Ignite Creation Date:
2025-12-24 @ 7:54 PM
Ignite Modification Date:
2025-12-25 @ 5:30 PM
Study NCT ID:
NCT03759704
Status:
WITHDRAWN
Last Update Posted:
2022-04-04
First Post:
2018-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metabolic Characteristics of Sarcoma In Vivo Using HP 13-C Magnetic Resonance Spectroscopic Imaging (MRSI)
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Investigating Metabolic Characteristics of Musculoskeletal Sarcoma In Vivo Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)
Status:
WITHDRAWN
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants meeting inclusion criteria were found.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPMSS
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: