RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-06-01

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03067467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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 * 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

Inclusion Criteria

Exclusion 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.

* 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
* 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

Contacts and Locations

Study Contact

Jeannie D Baxter, RN

CONTACT

214-645-2726

jeannie.baxter@utsouthwestern.edu

Principal Investigator

Jae Mo Park, PhD

PRINCIPAL_INVESTIGATOR

UT Southwestern

Study Locations (Sites)

UT Southwestern Medical Center

Dallas, Texas, 75390

United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

Jae Mo Park, PhD, PRINCIPAL_INVESTIGATOR, UT Southwestern

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-01

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2019-06-01

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Brain Tumor Adult