NCT03759704

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

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
DRUG	Hyperpolarized 13CPyruvate	Bolus injection of study drug during MRSI.

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-08-26
• Completion: 2021-08-26
• First posted: 2018-11-30
• Last updated: 2022-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study