Clinical trial · Interventional
Radiographic Evaluation of Tumor Biology During Neoadjuvant Radiotherapy for Sarcoma
NCT07487870CI-TRIAL-00106275not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI studies at 3 non-SOC timepoints (end of weeks 1, 3, and 5)
- description
- 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.
- interventionNames
- Diagnostic Test: MRI
Primary outcomes (1)
- measure
- Feasibility measured as the percentage of study-specific MRI scans beyond standard of care which are completed
- timeFrame
- Treatment weeks 1, 3, and 5
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.