Sarcoma
Conditions
Brief 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.
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_TESTMRI
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.
Sponsors
Andrew Frankart
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must have histologically or cytologically confirmed history of soft tissue sarcoma. 2. Plan to receive neoadjuvant radiation to a dose of 50 Gy in 25 fractions followed by surgical resection per Investigator. 3. Age ≥18 years. 4. ECOG performance status ≤2.
Exclusion criteria
1. Patients with Ewing's sarcoma and rhabdomyosarcoma. 2. Unable or unwilling to receive gadolinium-based contrast. 3. Patients who are unable or unwilling to undergo MRI studies. 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility measured as the percentage of study-specific MRI scans beyond standard of care which are completed | 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. |
Countries
United States
Contacts
CONTACTUCCC Clinical Trials Office
CONTACTAndrew Frankart, MD
Outcome results
None listed