CClinicalTrials.gg
TerminatedNCT05609331Updated Nov 10, 2025

Feasibility, Safety, and Efficacy of Stereotactic MRI-Guided Adaptive Radiation Therapy (SMART) for Central Lung Tumors

An interventional study of Simulated Online Adaptive Planning and Stereotactic MRI-guided adaptive radiotherapy-SMART in Lung Cancer, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-10.

Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Treatment

Why this study was terminated
\<75 % participation
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Lung Cancer

Browse trials for

03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's enrollment of 3 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Stage I-(Simulated Online Adaptive Planning)

    Participants will receive treatment with the conventional CT-based radiation therapy and receive additional MRI scans.

    Other: Simulated Online Adaptive Planning

  • Experimental
    Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART)

    Participants will receive treatment with the investigational MRI-guided radiation therapy.

    Radiation: Stereotactic MRI-guided adaptive radiotherapy-SMART

Interventions

  • OtherSimulated 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

  • RadiationStereotactic 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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • M. D. Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

Study documents

  • Informed consent form · Jul 10, 2023

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05609331
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Nov 8, 2022
Start date
Nov 17, 2022
Primary completion
Nov 5, 2025
Completion
Nov 5, 2025
Last update
Nov 10, 2025

Study contacts

Saumil Gandhi, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion