Feasibility, Safety, and Efficacy of Stereotactic MRI-Guided Adaptive Radiation Therapy (SMART) for Central Lung Tumors
NCT ID: NCT05609331
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2022-11-17
2025-11-05
Brief Summary
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Detailed Description
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Stage I: Assess the feasibility of SMART for central lung tumors with simulated online adaptive planning.
Stage II: Evaluate the feasibility and safety of SMART in central lung tumors treated with 50Gy in 4-5 fractions.
Secondary Objectives:
Stage I: Determine clinical features that predict for greater benefit from adaptive planning Stage I: Determine the potential dosimetric benefit of SMART for central lung tumor Stage II: Determine the safety and efficacy of SMART for central lung tumors treated with 50Gy in 4-5 fractions.
Exploratory objectives:
Validate cine imaging and motion management strategies on the MR-linac
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Stage I-(Simulated Online Adaptive Planning)
Participants will receive treatment with the conventional CT-based radiation therapy and receive additional MRI scans.
Simulated Online Adaptive Planning
The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study
Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART)
Participants will receive treatment with the investigational MRI-guided radiation therapy.
Stereotactic MRI-guided adaptive radiotherapy-SMART
The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study
Interventions
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Simulated Online Adaptive Planning
The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study
Stereotactic MRI-guided adaptive radiotherapy-SMART
The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study
Eligibility Criteria
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Inclusion Criteria
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
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
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:
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.
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Saumil Gandhi, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M. D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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M. D. Anderson Cancer Center
Other Identifiers
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NCI-2022-09313
Identifier Type: OTHER
Identifier Source: secondary_id
2022-0371
Identifier Type: -
Identifier Source: org_study_id