Status:
WITHDRAWN
Metabolic Characteristics of Sarcoma In Vivo Using HP 13-C Magnetic Resonance Spectroscopic Imaging (MRSI)
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Sarcoma, Soft Tissue
Eligibility:
All Genders
18-100 years
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 \[1-13C\]l...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 26 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03759704
Start Date
January 1 2019
End Date
August 26 2021
Last Update
April 4 2022
Active Locations (1)
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1
Advanced Imaging Research Center
Dallas, Texas, United States, 75390