Clinical trial · Interventional
Pilot Study: Dynamic Contrast-enhanced Magnetic Resonance Imaging(DCE-MRI)for Assessing Tumor Vascularity and Permeability in Soft Tissue Sarcoma Treated With Preoperative Radiotherapy Followed by Surgical Resection
NCT01575951CI-TRIAL-00044794completedN/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 pilot study to determine the diagnostic value of dynamic contrast enhancing MRI (DCE-MRI) in soft tissue sarcoma for assessment of tumor radiographic changes in vascular permeability and microvessel density before and after preoperative radiotherapy.
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 |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI-DCE | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All patients
- description
- All participants enrolled.
- interventionNames
- Radiation: MRI-DCE
Primary outcomes (1)
- measure
- Feasibility
- timeFrame
- 36 months
- description
- Feasibility of DCE-MRI (Dynamic contrast-enhancing) in adult soft tissue sarcoma
Secondary outcomes (2)
- measure
- Necrosis level
- timeFrame
- 36 months
- description
- We will measure necrosis within the ROI (region of interest).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically confirmed soft tissue sarcoma. 2. Age ≥ 18. 3. ECOG 0-1. 4. Able to receive preoperative radiotherapy followed by surgical resection. 5. Able to provide treatment consent forms that conforms to federal and institutional guidelines. 6. Have adequate kidney function for safe administration of gadolinium contrast, as determined by current Department of Radiology MRI guidelines. 7. Creatinine clearance either by 24 hour collection or nomogram: Creatinine clearance (CC) \> 50 ml/min is determined by 24 hour collection or nomogram: CC male = (140 - age) x (wt. in kg)/(Serum Cr mg/dl) x 72 CC female = 0.85 x (CC male) Exclusion Criteria: 1. Patients have claustrophobia, iron or metal in the MRI scan site or pacemaker which are contraindicated for MRI scan. 2. patients have pacemaker or defibrillator and contraindicated to MRI images 3. Patients are allergic to gadolinium IV contrast. 4. Patients have acute or chronic renal insufficiency and contraindicated to gadolinium contrast enhancing MRI. 5. Patient had previous radiation to the same disease site. 6. Patient had chemotherapy prior to preoperative radiotherapy. 7. Patients that are pregnant. Patients that may become pregnant must have a negative pregnancy test prior to enrolling.
References
Publications (0)
Data not yet available
No reference posted for this study.