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

November 6, 2025 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study
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
The results of the MRI-guided radiation therapy will be compared to conventional radiation therapy (guided by CT scans) during this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Saumil Gandhi, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2022

Primary Completion (Actual)

November 5, 2025

Study Completion (Actual)

November 5, 2025

Study Registration Dates

First Submitted

October 28, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Estimated)

November 10, 2025

Last Update Submitted That Met QC Criteria

November 6, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0371
  • NCI-2022-09313 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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