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

M.D. Anderson Cancer Center

Status: Terminated

Conditions: Lung Cancer

Treatments: Other: Simulated Online Adaptive Planning; Radiation: Stereotactic MRI-guided adaptive radiotherapy-SMART

Study type: Interventional

Funder types: Other

Identifiers

NCT05609331

NCI-2022-09313 (Other Identifier)

2022-0371

Details and patient eligibility

About

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.

Full 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

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Stage I-(Simulated Online Adaptive Planning)

Experimental group

Description:

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

Treatment:

Other: Simulated Online Adaptive Planning

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

Experimental group

Description:

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

Treatment:

Radiation: Stereotactic MRI-guided adaptive radiotherapy-SMART