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

• Status: Enrolling by invitation
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center

Criteria

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.