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Radiation Therapy

MRIdian® Linac for Breast Cancer (CONFIRM Trial)

N/A
Recruiting
Led By Raymond Mak, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial is testing a new cancer treatment that uses MRI to target radiation.

Who is the study for?
This trial is for adults with certain cancers (like breast, stomach, and laryngeal) who need radiation treatment. They must be able to give consent and have a performance status that allows daily activities with effort or better. People can't join if they can't have an MRI, are severely claustrophobic, anxious, or allergic to MRI contrast agents.
What is being tested?
The study tests the safety of using MRIdian Linear Accelerator guided by MRI alongside chemotherapy in treating gastric and breast cancer patients. It aims to see how well this advanced technology targets tumors during radiation therapy.
What are the potential side effects?
Potential side effects may include typical reactions from radiation such as skin irritation, fatigue, nausea; plus any discomforts related to lying still in an MRI machine like stiffness or temporary anxiety.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
1-year tumor control-Phase II
Number of Patients and delivering MR-image guided radiation-Phase I
Patient reported outcomes (PROMs) -Phase II
+2 more
Secondary study objectives
Characterizing MRI-based tumor alterations/changes following MR-image guided radiation
Duration of treatment with goal of >80% of cases treated within 90 minutes
Number of Participants with Treatment Related Adverse Events as Assessed CTCAE version 5.0.
+3 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Phase I - Mantle Cell LymphomaExperimental Treatment1 Intervention
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
Group II: Phase I - LarynxExperimental Treatment1 Intervention
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
Group III: Phase I - Gastric CancerExperimental Treatment1 Intervention
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
Group IV: Phase I - Breast CancerExperimental Treatment1 Intervention
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
Group V: Phase I - BladderExperimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,100 Previous Clinical Trials
353,027 Total Patients Enrolled
Raymond Mak, MDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
92 Total Patients Enrolled

Media Library

Viewray MRIdian® Linac (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04368702 — N/A
Stomach Cancer Research Study Groups: Phase I - Breast Cancer, Phase I - Larynx, Phase I - Bladder, Phase I - Gastric Cancer, Phase I - Mantle Cell Lymphoma
Stomach Cancer Clinical Trial 2023: Viewray MRIdian® Linac Highlights & Side Effects. Trial Name: NCT04368702 — N/A
Viewray MRIdian® Linac (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04368702 — N/A
~40 spots leftby Jun 2029
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