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

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.

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.