Imaging the Patterns of Breast Cancer Early Metastases (BCMetPats)
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|ClinicalTrials.gov Identifier: NCT02706964|
Recruitment Status : Active, not recruiting
First Posted : March 11, 2016
Last Update Posted : March 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: Positron emission tomography/x-ray computed tomography Device: Magnetic resonance imaging Device: x-ray computed tomography (CT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Imaging the Patterns of Breast Cancer Early Metastases|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||March 2021|
Experimental: 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.
Device: Positron emission tomography/x-ray computed tomography
A whole-body PET/CT will be performed to identify the site and extent of spread.
Other Name: PET/CT
Device: Magnetic resonance imaging
A brain MRI will be performed.
Other Name: MRI
Device: x-ray computed tomography (CT)
A CT scan will be performed to identify the site and extent of spread.
Other Name: CT
- Proportion of patients with oligometastatic presentation [ Time Frame: year 1 ]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.
- Histogram of the number and size of metastases at first presentation. [ Time Frame: year 1 ]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.
- Measure time to first instance of metastatic presentation. [ Time Frame: year 1 ]Record when the metastases are first discovered across the population of patient subjects.
- Measure the growth rates of metastases in each of the target organs. [ Time Frame: year 1 ]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).
- Measure the incidence of metastatic spread to each target organ. [ Time Frame: year 1 ]Count of the number of metastases to each distant site, and their incidence, based on radiologists findings.
- Prognosis for oligometastases based on patient and tumor factors. [ Time Frame: year 1 ]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).
- Local control outcomes of treatment of metastases [ Time Frame: Years 1-5 ]In those patients who present with metastases under the imaging protocol and go on to receive additional treat of those metastases, to measure the local control rate and compare with historical controls.
- Acute and late clinical side effects for ablative local therapy of the metastases [ Time Frame: Years 1-5 ]In those patients who present with metastases under the imaging protocol and go on to receive additional treat of those metastases, to measure clinical acute and late side-effects of treatment and compare with historical controls.
- Patterns of secondary recurrence [ Time Frame: Years 1-5 ]Repeat each of the outcomes analyses above but for secondary instance of distant metastases instance, in those patients who receive treatment of breast cancer metastases.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02706964
|United States, Florida|
|Department of Radiation Oncology Davis Cancer Pavilion|
|Gainesville, Florida, United States, 32611|
|University of Miami, Sylvester Comprehensive Cancer Center|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Walter G O'Dell, PhD||University of Florida, Assistant Professor of Radiation Oncology|