Clinical trial · Interventional
A Master Trial Assessing the Technical Feasibility of First-In-Human Real-Time Image Guided Radiation Therapy Methods
Real-Time IGRT: A Master Trial Assessing the Technical Feasibility of First-In-Human Real-Time Image Guided Radiation Therapy Methods
- 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)
The goal of this clinical trial is to determine whether Real-Time Image Guided Radiation Therapy is a feasible method for radiation therapy delivery for patients with cancer. The main questions it aims to answer are: * Can all fractions per patient which are intended to be delivered with the real-time IGRT method be completed as planned? * Can the beam accurately hit the tumour in ≥85% of fractions? * Are there any unexpected grade \>3 acute toxicities? Participants will not require any additional treatments or preparation procedures above those required for normal radiation therapy treatment, to participate in this study.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Real-Time Image Guided Radio Therapy (IGRT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Real-Time IGRT
- description
- Real-Time IGRT
- interventionNames
- Device: Real-Time Image Guided Radio Therapy (IGRT)
Primary outcomes (1)
- measure
- Successful application of Real-Time IGRT
- timeFrame
- From the date of enrolment until 90 days after the completion of radiotherapy treatment
- description
- Each real-time IGRT method under study is deemed feasible if successfully applied in 18 out of 20 consecutive patients (success rate of 90%), with a maximum of 40 patients to be included per cohort. If the real-time IGRT method is unsuccessfully applied in three consecutive patients or the real-time IGRT method is not successfully applied in 18 out of 20 consecutive patients after the inclusion of 40 patients, it is considered unfeasible. For each real-time IGRT method, success is defined by three general criteria (each of the three criteria should be met to reach feasibility): 1. All fractions per patient which are intended to be delivered with the real-time IGRT method are completed as planned 2. Absence of geographical miss in ≥85% of fractions or, in case of stereotactic treatments, in all minus one fraction. Geographical miss is defined as the clinical treatment volume outside the treated volume as measured on post-treatment image analysis 3. No unexpected grade \>3 acute toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients 18 years or older to be treated with curative radiation therapy * Patients with brain, breast, head and neck, kidney, liver, lung, pancreas, prostate or spine cancer * ECOG performance status 0-2 * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Pregnancy, * Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements or severe psychiatric illness/social situation * Additional inclusion and exclusion criteria may apply to a specific sub-study
References
Publications (0)
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