Viewing Study NCT03759704



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Last Modification Date: 2024-10-26 @ 12:59 PM
Study NCT ID: NCT03759704
Status: WITHDRAWN
Last Update Posted: 2022-04-04
First Post: 2018-04-11

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: University of Texas Southwestern Medical Center

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Status: WITHDRAWN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 1-13Cpyruvate provide useful information of tumor malignancy in MRI-indeterminate cases Metabolite maps of hyperpolarized 1-13Clactate and H13CO3- produced from hyperpolarized 1-13Cpyruvate 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 1-13Cpyruvate 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 1-13Cpyruvate 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: None
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?: None