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Trial Title:
Feasibility, Safety, and Efficacy of Stereotactic MRI-Guided Adaptive Radiation Therapy (SMART) for Central Lung Tumors
NCT ID:
NCT05609331
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Simulated Online Adaptive Planning
Description:
The results of the MRI-guided radiation therapy will be compared to conventional
radiation therapy (guided by CT scans) during this study
Arm group label:
Stage I-(Simulated Online Adaptive Planning)
Intervention type:
Radiation
Intervention name:
Stereotactic MRI-guided adaptive radiotherapy-SMART
Description:
The results of the MRI-guided radiation therapy will be compared to conventional
radiation therapy (guided by CT scans) during this study
Arm group label:
Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART)
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.
Detailed 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
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M. D. Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Start date:
November 17, 2022
Completion date:
January 7, 2026
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05609331
http://www.mdanderson.org
