Metabolic Characteristics of Sarcoma In Vivo Using HP 13-C Magnetic Resonance Spectroscopic Imaging (MRSI) (HPMSS)

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

Investigators will determine whether MRSI using hyperpolarized [1-13C]pyruvate provide useful information of tumor malignancy in MRI-indeterminate cases. Metabolite maps of hyperpolarized [1-13C]lactate and H13CO3- produced from hyperpolarized [1-13C]pyruvate will be compared to the biopsy results of MRI-indeterminate patients and the 13C-maps of age-matched healthy subjects.

Study Overview

• Status: Withdrawn
• Conditions: Sarcoma, Soft Tissue
• Intervention / Treatment: Drug: Hyperpolarized 13CPyruvate

Detailed Description

A non-randomized, interventional (nontherapeutic), feasibility trial to detect metabolic changes in participants with musculoskeletal sarcoma using hyperpolarized [1-13C]pyruvate Magnetic Resonance Spectroscopy Imaging (MRSI). All measured quantities will be tabulated and the analysis will be descriptive and obervational in nature.

Participants in this study will receive the study drug, hyperpolarized [1-13C]pyruvate, as a bolus injection during an MRSI of either a soft tissue sarcoma or healthy tissue. After the study drug injection and MRSI, participants will then receive contrast material, Gadavist, via injection during continuation the MRI.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Advanced Imaging Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Eligible study participants will be identified by referring physicians from a UT Southwestern Clinic. A treating physician will discuss the potential research opportunity with their patient to determine interest in study participation.

Description

Inclusion Criteria:

SARCOMA patients:

- MRI indeterminate solid enhancing lesion in the pelvis or extremity.

ALL subjects:

• Age 18 through 100 years.
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• 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 or Spanish language.

Exclusion Criteria:

SARCOMA patients:

-Subjects who have had radiotherapy to the indeterminate lesion.

ALL subjects:

• Subjects who have had chemotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Subjects may not be receiving any other investigational agents.
• Any contraindication per MRI Screening form including implants contraindicated at 3T, pacemakers, implantable Cardioverter Defibrillator (ICD), claustrophobia.
• Metallic foreign bodies in the field of view which may interfere with MRI acquisitions.
• Since each subject is receiving a gadolinium based contrast agent intravenously, additional contraindications would include: eGFR ≤ 30 mL/min/1.73m2, sickle cell disease, or hemolytic anemia.
• Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements.
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hyperpolarized 13CPyruvate and gadolinium; Injection with hyperpolarized 13CPyruvate followed by gadolinium during MRSI.	Drug: Hyperpolarized 13CPyruvate; Bolus injection of study drug during MRSI.; Other Names: HP Pyruvate injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The product ratio difference of lactate to bicarbonate in tumor bearing regions from those in the normal-appearing tissue.	How much metabolic contrast can be detected using hyperpolarized Carbon-13 pyruvate	One day visit with injection during MRSI

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): August 26, 2021
• Study Completion (Actual): August 26, 2021

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): November 30, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Musculoskeletal Sarcoma
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: STU 072017-069

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No