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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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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 moreSecondary 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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,108 Previous Clinical Trials
356,968 Total Patients Enrolled
Raymond Mak, MDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
92 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are unable to have an MRI.There may be additional criteria for exclusion related to your specific disease.If you are not going to receive a contrast, your kidney function will not affect your eligibility.You have severe fear of enclosed spaces or anxiety disorders.Additional rules may apply depending on the specific disease being studied.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I - Breast Cancer
- Group 2: Phase I - Larynx
- Group 3: Phase I - Bladder
- Group 4: Phase I - Gastric Cancer
- Group 5: Phase I - Mantle Cell Lymphoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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