CONFIRM: Magnetic Resonance Guided Radiation Therapy

NCT04368702 | Recruiting DMC FDA Device

• 1 other identifier: 19-665
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Gastric Cancer; Invasive Breast Cancer; in Situ Breast Cancer; Mantle Cell Lymphoma; Larynx Cancer; Bladder Cancer

Keywords

Gastric Cancer; Invasive Breast Cancer; in Situ Breast Cancer; Lymphoma; Larynx; Bladder

Outcome Measures

Primary Outcomes (5)

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

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

  5 weeks

• Tumor Assessment with MR Guidance-Phase I

  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.

  5 weeks

• Patient reported outcomes (PROMs) -Phase II

  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.

  1 year

• 1-year tumor control-Phase II

  Tumor response 1 year after radiation treatment

  1 year

• Rate of Pathologic complete response-Gastric

  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.

  1 year

Secondary Outcomes (7)

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

  90 Days

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

  1 year

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

  7 weeks

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

  5 Weeks

• Progression Free Survival

  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

Study Arms (5)

Phase I - Gastric Cancer

EXPERIMENTAL

The research study procedures include: * Screening for eligibility * Study treatment including evaluations * MR-image guided radiation will be administered per disease site standards. * Follow up visits * Questionnaires

Radiation: Viewray MRIdian® Linac

Phase I - Breast Cancer

EXPERIMENTAL

The research study procedures include: * Screening for eligibility * Study treatment including evaluations * MR-image guided radiation will be administered per disease site standards. * Follow up visits * Questionnaires

Radiation: Viewray MRIdian® Linac

Phase I - Mantle Cell Lymphoma

EXPERIMENTAL

The research study procedures include: * Screening for eligibility * Study treatment including evaluations * MR-image guided radiation will be administered per disease site standards. * Follow up visits * Questionnaires

Radiation: Viewray MRIdian® Linac

Phase I - Larynx

EXPERIMENTAL

The research study procedures include: * Screening for eligibility * Study treatment including evaluations * MR-image guided radiation will be administered per disease site standards. * Follow up visits * Questionnaires

Radiation: Viewray MRIdian® Linac

Phase I - Bladder

EXPERIMENTAL

The research study procedures include: * Screening for eligibility * Study treatment including evaluations * MR-image guided radiation will be administered per disease site standards. * Follow up visits * Questionnaires

Radiation: Viewray MRIdian® Linac

Interventions

Viewray MRIdian® Linac RADIATION

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

Phase I - Bladder; Phase I - Breast Cancer; Phase I - Gastric Cancer; Phase I - Larynx; Phase I - Mantle Cell Lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (2)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Breast Carcinoma In Situ; Lymphoma, Mantle-Cell; Laryngeal Neoplasms; Urinary Bladder Neoplasms; Lymphoma; Laryngeal Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Raymond Mak, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Mak, MD

CONTACT

6177328651; rmak@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 30, 2020
• Study Start: May 1, 2021
• Primary Completion (Estimated): June 18, 2029
• Study Completion (Estimated): June 18, 2029
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (2)