Metabolic Characteristics of Sarcoma In Vivo Using HP 13-C Magnetic Resonance Spectroscopic Imaging (MRSI)
Withdrawn before enrolling
Conditions studied: Sarcoma, Soft Tissue
In brief
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.
Key facts
- Study ID
- NCT03759704
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 0
- Starts
- 2019-01-01
- Expected to finish
- 2021-08-26
- Last updated by the study team
- 2022-04-04
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Advanced Imaging Research Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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