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Radiation Therapy
MRIdian® Linac for Breast Cancer (CONFIRM Trial)
N/A
Waitlist Available
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
CONFIRM Trial Summary
This trial is testing a new cancer treatment that uses MRI to target radiation.
Eligible Conditions
- Stomach Cancer
- Breast Cancer
- Mantle Cell Lymphoma
- Laryngeal Cancer
- Bladder Cancer
CONFIRM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreCONFIRM 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
1,079 Previous Clinical Trials
340,878 Total Patients Enrolled
Raymond Mak, MDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
92 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this experiment currently open?
"Affirmative. Clinicaltrials.gov hosts information that reveals this medical trial, first posted on May 1st 2021, is actively seeking participants. The research team hopes to recruit 70 patients from 2 locations for their study."
Answered by AI
What are the aims of this research endeavor?
"This clinical trial will assess the primary outcome of Tumor Assessment with MR Guidance-Phase I across 5 weeks. The secondary outcomes are Progression Free Survival, Overall Survival, and Characterizing MRI-based tumor alterations/changes following MR-image guided radiation; all these metrics can be estimated using Kaplan Meier estimations and 95% confidence intervals based on complementary log-log transformations."
Answered by AI
How many individuals are being accepted for participation in this trial?
"Affirmative. According to clinicaltrials.gov, the trial posted on May 1st 2021 is still recruiting patients and was recently updated on July 4th 2022. 70 participants need to be enrolled from two different sites."
Answered by AI
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