Lung CancerNCT05609331
Feasibility, Safety, and Efficacy of Stereotactic MRI-Guided Adaptive Radiation Therapy (SMART) for Central Lung Tumors
A study testing Simulated Online Adaptive Planning and Stereotactic MRI-guided adaptive radiotherapy-SMART in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Simulated Online Adaptive Planning and Stereotactic MRI-guided adaptive radiotherapy-SMART
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2022to 5 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Lung Cancer
- Being tested
- Simulated Online Adaptive Planning, Stereotactic MRI-guided adaptive radiotherapy-SMART
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated Online Adaptive PlanningOther
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-SMARTRadiation
The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study
| Study group | Role | What they receive |
|---|---|---|
| Stage I-(Simulated Online Adaptive Planning) | Experimental | Participants will receive treatment with the conventional CT-based radiation therapy and receive additional MRI scans. Receives: Other: Simulated Online Adaptive Planning |
| Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART) | Experimental | Participants will receive treatment with the investigational MRI-guided radiation therapy. Receives: Radiation: Stereotactic MRI-guided adaptive radiotherapy-SMART |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start17 Nov 2022
- Primary completion5 Nov 2025
- Study completion5 Nov 2025
Why it stopped: \<75 % participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saumil Gandhi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609331
- Sponsor's protocol ID
- 2022-0371
- Other IDs
- NCI-2022-09313
- Status last verified
- Nov 2025
- First submitted
- 28 Oct 2022
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety, and Efficacy of Stereotactic MRI-Guided Adaptive Radiation Therapy (SMART) for Central Lung Tumors
- ClinicalTrials.gov ID
- NCT05609331
- Acronym / sponsor ID
- 2022-0371
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \<75 % participation
- Enrolment
- 3 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage I-(Simulated Online Adaptive Planning) | Experimental | Other: Simulated Online Adaptive PlanningParticipants will receive treatment with the conventional CT-based radiation therapy and receive additional MRI scans. |
| Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART) | Experimental | Radiation: Stereotactic MRI-guided adaptive radiotherapy-SMARTParticipants will receive treatment with the investigational MRI-guided radiation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Primary lung cancer or lung metastasis from another primary
Key exclusion criteria (7 listed)
- 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.
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulated Online Adaptive PlanningThe results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study | Other | Stage I-(Simulated Online Adaptive Planning) |
| Stereotactic MRI-guided adaptive radiotherapy-SMARTThe results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study | Radiation | Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART) |
Primary outcome
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
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: \<75 % participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- M. D. Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saumil Gandhi, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulated Online Adaptive Planning and Stereotactic MRI-guided adaptive radiotherapy-SMART in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: \<75 % participation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.