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No participants meeting inclusion criteria were found.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperpolarized 13CPyruvate and gadolinium | Injection with hyperpolarized 13CPyruvate followed by gadolinium during MRSI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperpolarized 13CPyruvate | Drug | Bolus injection of study drug during MRSI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The product ratio difference of lactate to bicarbonate in tumor bearing regions from those in the normal-appearing tissue. | How much metabolic contrast can be detected using hyperpolarized Carbon-13 pyruvate | One day visit with injection during MRSI |
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Inclusion Criteria:
SARCOMA patients:
- MRI indeterminate solid enhancing lesion in the pelvis or extremity.
ALL subjects:
Exclusion Criteria:
SARCOMA patients:
-Subjects who have had radiotherapy to the indeterminate lesion.
ALL subjects:
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Eligible study participants will be identified by referring physicians from a UT Southwestern Clinic. A treating physician will discuss the potential research opportunity with their patient to determine interest in study participation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Imaging Research Center | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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