Imaging the Patterns of Breast Cancer Early Metastases

NCT02706964 | Completed

• 1 other identifier: IRB201500683
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

metastasis; 3D imaging; early detection

Outcome Measures

Primary Outcomes (6)

• Proportion of patients with oligometastatic presentation

  Count the number of metastatic lesions at first imaging-incidence of presentation based on radiologist findings and application of the PI's computer-based automatic tumor detection program. If the number is 5 or less and none are \> 5 cm in diameter, then this defines and oligometastatic presentation. Comparator: when metastases are first detected upon presentation of clinical symptoms, only 18% of patients are oligometastatic.

  year 1

• Histogram of the number and size of metastases at first presentation.

  Count of the number of metastases and their size based on radiologists findings and application of the PI's computer-based automatic tumor detection and sizing program. Goal to generate a histogram of tumor number and size.

  year 1

• Measure time to first instance of metastatic presentation.

  Record when the metastases are first discovered across the population of patient subjects.

  year 1

• Measure the growth rates of metastases in each of the target organs.

  Based on repeated follow-up scans we will use the PI's automated tumor sizing algorithm to computer tumor growth rates and compare growth rates across the different organs to which breast cancer spreads to (e.g., lung, liver, brain, spine).

  year 1

• Measure the incidence of metastatic spread to each target organ.

  Count of the number of metastases to each distant site, and their incidence, based on radiologists findings.

  year 1

• Prognosis for oligometastases based on patient and tumor factors.

  Measure primary breast tumor factors of size, number, type (ER/PR/HER2, luminal, basal), stage, nodal stage, etc., and patient factors of age, race, smoking history, etc. and correlate this in a multivariate analysis with the number of metastases at first presentation (including proportion of patients with oligometastases).

  year 1

Secondary Outcomes (3)

• Local control outcomes of treatment of metastases

  Years 1-5

• Acute and late clinical side effects for ablative local therapy of the metastases

  Years 1-5

• Patterns of secondary recurrence

  Years 1-5

Study Arms (1)

Proactive imaging

EXPERIMENTAL

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.

Device: Positron emission tomography/x-ray computed tomography; Device: Magnetic resonance imaging; Device: x-ray computed tomography (CT)

Interventions

Positron emission tomography/x-ray computed tomography DEVICE

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

Also known as: PET/CT

Proactive imaging

Magnetic resonance imaging DEVICE

A brain MRI will be performed.

Also known as: MRI

Proactive imaging

x-ray computed tomography (CT) DEVICE

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

Also known as: CT

Proactive imaging

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• Florida Academic Cancer Center Alliance: collaborator

Study Sites (2)

Department of Radiation Oncology Davis Cancer Pavilion

Gainesville, Florida, 32611, United States

Location

University of Miami, Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Positron Emission Tomography Computed Tomography; Magnetic Resonance Imaging; Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Walter G O'Dell, PhD

  University of Florida, Assistant Professor of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 11, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: February 16, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)