Lung Cancer Clinical Trial
Feasibility, Safety, and Efficacy of Stereotactic MRI-Guided Adaptive Radiation Therapy (SMART) for Central Lung Tumors
Summary
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.
Full Description
Primary Objective:
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
Eligibility Criteria
Stage I:
Inclusion Criteria:
Primary lung cancer or lung metastasis from another primary
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
Age ≥ 18 years
Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
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
Inability to tolerate MR imaging (Ie. history of claustrophobia)
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:
Primary lung cancer or lung metastasis from another primary
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
Age ≥ 18 years
Ability to understand and the willingness to sign a written informed consent
Determined by two thoracic radiation oncologists to require > 10-15 fraction regimens if treated with CT-based, non-adaptive radiation therapy
Exclusion Criteria:
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
Inability to tolerate MR imaging (Ie. history of claustrophobia)
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.
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There is 1 Location for this study
Houston Texas, 77030, United States More Info
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Principal Investigator
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