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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Stereotactic MRI-guided adaptive radiotherapy (SMART) for lung cancer?

Research shows that using MRI in radiation therapy for lung cancer can improve the accuracy of targeting tumors, potentially leading to better treatment outcomes. Additionally, studies on similar treatments for other cancers, like pancreatic and rectal cancer, suggest that SMART can be effective in managing tumors with fewer side effects. ^{1 2 3 4 5}

Is SMART generally safe for humans?

Studies on SMART for different cancers, like rectal cancer, have looked at early side effects and found it to be manageable, suggesting it is generally safe for humans. Research on healthy volunteers also helps ensure the treatment is safe before it's used in patients. ^{1 2 5 6 7}

What makes the SMART treatment for lung cancer unique?

SMART (Stereotactic MRI-guided adaptive radiotherapy) is unique because it uses real-time MRI to precisely target lung tumors while sparing healthy tissue, allowing for higher doses of radiation to be safely delivered. This approach improves tumor control and reduces side effects compared to traditional radiation therapy. ^{1 2 8 9 10}

Research Team

Saumil Gandhi, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Age ≥ 18 years

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Stereotactic MR-guided adaptive radiotherapy (SMART) for primary rectal cancer: evaluation of early toxicity and pathological response. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic MR-guided adaptive radiation therapy for peripheral lung tumors. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Fast and robust online adaptive planning in stereotactic MR-guided adaptive radiation therapy (SMART) for pancreatic cancer. [2022]

4. China pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in precision radiation therapy for lung cancer. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Variability of Gross Tumor Volume Delineation for Stereotactic Body Radiotherapy of the Lung With Tri-60Co Magnetic Resonance Image-Guided Radiotherapy System (ViewRay): A Comparative Study With Magnetic Resonance- and Computed Tomography-Based Target Delineation. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Use of a healthy volunteer imaging program to optimize clinical implementation of stereotactic MR-guided adaptive radiotherapy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Role of On-Table Plan Adaptation in MR-Guided Ablative Radiation Therapy for Central Lung Tumors. [2019]

8. Ireland pubmed.ncbi.nlm.nih.gov

To fly or not to fly: Stereotactic MR-guided adaptive radiotherapy effectively treats ultracentral lung tumors with favorable long-term outcomes. [2023]

9. Switzerland 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. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Magnetic Resonance-Guided Adaptive and Non-Adaptive Radiotherapy on Combination MR-Linear Accelerators: Current Practice and Future Directions. [2023]