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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05609331
• Other study ID #: 2022-0371
• Secondary ID: NCI-2022-09313
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: January 7, 2026

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: Saumil Gandhi, MD
• Phone: (713) 563-7775
• Email: sngandhi[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 7, 2026
• Est. primary completion date: January 7, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
United States	M. D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M. D. Anderson Cancer Center