Clinical trial · Observational
Real-time Tumor Localization and Guidance for Radiotherapy Using Ultrasound (US) and Magnetic Resonance (MR)
NCT04095091CI-TRIAL-00070947terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Device to be used in study is no longer available
Summary
Brief summary (as posted)
The primary objective of this protocol is to evaluate the feasibility of acquiring simultaneous 4D ultrasound and 4D MRI scans. The imaging performance of the US and MRI scans will be characterized. The secondary objective of this study is to determine if several salient features identified in the US scan can be used to predict target motion identified in the MR scan.
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 |
|---|---|---|---|
| Tumor, Solid | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4D Planar US Transducer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control Group
- description
- Healthy volunteers will be asked to complete a single imaging session that will include acquiring simultaneous 4D ultrasound and 4D MRI scan. A substudy including patients undergoing radiotherapy for malignancies of the abdomen and pelvis. They will also be asked to complete a single imaging session that will include acquiring simultaneous 4D ultrasound and 4D MRI scan.
- interventionNames
- Device: 4D Planar US Transducer
- label
- Patient Group
- description
- Patients receiving radiotherapy for malignancies of the abdomen and pelvis will be asked to complete two research visits lasting approximately one hour. Each visit will include a 30 minute combined 4D ultrasound and 4D MRI scan.
- interventionNames
- Device: 4D Planar US Transducer
Primary outcomes (2)
- measure
- Feasibility testing
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (Healthy Volunteers): * Must be eighteen (18) years of age or older. * Must be able to provide informed consent. Inclusion Criteria (Patients): * Patients diagnosed with malignancies of the liver. Exclusion Criteria (All): * Under the age of eighteen (18) years. * BMI exceeds the size of the bore of the MRI scanner. * Unable or unwilling to provide informed consent. * Contraindications, as described in the volunteer consent form, to MR or US scanning such as but not limited to accidental or implanted ferrous metal and/or implanted devices whose function can be disturbed by the main magnetic field, gradient magnetic fields, or radiofrequency energy. * Women who are pregnant, suspect they might be pregnant or breastfeeding.
References
Publications (0)
Data not yet available
No reference posted for this study.