Clinical trial · Observational
Respiratory Tumor and Normal Tissue Motion
Assessing the Magnitude and Potential Impact of Respiration-Induced Three-Dimensional Motion of Tumors and Normal Tissues Using Four-Dimensional CT Technology
- 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)
Primary Objectives: * To collect accurate and reliable respiration-induced anatomic structure motion data using four-dimensional (4-D) imaging technology. * To analyze these data to study respiration-induced variations and patterns in variations of positions, shapes and volumes of tumors and normal anatomic structures in the thorax and abdomen over a breathing cycle, from one breathing cycle to the next, day-to-day and over the course of radiotherapy. * To assess dosimetric and potential clinical consequences of respiratory motion in the current practice of radiotherapy through preclinical treatment simulation (treatment planning) studies. * To quantify the potential consequences of explicitly accounting for respiration-induced motion on dose distributions and outcome (tumor control probabilities and normal tissue complication probabilities) through preclinical treatment simulation studies. Secondary Objectives: * To investigate the feasibility of using patient training to regulate patient breathing and improve the quality of images and to stratify patients for their eligibility for respiratory-correlated imaging and radiotherapy and for the implementation of various strategies for mitigation of respiratory-induced motion. * To assess the degree of correlation of the marker (or internal anatomic structure such as diaphragm) being tracked as surrogate of breathing with the motion of structures and the intra-fraction and inter-fraction reproducibility of such correlation. * To quantify the effects of radiation therapy on the patterns of respiratory-induced motion of structures through preclinical treatment simulation studies. * To compare various strategies for either accounting for or mitigating respiration-induced motion in the planning and delivery of radiation therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Cancer | Malignant Abdominal Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Motion CT Scans | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Respiratory Tumor + Normal Tissue Motion
- interventionNames
- Procedure: Motion CT Scans
Primary outcomes (1)
- measure
- Indices of Respiration-induced Anatomic Structure Motion, Structure Volume + Structure Shape Changes
- timeFrame
- 3 Years Data Collection: Up to 12 scanning sessions per patient from baseline to completion of radiotherapy (minimally 4 week treatment)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients with pathological diagnosis of cancer in the thorax or abdomen. 2. Patients must be planned to have radiation therapy delivered over at least 4 weeks (a minimum standard duration of curative radiotherapy). 3. Patients must be able to lie flat for the duration of the CT image acquisition sessions. Exclusion Criteria: 1\. Patients who are neither able to breathe nor hold breath in a regular and reproducible manner will be removed from the study as being ineligible. Breathing or breath-holding regularity determination will be based on respiration traces acquired with the RPM system.
References
Publications (0)
Data not yet available