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

NCT04149353 | Terminated Results DMC FDA Device

• 1 other identifier: LCCC 1716
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Performance of Metrics Combining Multiple Features From PET and MR in Prediction of Response to Therapy

  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.

Study Arms (1)

PET/MR

EXPERIMENTAL

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

Interventions

PET/MR 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.

PET/MR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

UNC- Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• UNC Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: David Lalush
• Organization: North Carolina State University

dslalush@ncsu.edu

919-513-7671

Study Officials

• David Lalush, PhD

  UNC Biomedical Engineering

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: November 4, 2019
• Study Start: December 5, 2018
• Primary Completion: February 20, 2019
• Study Completion: February 17, 2020
• Last Updated: June 16, 2020
• Results First Posted: March 6, 2020

Record last verified: 2020-06

Locations

US (1)