SarcomaNCT07487870
Radiographic Evaluation of Tumor Biology During Neoadjuvant Radiotherapy for Sarcoma
A study testing MRI in people with Sarcoma, run by Andrew Frankart at 1 site in United States.
Trial summary
This is a single arm study in which patients will undergo MRI studies at 3 non-SOC timepoints (end of weeks 1, 3, and 5) while receiving SOC RT for their soft tissue sarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed history of soft tissue sarcoma.
- Plan to receive neoadjuvant radiation to a dose of 50 Gy in 25 fractions followed by surgical resection per Investigator.
- Age ≥18 years.
- ECOG performance status ≤2.
Who cannot join
- Patients with Ewing's sarcoma and rhabdomyosarcoma.
- Unable or unwilling to receive gadolinium-based contrast.
- Patients who are unable or unwilling to undergo MRI studies.
- Patients who may be unlikely or unable to be able to complete 3 additional MRI studies during the course of their 5-week radiation plan in the opinion of the PI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andrew Frankart, MD contact
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Andrew Frankart
Andrew Frankart, MD
About this study
This is a single arm study in which patients will undergo MRI studies at 3 non-SOC timepoints (end of weeks 1, 3, and 5) while receiving SOC RT for their soft tissue sarcoma.
Read the detailed description
The purpose of this research is to determine if additional imaging during radiotherapy allows for better understanding of tumor's response to radiation and better treatment planning. Modern cancer treatment has used imaging to tailor individual patient treatment and to monitor responses to therapy. Typically, assessments of tumor response to radiation are conducted by repeat imaging after completing therapy. It is known that radiation can change aspects of the tumor which impact response to therapy. These changes can potentially be seen in imaging of the tumor. The researchers in this study believe that additional imaging during treatment will allow for more personalized and better treatment for sarcoma.
- Conditions
- Sarcoma
- Being tested
- MRI
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Patients will undergo RT therapy per SOC and will receive 3 additional MRI studies at the end of RT weeks 1, 3, and 5 with an allowable window of +/- 3 days to account for delays in radiation or unforeseeable circumstances which prevent completion of MRI such as illness or weather.
| Study group | Role | What they receive |
|---|---|---|
| MRI studies at 3 non-SOC timepoints (end of weeks 1, 3, and 5) | Experimental | Patients will undergo RT therapy per SOC and will receive 3 additional MRI studies at the end of RT weeks 1, 3, and 5.
Participants will complete their SOC RT and SOC post-radiation MRI imaging. They will then undergo SOC surgical resection at which time a single research specific tissue collection from discarded tissue not required for clinical pathology will be obtained. Patient participation will be completed after the completion of the surgical resection with no additional follow-up or data collection on survival or disease status as the focus of this feasibility study is on tumor changes during treatment.
No other differences from a typical treatment course are expected and no additional anti-cancer therapies will be added as a result of the imaging study results. Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility measured as the percentage of study-specific MRI scans beyond standard of care which are completed
- To evaluate the feasibility of completing serial MRI studies during a course of radiation.
- Feasibility will be measured as the percentage of study-specific MRI scans beyond standard of care which are completed at the end of the study with greater than or equal to a 66% completion rate overall (not per patient) being considered feasible.
Measured: Treatment weeks 1, 3, and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm study
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrew Frankart
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew Frankart, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487870
- Sponsor's protocol ID
- UCCC-RT-25-06
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Evaluation of Tumor Biology During Neoadjuvant Radiotherapy for Sarcoma
- ClinicalTrials.gov ID
- NCT07487870
- Acronym / sponsor ID
- UCCC-RT-25-06
- Conditions
- Sarcoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Andrew FrankartUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Mar 2026 (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.
This is a single arm study in which patients will undergo MRI studies at 3 non-SOC timepoints (end of weeks 1, 3, and 5) while receiving SOC RT for their soft tissue sarcoma.
Detailed description
The purpose of this research is to determine if additional imaging during radiotherapy allows for better understanding of tumor's response to radiation and better treatment planning. Modern cancer treatment has used imaging to tailor individual patient treatment and to monitor responses to therapy. Typically, assessments of tumor response to radiation are conducted by repeat imaging after completing therapy. It is known that radiation can change aspects of the tumor which impact response to therapy. These changes can potentially be seen in imaging of the tumor. The researchers in this study believe that additional imaging during treatment will allow for more personalized and better treatment for sarcoma.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm study
| Arm | Type | Receives |
|---|---|---|
| MRI studies at 3 non-SOC timepoints (end of weeks 1, 3, and 5) | Experimental | Diagnostic Test: MRIPatients will undergo RT therapy per SOC and will receive 3 additional MRI studies at the end of RT weeks 1, 3, and 5. Participants will complete their SOC RT and SOC post-radiation MRI imaging. They will then undergo SOC surgical resection at which time a single research specific tissue collection from discarded tissue not required for clinical pathology will be obtained. Patient participation will be completed after the completion of the surgical resection with no additional follow-up or data collection on survival or disease status as the focus of this feasibility study is on tumor changes during treatment. No other differences from a typical treatment course are expected and no additional anti-cancer therapies will be added as a result of the imaging study results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must have histologically or cytologically confirmed history of soft tissue sarcoma.
- Plan to receive neoadjuvant radiation to a dose of 50 Gy in 25 fractions followed by surgical resection per Investigator.
- Age ≥18 years.
- ECOG performance status ≤2.
Key exclusion criteria (4 listed)
- Patients with Ewing's sarcoma and rhabdomyosarcoma.
- Unable or unwilling to receive gadolinium-based contrast.
- Patients who are unable or unwilling to undergo MRI studies.
- Patients who may be unlikely or unable to be able to complete 3 additional MRI studies during the course of their 5-week radiation plan in the opinion of the PI.
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 |
|---|---|---|
| MRIPatients will undergo RT therapy per SOC and will receive 3 additional MRI studies at the end of RT weeks 1, 3, and 5 with an allowable window of +/- 3 days to account for delays in radiation or unforeseeable circumstances which prevent completion of MRI such as illness or weather. | Diagnostic test | MRI studies at 3 non-SOC timepoints (end of weeks 1, 3, and 5) |
Primary outcome
Feasibility measured as the percentage of study-specific MRI scans beyond standard of care which are completed
Time frame: Treatment weeks 1, 3, and 5
1. To evaluate the feasibility of completing serial MRI studies during a course of radiation. a. Feasibility will be measured as the percentage of study-specific MRI scans beyond standard of care which are completed at the end of the study with greater than or equal to a 66% completion rate overall (not per patient) being considered feasible.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Andrew Frankart, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Sarcoma, run by Andrew Frankart 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 23 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact UCCC Clinical Trials Office (513-584-7698, cancer@uchealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility measured as the percentage of study-specific MRI scans beyond standard of care which are completed (time frame: Treatment weeks 1, 3, and 5). 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 23 Mar 2026.