Radiographic Evaluation of Tumor Biology During Neoadjuvant Radiotherapy for Sarcoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI.
- Who it may be relevant to
- Registry conditions: Sarcoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test MRI
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.
Primary outcome measures
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Cincinnati Medical Center — Cincinnati
Identifiers
NCT: NCT07487870 · UCCC-RT-25-06