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MRI-Guided Radiation Therapy for Breast Cancer (PPI Trial)

N/A

Recruiting

Led By John Ng, M.D.

Research Sponsored by Weill Medical College of Cornell University

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 120 months

Awards & highlights

PPI Trial Summary

This trial is researching if MRI-guided radiation therapy is comparable to current standard treatment for breast radiotherapy in prone position.

Who is the study for?

This trial is for women over 50 with early-stage breast cancer (DCIS or Stage I) who've had a lumpectomy with clear margins. It's not for those who've had radiation on the same breast before, can't have an MRI, are more than 90 days post-surgery without chemo, or more than 60 days post-chemo.Check my eligibility

What is being tested?

The study compares two types of radiation therapy after breast-conserving surgery: standard CT-guided treatment and a new MRI-guided method called Precision Prone Irradiation (PPI), to see if they're equally effective at controlling cancer after two years.See study design

What are the potential side effects?

Radiation therapy may cause skin irritation, fatigue, swelling in the treated area, and changes in breast texture. The side effects from MRI-guided PPI are expected to be similar but will be studied for any differences.

PPI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~120 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Comparing clinical and planning target volumes (CTV and PTV volumes) for CT-based planning vs. MRI-based planning

Comparing local recurrence rates between patients receiving Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)

Comparing number of participants with local recurrence between patients treated on Standard CT radiation therapy (ARM1) and MRI-based radiation therapy (ARM 2)

+3 more

PPI Trial Design

2Treatment groups

Active Control

Group I: ARM 1 - CT-based breast radiation treatmentActive Control1 Intervention

Patients randomized to ARM 1 will receive 3000 cGy in 5 fractions partial breast radiotherapy with CT-based breast radiation treatment.

Group II: ARM 2 - MRI-based breast radiation treatmentActive Control1 Intervention

Patients randomized to ARM 2 will receive 3000 cGy in 5 fractions partial breast radiotherapy with MRI-based breast radiation treatment.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,315,915 Total Patients Enrolled

29 Trials studying Breast Cancer

26,802 Patients Enrolled for Breast Cancer

John Ng, M.D.Principal InvestigatorWeill Medical College of Cornell University

1 Previous Clinical Trials

60 Total Patients Enrolled

1 Trials studying Breast Cancer

60 Patients Enrolled for Breast Cancer

Media Library

CT-guided Breast Irradiation Clinical Trial Eligibility Overview. Trial Name: NCT05731791 — N/A

Breast Cancer Research Study Groups: ARM 1 - CT-based breast radiation treatment, ARM 2 - MRI-based breast radiation treatment

Breast Cancer Clinical Trial 2023: CT-guided Breast Irradiation Highlights & Side Effects. Trial Name: NCT05731791 — N/A

CT-guided Breast Irradiation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05731791 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration given its seal of approval to ARM 1-CT based breast radiation treatment?

"Our team at Power assigns the safety of ARM 1 - CT-based breast radiation treatment a score of 3, as this is an advanced Phase 3 trial. Thus far, it has demonstrated promising efficacy and been thoroughly evaluated for potential harm to participants."

Answered by AI

Are participants of legal age being enrolled in this investigation?

"This medical trial has set eligibility criteria at a minimum of 50 years old and maximum of 90. Notably, there are 51 clinical trials available to applicants below the age of 18, while 1334 studies accept senior citizens above 65."

Answered by AI

Is this study currently enrolling participants?

"The clinicaltrials.gov website indicates that enrollment for this trial has been suspended, as the last update was on February 7th 2021. However, there are 1,401 other studies actively recruiting individuals at present."

Answered by AI

Who fulfills the eligibility criteria of this research study?

"This clinical study is looking to recruit 380 individuals with a breast cancer diagnosis, ranging from 50 up to 90 years in age. Necessary criteria include: histologically confirmed unilateral DCIS or Stage I invasive breast cancer; post segmental mastectomy if unilateral, pT1 tumor ≤ 2 cm and excision margin ≥ 1 mm; negative margins for both sides of the body; clinically N0/pN0 status or sentinel node negative; no presence of ductal carcinoma on inked margins."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial to Compare MRI-guided Precision Prone Irradiation (PPI) Versus CT-guided Breast Irradiation

2023. "Trial to Compare MRI-guided Precision Prone Irradiation (PPI) Versus CT-guided Breast Irradiation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05731791.