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

Not Applicable

Active, not recruiting

• Conditions: Lung Cancer
• Interventions: Radiation: Stereotactic MRI-guided adaptive radiotherapy-SMART; Other: Simulated Online Adaptive Planning

• Registration Number: NCT05609331
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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

Study Timeline

• Study First Submitted: 2022-10-28
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-08
• Study Start: 2022-11-17
• Status Verified: 2024-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-05
• Primary Completion: 2026-01-07
• Study Completion: 2026-01-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART)	Stereotactic MRI-guided adaptive radiotherapy-SMART	Participants will receive treatment with the investigational MRI-guided radiation therapy.
Stage I-(Simulated Online Adaptive Planning)	Simulated Online Adaptive Planning	Participants will receive treatment with the conventional CT-based radiation therapy and receive additional MRI scans.

Primary Outcome Measures

Name	Time	Method
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	through study completion, an average of 1 year

Trial Locations

Locations (1)

M. D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States