Stereotactic Magnetic Resonance Guided Radiation Therapy

Clinicaltrials.gov ID: NCT04115254
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 397

Conditions

Pancreas Cancer, Lung Cancer, Renal Cancer, Adrenal Metastases, Prostate Cancer, Liver Metastases, Oligoprogressive Nodal Metastases, Metachronous Nodal Metastases, Synchronous Nodal Metastases, Mesothelioma, Spine Metastases, Brain Metastases, Borderline Resectable Pancreatic Carcinoma

Summary

This is a master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer.* 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 reference to tumor control and improvement in patient reported outcome measures

Detailed Description

This research study is a feasibility study, which means it is the first-time investigators at this institution are examining this type of MR-guided radiation to treat cancer.

The U.S. Food and Drug Administration (FDA) has approved this device as a treatment option for cancer.

In this research study, the investigators are hoping to determine if adjusting radiation treatments based on daily MRI has a feasible way to deliver radiation for participants with pancreatic, lung or renal cancer.

Locations

2 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Jonathan Leeman, MD

Principal Investigator

  • Jonathan Leeman, MD

Status

  • RECRUITING

Contact Person

  • Jonathan Leeman, MD

Principal Investigator

  • Jonathan Leeman, MD

Eligibility Criteria

Inclusion Criteria:

* Participants must have a confirmed malignancy requiring stereotactic body radiation therapy. See specific disease site cohorts for more details.
* Tumor size ≤ 7cm
* Age 18 years of older.
* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
* Ability to understand and the willingness to sign a written informed consent document.
* Specific eligibility requirements for each disease site with be covered in each specific cohort.

Exclusion Criteria:

* Specific exclusion requirements for each disease site with be covered in each specific cohort
* History of allergic reactions attributed to gadolinium-based IV contrast.

-- Note: If a patient will not receive contrast, this is not applicable
* Pregnant women are excluded from this study.
* Severe claustrophobia or anxiety
* Participants who cannot undergo an MRI

Study Plan

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/Pelvis

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes

EXPERIMENTAL

SMART will be administered per each individual disease site standards

  • RADIATION:

    MR-guided Linac

    Description:

    Radiation will be delivered on an MR-guided Linear Accelerator

Outcome Measures

Primary Outcome Measures

Delivery Success Rate for SMART across multiple tumors-Phase I

Time Frame: 1 year

Tumor visualization-Phase I

Time Frame: 1 Year

Plan creation-Phase I

Time Frame: 1 Year

Rate of Improvement in Tumor Control-Phase II

Time Frame: 1 Year

Secondary Outcome Measures

Number of Patients with Acute Toxicity-Phase I

Time Frame: 90 Days

Duration of treatment-Phase 1

Time Frame: 90 Days

Number of treatment fractions-Phase1

Time Frame: 90 Days

Number of Participants with long term toxicity-Phase II

Time Frame: 365 Days

Disease Specific Survival Rate-Phase II

Time Frame: 365 Days

Overall Survival Rate-Phase II

Time Frame: 365

Timeline

  • Last Updated
    November 5, 2024
  • Start Date
    October 3, 2019
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    June 1, 2028

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