Clinical trial NCT03067467: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Tumor Adult
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 Brain Tumor Patients

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 = 20). Total target enrollment will be set at 25 subjects to account for attrition and screening 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.

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 have a history of alcohol abuse or illicit drug use.
* Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
* Subjects who have contraindication to contrast enhanced MRI examination

Contraindications to MRI examination include:

* Medically unstable

  * Heart failure
  * Severe LVOT outflow obstruction
  * Unstable angina
  * Child bearing
  * Lactating
* Any contraindication per MRI Screening Form including

  * Implants contraindicated at 3T, pacemakers
  * Implantable Cardioverter Defibrillator (ICD)
  * Claustrophobia
* Since each subject may be receiving a gadolinium-based contrast agent intravenously:

  * eGFR ≤ 30 mL/min/1.73m2
  * Sickle cell disease
  * Hemolytic anemia

Primary outcomes:
measure: 13C-pyruvate Metabolic Product Ratio
timeFrame: Screening (Baseline) and 1 day of Study Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern
name: Jae Mo Park, PhD
role: PRINCIPAL_INVESTIGATOR
References: