Imaging the Patterns of Breast Cancer Early Metastases

NCT ID: NCT02706964

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2022-02-16

Brief Summary

Currently, once a distant breast metastasis has been diagnosed, 65% of patients will succumb to their cancer within 2 years, and 80% will succumb by 5 years. The current National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Breast Cancer do not recommend surveillance imaging for earlier detection of distant metastases, even for high-risk breast cancer patients. Whereas, the standard-of-care treatment of the small isolated (few in number) breast cancer metastases is to perform surgical resection or locally ablative radiation therapy, however, the follow-up of breast cancer patients (including those with a >= 30% risk of developing metastases) is to wait for clinical symptoms to appear before using a dual positron emission tomography (PET) and diagnostic quality computed tomography (CT) PET/CT scan, magnetic resonance imaging (MRI), computed tomography (CT) or a bone scan to identify the site and extent of spread. Unfortunately, once metastases become symptomatic they are often too large and/or numerous to treat with curative intent. The current national care guidelines that advocate against intensive surveillance for distant metastases are based on two studies performed in Italy from 1985-1993 that concluded that the available imaging and treatment tools of the day did not prolong 5-year survival. Since then, however, there have been major improvements in imaging and treatment technology. To be treatable the metastases must be limited in number and limited in size, typically 6 or fewer metastases, each of size 5 centimeter or less. This state of metastatic presentation is called oligometastases. Numerous pilot studies have achieved dramatically improved overall and disease-free survival when oligometastases are treated using a combined systemic plus locally-ablative therapy of each oligometastasis. A scientific concern with the aforementioned research studies involving ablation of isolated oligometastases, was that they were not carried out with consistent use of surveillance imaging. Instead, these studies effectively preselected patients for enrollment based upon having an existing oligometastatic presentation. The primary objectives of the research study are to: (1) determine the feasibility of the stated interventions in a multi-institutional setting; (2) document the patterns of early metastatic spread of breast cancer; (3) document the proportion of high-risk breast cancer patients that have an oligometastatic presentation within this proactive imaging protocol, and (4) provide a basis to determine how to optimize future surveillance imaging protocols with respect to the time to progression, rate of tumor growth and organs that are affected.

Detailed Description

All enrolled subjects will undergo a single whole-body dual positron emission tomography (PET) and diagnostic quality computed tomography (CT) PET/CT scan and a CT scan with contrast acquired in the same imaging session; and a single brain magnetic resonance imaging (MRI) scan with contrast to be completed in separate imaging session but within 2 weeks of the PET/CT scan. Imaging will take place within 7 months after enrollment. In addition, the medical records related to the breast cancer and care, obtained and maintained as per standard-of-care, will be monitored for up to 5 years.

In this research study the investigators will acquire a PET/CT image of the body (neck to mid-thigh) using best-practice diagnostic imaging protocols, typically involving 64-slice CT systems, 1x1x3 mm voxel dimensions, use of non-ionic contrast agents, and breath-holding for motion correction. Subjects will also receive a single MRI with injected contrast of the brain using best-practice diagnostic imaging protocols, typically involving a 3-Tesla clinical MRI system.

Conditions

Breast Cancer

Study Design

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

Study Groups

Proactive imaging

All enrolled subjects will under go a single whole-body Positron emission tomography/x-ray computed tomography (PET/CT) scan and a diagnostic-quality x-ray computed tomography (CT) scan with contrast acquired in the same imaging session; and a single brain magnetic resonance imaging (MRI) scan with contrast to be completed in separate imaging session but within 2 weeks of the PET/CT scan. Imaging will take place within 7 months after enrollment.

Group Type: EXPERIMENTAL

Positron emission tomography/x-ray computed tomography

Intervention Type: DEVICE

A whole-body PET/CT will be performed to identify the site and extent of spread.

Magnetic resonance imaging

Intervention Type: DEVICE

A brain MRI will be performed.

x-ray computed tomography (CT)

Intervention Type: DEVICE

A CT scan will be performed to identify the site and extent of spread.

Interventions

Positron emission tomography/x-ray computed tomography

A whole-body PET/CT will be performed to identify the site and extent of spread.

Intervention Type: DEVICE

Magnetic resonance imaging

A brain MRI will be performed.

Intervention Type: DEVICE

x-ray computed tomography (CT)

A CT scan will be performed to identify the site and extent of spread.

Intervention Type: DEVICE

Other Intervention Names

PET/CT; MRI; CT

Eligibility Criteria

Inclusion Criteria

• Female patients with breast cancer who have completed radiation therapy within the last 48 months with a diagnosis that associates them with high risk (>30%) for developing metastatic disease but who at the time of enrollment are not known to have metastatic disease. Patients meeting this criterion are those that have either of the following presentations:
• hormone receptor (or triple) negative breast cancer with 3 or more positive axillary lymph nodes;
• a Stage III diagnosis;
• a primary tumor >2 cm and positive axillary lymph nodes;
• multiple primary tumors with cumulative volume >= that of a single 2 centimeter tumor, and positive axillary lymph nodes
• any number of lymph nodes with extranodal extension;
• any internal mammary or supraclavicular nodes;
• any primary tumor that has grown into the chest wall or skin;
• or inflammatory breast cancer.

Exclusion Criteria

• Patients not willing to submit to a PET/CT scan and a brain MRI scan with injected vascular contrast at the Department of Radiology at University of Florida or University of Miami.
• Pregnant women are excluded because of possible radiation risk to the fetus.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Florida Academic Cancer Center Alliance

UNKNOWN

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter G O'Dell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida, Assistant Professor of Radiation Oncology

Locations

Department of Radiation Oncology Davis Cancer Pavilion

Gainesville, Florida, United States

University of Miami, Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Countries

United States

Other Identifiers

IRB201500683

Identifier Type: -

Identifier Source: org_study_id