Clinical trial · Interventional
Feasibility, Safety, and Efficacy of Stereotactic MRI-Guided Adaptive Radiation Therapy (SMART) for Central Lung Tumors
NCT05609331CI-TRIAL-00097128terminatedN/AClinicalTrials.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): \<75 % participation
Summary
Brief summary (as posted)
To learn if using MRI (magnetic resonance imaging) to guide radiation therapy can help to control central lung cancer. The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during 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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Simulated Online Adaptive Planning | Other | — | UNRESOLVED |
| Stereotactic MRI-guided adaptive radiotherapy-SMART | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stage I-(Simulated Online Adaptive Planning)
- description
- Participants will receive treatment with the conventional CT-based radiation therapy and receive additional MRI scans.
- interventionNames
- Other: Simulated Online Adaptive Planning
- type
- EXPERIMENTAL
- label
- Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART)
- description
- Participants will receive treatment with the investigational MRI-guided radiation therapy.
- interventionNames
- Radiation: Stereotactic MRI-guided adaptive radiotherapy-SMART
Primary outcomes (1)
- measure
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Stage I: Inclusion Criteria: 1. Primary lung cancer or lung metastasis from another primary 2. Central tumors ≤ 2 cm from any mediastinal critical structure (proximal bronchial tree, esophagus, heart, brachial plexus, major vessels, spinal cord, phrenic nerve, and recurrent laryngeal nerve 3. Age ≥ 18 years 4. Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: 1. Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators, stimulators, pacemakers, or neurotransmitters) per institutional policy on management of patients with internal and external medical devices 2. Inability to tolerate MR imaging (Ie. history of claustrophobia) 3. Women who are pregnant. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Stage 2: Inclusion Criteria: 1. Primary lung cancer or lung metastasis from another primary 2. Central tumors ≤ 2 cm from any mediastinal critical structure (proximal bronchial tree, esophagus, heart, brachial plexus, major vessels, spinal cord, phrenic nerve, and recurrent laryngeal nerve 3. Age ≥ 18 years 4. Ability to understand and the willingness to sign a written informed consent 5. Determined by two thoracic radiation oncologists to require \> 10-15 fraction regimens if treated with CT-based, non-adaptive radiation therapy Exclusion Criteria: 1. Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators, stimulators, pacemakers, or neurotransmitters) per institutional policy on management of patients with internal and external medical devices 2. Inability to tolerate MR imaging (Ie. history of claustrophobia) 3. Women who are pregnant. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
References
Publications (0)
Data not yet available
No reference posted for this study.