal Investigator

Study Sponsor

University of Texas Southwestern Medical Center


Study Sponsor

Jae Mo Park, PhD, Principal Investigator, UT Southwestern


Verification Date

October 2020