PET/MR in Surgical Planning for Breast CA Treated With Neoadj Chemo

NCT ID: NCT04149353

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-05
• Study Completion Date: 2020-02-17

Brief Summary

Purpose: To assess the utility of combined, simultaneous positron emission tomography (PET) and magnetic resonance imaging (MRI), collectively called PET-MR, in assessing response to neoadjuvant chemotherapy and surgical treatment decisions for operable breast cancers.

Participants: Adult patients with operable breast cancer that are being treated at UNC with neoadjuvant chemotherapy followed by potentially curative surgical resection.

Procedures (methods): Patients who are being treated with neoadjuvant chemotherapy followed by surgical resection and for whom pre- and post-treatment MR imaging is part of planned treatment will undergo additional pre-treatment and post-treatment PET/MR. The response to treatment will be assessed at post-treatment by evaluating change in tumor size from MRI, change in response to dynamic contrast enhanced (DCE) MRI, and 18F-fluorodeoxyglucose (18F-FDG) avidity from PET. Patients will then undergo surgery. Their pathology will be reviewed for treatment effect as assessed by residual cancer burden (RCB) score. Patients will be followed and assessed for recurrence.

Detailed Description

Investigators propose that the changes indicated by PET/MR imaging from pre-treatment to post-treatment time points will accurately predict the patient's response to neoadjuvant chemotherapy, providing useful prognostic and surgical-planning information. The study will enroll patients with operable breast cancer being treated with neoadjuvant chemotherapy followed by potentially curative surgical resection. The standard of care for these patients would not normally include PET imaging but may include MR imaging. Patients in the study will receive combined PET/MR imaging prior to treatment and following treatment. Then, patients will receive curative intent surgery and be followed in the usual fashion and assessed for local and/or distant recurrent disease. The pathology report will be reviewed for therapy treatment effect as assessed by Residual Cancer Burden (RCB) score. Quantitative measures from PET and MRI will be computed: the change in PET tumor-mean standardized uptake value (SUV) and tumor size as assessed by MRI, from pre- to post-treatment. The image-based quantitative measures will be correlated with the pathology outcomes to evaluate predictability of the image measures for RCB score. Patients will be followed with the intent of further correlating image measures with clinical outcomes.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PET/MR

Each patient will undergo two combined PET/MR scans. The pre-treatment and post-treatment combined PET/MR scans are for research purposes and not part of the patient's standard of care.

Group Type: EXPERIMENTAL

PET/MR

Intervention Type: DIAGNOSTIC_TEST

Patient will be scheduled for a pre-treatment PET/MR and proceed to neoadjuvant chemotherapy per the direction of the medical oncologist. Within four weeks after completion of chemotherapy the patient will undergo a post-treatment PET/MR, and proceed for curative intent surgery if they are still surgical candidates.

Interventions

PET/MR

Patient will be scheduled for a pre-treatment PET/MR and proceed to neoadjuvant chemotherapy per the direction of the medical oncologist. Within four weeks after completion of chemotherapy the patient will undergo a post-treatment PET/MR, and proceed for curative intent surgery if they are still surgical candidates.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years of age (no upper age limit)
• Signed, IRB-approved written informed consent
• Must have clinical T1-3, N0-3, M0 disease. All phenotypes are acceptable..
• Must have surgically curable disease as evaluated by the UNC Multidisciplinary Tumor Board.
• Must have pre- and post-treatment MRI imaging as part of the treatment plan.
• Must be able to meet size restrictions for the PET-MR scanner: chest depth and abdominal depth less than 27 cm (approximately the smallest 55% of women will meet this), as measured on imaging or with physical template.
• Must be in acceptable health to undergo chemotherapy and curative intent surgery as assessed by Multidisciplinary Tumor Board.
• Must be able to understand and comply with study procedures for the entire length of the study.
• Must receive their chemotherapy and curative intent surgery at UNC Hospitals. -If patient has a history of prior malignancy, including melanoma, patient must be cancer- free for three or more years. Non-melanoma skin cancers will be included even if not cancer-free for three years.
• Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to each PET/MRI

Exclusion Criteria

• Inability to tolerate MRI (e.g., inability to lie flat for >1 hour)
• Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes or near pelvis that would create excessive imaging artifact
• Poorly controlled diabetes mellitus
• Patient receiving neoadjuvant endocrine therapy (due to low likelihood of complete response)
• Pregnancy or lactating female
• Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study
• Evidence of distant disease on physical exam or initial imaging
• Medical conditions precluding chemotherapy or curative intent surgery
• Incarcerated or otherwise institutionalized at time of enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Lalush, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Biomedical Engineering

Locations

UNC- Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://unclineberger.org

UNC Lineberger Comprehensive Cancer Center

Other Identifiers

LCCC 1716

Identifier Type: -

Identifier Source: org_study_id