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

Utility of PET/MR in Surgical Planning for Breast Cancer Treated With Neoadjuvant Chemotherapy

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: PET/MR

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC- Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PET Activity Estimates From Pre-treatment to Post-treatment	Primary endpoint is the determination of the potential for PET activity estimates to predict RCB score in comparison with that of dynamic contrast enhanced (DCE) MRI. Treatment response will be determined on final pathological evaluation of the resected specimens by way of the RCB score.	Time Frame: Changes in image measures will be assessed from baseline scans, prior to therapy, to post-treatment scans, taken six months after baseline. Pathology data will be obtained post-surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of Metrics Combining Multiple Features From PET and MR in Prediction of Response to Therapy	Quantitative image measures from PET and MR will be compiled and an optimal linear regression will be derived between the image metrics and the outcome measure from pathology, the RCB score. Prediction performance of the regression relation will be assessed using a leave-one-out cross-validation approach.	Changes in image measures will be assessed from baseline scans, prior to therapy, to post-treatment scans, taken six months after baseline. Pathology data will be obtained post-surgery.

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: David Lalush, PhD, UNC Biomedical Engineering

Publications and helpful links

Helpful Links

• UNC Lineberger Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Actual): February 20, 2019
• Study Completion (Actual): February 17, 2020

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 12, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: LCCC 1716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes