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

NCT03759704 | Withdrawn DMC FDA Drug

• 1 other identifier: STU 072017-069
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcoma, Soft Tissue

Keywords

Musculoskeletal Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Hyperpolarized 13CPyruvate and gadolinium

Injection with hyperpolarized 13CPyruvate followed by gadolinium during MRSI.

Drug: Hyperpolarized 13CPyruvate

Interventions

Hyperpolarized 13CPyruvate DRUG

Bolus injection of study drug during MRSI.

Also known as: HP Pyruvate injection

Hyperpolarized 13CPyruvate and gadolinium

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Advanced Imaging Research Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: November 30, 2018
• Study Start: January 1, 2019
• Primary Completion: August 26, 2021
• Study Completion: August 26, 2021
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

US (1)