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NCT Number: NCT04368702

CONFIRM: Magnetic Resonance Guided Radiation Therapy

This research is being done to determine the safety and feasibility of using a type of radiation guided by magnetic resonance imaging (MRI) and chemotherapy to treat patients with gastric and breast cancer. The name of the radiation machine involved in this study is the MRIdian Linear Accelerator.

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Key information

Conditions

Gastric Cancer Bladder Cancer Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders In Situ Breast Cancer Invasive Breast Cancer Laryngeal Diseases Laryngeal Neoplasms Larynx Cancer Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Mantle Cell Lymphoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham & Women's Hospital, Boston, Massachusetts, United States

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About this study

This is a master clinical protocol evaluating magnetic resonance (MR) image guided radiation in patients with gastric and breast cancer.

In this research study, the investigators are researching if getting an MRI during radiation is a feasible way to delivery radiation. In this research study, a MRI done during treatment will help doctors adapt the radiation to target the most precise spot where the cancer is located.

The research study procedures include:

  • Screening for eligibility
  • Study treatment including evaluations
  • Follow up visits
  • Questionnaires

This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of investigational radiation treatment and also tries to define the appropriate dose of the investigational radiation treatment to use for further studies. "Investigational" means that the way the radiation treatment is delivered is being studied.

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. Investigators at other hospitals and academic centers are already using this type of radiation.

The U.S. Food and Drug Administration (FDA) has approved this radiation machine and these drugs as treatment options for gastric and breast cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have histologically or cytologically confirmed malignancy requiring radiation
  • 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.
  • Any further criteria listed in the specific disease site cohort

Exclusion criteria

  • History of allergic reactions attributed to gadolinium-based IV contrast

-- Note: If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility

  • Severe claustrophobia or anxiety
  • Participants who cannot undergo an MRI
  • Any other exclusion criteria listed in the specific disease site cohort

Treatment and study plan

Viewray MRIdian® Linac

Radiation

MR-image guided radiation will be administered per disease site standards.

Primary outcomes

  1. Number of Patients and delivering MR-image guided radiation-Phase I

    Time frame: 5 weeks

    Master feasibility study evaluating MR-image guided radiation. Feasibility is defined as Enrolling patients and delivering MR-image guided radiation on the MR Linac

  2. Tumor Assessment with MR Guidance-Phase I

    Time frame: 5 weeks

    Master feasibility study evaluating MR-image guided radiation. Feasibility is defined as assessing tumor using MR guidance before, during and after MR-guided treatment patient.

  3. Patient reported outcomes (PROMs) -Phase II

    Time frame: 1 year

    PROMs are collected at patient visits. PROMs will be evaluated using the Patient-Reported Outcomes Measurement Information System (PROMIS). The PROMIS Global-10 metric collects information on symptoms and quality of life.

  4. 1-year tumor control-Phase II

    Time frame: 1 year

    Tumor response 1 year after radiation treatment

  5. Rate of Pathologic complete response-Gastric

    Time frame: 1 year

    full pathological review of surgical specimen according to the AJCC Staging Classification, 8th edition. pCR will be defined as the absence of any viable tumor cells within the pathologic specimen.

Secondary outcomes

  1. Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.

    Time frame: 90 Days

    Toxicity of MRgRT with concurrent chemotherapy will be summarized by category and grade according to CTCAE version 5.0.

  2. Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.

    Time frame: 1 year

    CTCAE version 5.0.

  3. Duration of treatment with goal of >80% of cases treated within 90 minutes

    Time frame: 7 weeks

    Total time of treatment for each fraction

  4. Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without MR-image guided radiation.

    Time frame: 5 Weeks

    Importance of MR-guidance

  5. Progression Free Survival

    Time frame: irst date of protocol therapy to the earliest date of disease progression per RECIST criteria or death due to any cause up to 12 Months

    Estimated using the Kaplan Meier method with 95% confidence intervals based on the complementary log-log transformation.

  6. Overall Survival

    Time frame: irst date of protocol therapy to the date of death due to any cause. OS time will be censored at the date of last follow-up for patients still alive up to 1 year

    The OS rate will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.

  7. Characterizing MRI-based tumor alterations/changes following MR-image guided radiation

    Time frame: 1 Year

    Evaluation of tumor response following treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Raymond Mak, MD

CONTACT

[email protected]

6177328651

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol

Acronym: CONFIRM

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Apr 30, 2020
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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