SMART for Lung Cancer

Overseen By Saumil Gandhi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Metallic implants, Claustrophobia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to guide radiation therapy for individuals with central lung cancer. It aims to determine if MRI (a detailed imaging technique) can guide radiation treatment more effectively than the usual CT scans. The trial includes two groups: one will receive standard CT-guided radiation with additional MRI scans, while the other will undergo the new MRI-guided treatment, known as Stereotactic MRI-guided Adaptive Radiotherapy (SMART). Suitable candidates have primary lung cancer or cancer that has spread to the lungs, with tumors near critical areas like the heart or major blood vessels. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that MRI-guided radiation therapy is safe for treating central lung cancer?

Research has shown that stereotactic MRI-guided adaptive radiotherapy (SMART) is safe. In earlier studies, SMART effectively controlled central lung cancer and proved safe for patients. Participants tolerated the treatment well, with results comparable to traditional methods. These studies found no significant increase in side effects compared to other radiation therapies, indicating that SMART is generally well-tolerated by lung cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stereotactic MRI-guided adaptive radiotherapy, or SMART, because it offers a more precise method for treating lung cancer compared to conventional CT-based radiation therapy. Unlike standard treatments that rely on CT scans, SMART uses real-time MRI imaging to adapt radiation doses on the fly, potentially improving accuracy and sparing healthy tissue. This dynamic adjustment can lead to fewer side effects and better outcomes for patients. By incorporating advanced MRI technology, SMART represents a significant step forward in personalized cancer treatment.

What evidence suggests that MRI-guided radiation therapy is effective for controlling lung cancer?

Research shows that using MRI (magnetic resonance imaging) to guide radiation therapy for lung cancer, known as SMART, is promising. In this trial, participants in one arm will receive the investigational MRI-guided radiation therapy, SMART. Studies have found that SMART can accurately target tumors while protecting healthy tissue, which is crucial in lung cancer treatment. Specifically, one study reported that SMART effectively controlled 54 lung tumors treated between 2016 and 2018. Early results suggest that SMART is both safe and effective, potentially leading to better outcomes than traditional CT (computed tomography)-guided radiation. This method may offer a new way to treat lung cancer by allowing for more precise delivery of radiation. ^{1 4 5 6 7}

Who Is on the Research Team?

Saumil Gandhi, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with central lung tumors close to critical structures who can sign consent. It's for those needing more than 10-15 radiation sessions if using CT-based therapy, and includes primary or metastatic lung cancer patients. Pregnant women, individuals unable to undergo MRI due to claustrophobia or metal implants, and those not using contraception are excluded.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent

The tumor is located very close to important structures in the chest.

Two doctors specializing in chest radiation agree that you need to receive radiation treatments in more than 10-15 sessions using a specific type of radiation therapy.

Exclusion Criteria

You can't handle being in a tight space for an MRI scan, for example, if you have claustrophobia.

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage I: Simulated Online Adaptive Planning

Participants receive treatment with conventional CT-based radiation therapy and additional MRI scans to assess feasibility of SMART

4-5 weeks

Stage II: Stereotactic MRI-guided Adaptive Radiotherapy (SMART)

Participants receive investigational MRI-guided radiation therapy with 50Gy in 4-5 fractions to evaluate feasibility, safety, and efficacy

4-5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic MRI-guided adaptive radiotherapy-SMART

Trial Overview The study tests Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) against conventional CT-guided therapy in controlling central lung cancer. The goal is to see if MRI guidance improves treatment precision and effectiveness compared to the usual method.

How Is the Trial Designed?

Group I: Stage II (Stereotactic MRI-guided adaptive radiotherapy-SMART) Experimental Treatment 1 Intervention

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

Group II: Stage I-(Simulated Online Adaptive Planning) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

The SMART3CM strategy for adaptive radiation therapy in locally advanced pancreatic cancer significantly reduces the number of required optimizations (4 vs 18) compared to the standard FULLOAR method, while maintaining equivalent target coverage (mean V95%=89%).

Using SMART3CM results in lower doses to surrounding organs at risk (OARs) and better adherence to dose constraints, demonstrating its efficacy in sparing healthy tissue during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fast and robust online adaptive planning in stereotactic MR-guided adaptive radiation therapy (SMART) for pancreatic cancer. Bohoudi, O., Bruynzeel, AME., Senan, S., et al.[2022]

Stereotactic MR-guided adaptive radiotherapy (SMART) for pancreatic tumors showed no patients experiencing severe acute toxicities, with the most common side effects being mild (grade 1-2) symptoms like asthenia and nausea.

The study demonstrated promising outcomes with a median overall survival of 14.1 months and high local control rates (97% at 6 months), indicating that SMART is effective and safe for treating pancreatic tumors, with a notable secondary surgical resection rate in patients initially diagnosed with locally advanced pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic MR-Guided Radiotherapy for Pancreatic Tumors: Dosimetric Benefit of Adaptation and First Clinical Results in a Prospective Registry Study. Michalet, M., Bordeau, K., Cantaloube, M., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2452109425001939

Safety and Efficacy of Stereotactic MR-Guided Adaptive ... This retrospective study analyzed outcomes of SMART-based SABR for ultracentral metastatic lesions in patients with histologically confirmed non ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11311467/

Harnessing the Power of Radiotherapy for Lung Cancer Current clinical trial results support the use of stereotactic MR-guided adaptive radiation therapy (SMART) in treating CLTs/ULTs. Regnery et al ...

3. redjournal.org redjournal.org/article/S0360-3016(20)30249-2/abstract

Clinical Outcomes of Stereotactic MR-Guided Adaptive ... Fifty consecutive patients (54 lung tumors) underwent SMART between 2016 and 2018 for either a primary lung cancer (29 patients) or for lung ...

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1622060/full

Recent technical advancements and clinical applications of ... This review explores the latest technological advancements, clinical applications, and emerging trends in MRgRT for lung cancer treatment.

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00121-X/fulltext

Efficacy and safety of online adaptive magnetic resonance- ... This study aimed to evaluate the efficacy and safety of online adaptive MR-guided fractionated stereotactic radiotherapy (FSRT) using a 1.5 T MR-Linac in this ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6349650/

Stereotactic MR-Guided Online Adaptive Radiation Therapy ... A collaborative analysis of stereotactic lung radiotherapy outcomes for early-stage non-small-cell lung cancer using daily online cone beam computed ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04115254

Stereotactic Magnetic Resonance Guided Radiation Therapy The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer. Phase 2 will evaluate efficacy of SMART with specific ...