Clinical trial · Interventional
Cone Beam Computed Tomography (CT) (CBCT) With and Without a Customized Vacuum Immobilization Device (CVID)
A Randomized Study Evaluating Set-up Reproducibility Using Cone Beam CT (CBCT) With and Without a Customized Vacuum Immobilization Device (CVID) in Rectal Cancer Patients Treated With Preoperative Pelvic Radiation Therapy
- 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 study is designed to investigate whether or not the use of a customized vacuum immobilization device (CVID) to immobilize rectal cancer patients undergoing preoperative pelvic radiation therapy improves the positional stability of patients during each radiation treatment. This question is more relevant now in the era of image-guided radiation therapy (IGRT). Using state of the art IGRT technologies such as cone beam CT (CBCT) scanning, assessments of the accuracy of treatment delivery can be made during a course of radiation therapy allowing for patient set-up corrective strategies to be implemented. The use of CBCT scanning may minimize any potential benefit of of a CVID if the patient's pretreatment position can be corrected prior to treatment and our current immobilization strategy results in a stable patient position. While it is seemingly intuitive to assume that the use of CVID results in better patient stability, there is actually little data to support this.
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Customized Vacuum Immobilization Device (CVID) | Device | — | UNRESOLVED |
| prone pillow and simple ankle fixation device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional
- description
- Patient randomized to be immobilized using a prone pillow and simple ankle fixation device with a CVID.
- interventionNames
- Device: Customized Vacuum Immobilization Device (CVID)
- type
- ACTIVE_COMPARATOR
- label
- Standard Arm
- description
- Patient randomized to be immobilized using a prone pillow and simple ankle fixation device without a CVID
- interventionNames
- Device: prone pillow and simple ankle fixation device
Primary outcomes (1)
- measure
- Comparing the use of a prone pillow and simple ankle fixation device vs. the use of a CVID for immobilization rectal patients during the course of preoperative radiation therapy using KV CBCT for IGRT.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any rectal cancer patient who is to receive a 5 week course of preoperative pelvic radiation therapy with or without concurrent chemotherapy * Prone treatment position * Age 18 years or older * Informed consent Exclusion Criteria: * Inability to provide informed consent * Inability to tolerate treatment in the prone position * Pregnancy * Patients with unilateral or bilateral metallic total hip replacements
References
Publications (0)
Data not yet available