Sarcoma, Soft TissueHPMSSNCT03759704
Metabolic Characteristics of Sarcoma In Vivo Using HP 13-C Magnetic Resonance Spectroscopic Imaging (MRSI)
An observational study of Sarcoma, Soft Tissue, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcoma, Soft Tissue
- What is being tested?
- Hyperpolarized 13CPyruvate
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 26 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Imaging Research Center
Dallas, Texas, 75390
About this study
Official title: Investigating Metabolic Characteristics of Musculoskeletal Sarcoma In Vivo Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)
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.
Read the 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.
- Conditions
- Sarcoma, Soft Tissue
- Being tested
- Hyperpolarized 13CPyruvate
- Keywords
- Musculoskeletal Sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 13CPyruvateDrug
Also called HP Pyruvate injection
Bolus injection of study drug during MRSI.
| Study group | Role | What they receive |
|---|---|---|
| Hyperpolarized 13CPyruvate and gadolinium | Injection with hyperpolarized 13CPyruvate followed by gadolinium during MRSI. Receives: Drug: Hyperpolarized 13CPyruvate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One day visit with injection during MRSI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Jan 2019
- Primary completion26 Aug 2021
- Study completion26 Aug 2021
Why it stopped: No participants meeting inclusion criteria were found.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma, Soft TissueStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Mo Park, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759704
- Sponsor's protocol ID
- STU 072017-069
- Acronym
- HPMSS
- Status last verified
- Mar 2022
- First submitted
- 11 Apr 2018
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Metabolic Characteristics of Musculoskeletal Sarcoma In Vivo Using Hyperpolarized Carbon-13 Magnetic Resonance Spectroscopic Imaging (MRSI)
- ClinicalTrials.gov ID
- NCT03759704
- Acronym / sponsor ID
- HPMSS / STU 072017-069
- Conditions
- Sarcoma, Soft Tissue
- Keywords
- Musculoskeletal Sarcoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants meeting inclusion criteria were found.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 26 Aug 2021 (actual)
- Study completion
- 26 Aug 2021 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperpolarized 13CPyruvate and gadolinium | – | Drug: Hyperpolarized 13CPyruvateInjection with hyperpolarized 13CPyruvate followed by gadolinium during MRSI. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- MRI indeterminate solid enhancing lesion in the pelvis or extremity.
- 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.
Key exclusion criteria (10 listed)
- -Subjects who have had radiotherapy to the indeterminate lesion.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized 13CPyruvateAlso: HP Pyruvate injectionBolus injection of study drug during MRSI. | Drug | Hyperpolarized 13CPyruvate and gadolinium |
Primary outcome
The product ratio difference of lactate to bicarbonate in tumor bearing regions from those in the normal-appearing tissue.
Time frame: One day visit with injection during MRSI
How much metabolic contrast can be detected using hyperpolarized Carbon-13 pyruvate
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, Soft Tissue, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The product ratio difference of lactate to bicarbonate in tumor bearing regions from those in the normal-appearing tissue. (time frame: One day visit with injection during MRSI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.