Quantitative MRI Assessment of Breast Cancer Therapy Response

Launched by WILLIAM BEAUMONT HOSPITALS · Jan 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how different MRI techniques can help doctors better understand how breast cancer responds to treatment before surgery. The goal is to see if looking at changes in the tumor's blood vessels and the number of cancer cells inside can provide more accurate information about how well the treatment is working, compared to just measuring the size of the tumor. This research is happening at three universities using various types of MRI machines, and it aims to improve how doctors plan surgical treatment for patients.

To participate in this study, patients need to have confirmed breast cancer and be scheduled to receive standard chemotherapy before surgery. They should not have any conditions that would prevent them from having an MRI, such as a pacemaker, and must be healthy enough to receive a special contrast dye used during the scan. Participants can expect to undergo MRI scans that will last about 45 minutes, and they will need to provide informed consent before joining the study. This trial is observational, meaning the MRI procedures are not expected to change patients' health outcomes, but they will help researchers learn more about the best ways to evaluate treatment response.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with histologically confirmed breast cancer who are scheduled to receive standard of care neoadjuvant chemotherapy prior to surgical management
• • No contraindication for an MRI exam
• • Normal kidney functional for receiving a standard dose of gadolinium-based MRI contrast agent through IV injection
• • Not pregnant
• • Ability to understand and the willingness to sign a written informed consent document. A signed study-specific informed consent must be obtained prior to any study specific procedures
• Exclusion Criteria:
• • Patients who would be normally excluded from undergoing an MRI examination - patients with a pacemaker, aneurysm clip, or any other condition that would warrant avoidance of a strong magnetic field
• • Patients who are unable to cooperate for an MRI exam lasting about 45 min, and/or have known allergic reaction to gadolinium-based contrast agent
• • Severe claustrophobia precluding subject from undergoing MRI
• • Patients with acute or chronic kidney dysfunction (estimated glomerular filtration rate \[eGFR\] \< 60 ml/min/1.73 m\^2 as calculated using the Modification of Diet in Renal Disease \[MDRD\] equation)
• • Pregnant participants are excluded from this study because it is difficult for them to lie prone on the MRI table and because of possible risk to the fetus
• • Cognitively impaired