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NCT02706964 · ClinicalTrials.gov registry record · NA
Imaging the Patterns of Breast Cancer Early Metastases
A NA study of Breast Cancer, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 13
- Enrollment target
- 2
- Study locations
NCT02706964: Completed NA study of Breast Cancer, sponsored by University of Florida.
NCT02706964 is a NA study of Breast Cancer that has completed, run by University of Florida. The registered enrollment target is 13 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02706964, a NA study of Breast Cancer, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
- 2
- Study locations
Study 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 w
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Magnetic resonance imaging
- DEVICE Positron emission tomography/x-ray computed tomography
- DEVICE x-ray computed tomography (CT)
Study Locations (2)
Florida
- Department of Radiation Oncology Davis Cancer Pavilion - Gainesville
- University of Miami, Sylvester Comprehensive Cancer Center - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2016-04 |
| Est. Completion | 2022-02-16 |
| Phase | NA |
What the finished NCT02706964 record still lists
NCT02706964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Magnetic resonance imaging is the first listed.
NCT02706964 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02706964 about?
NCT02706964 is a clinical study titled "Imaging the Patterns of Breast Cancer Early Metastases". 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 ...
What is the current status of trial NCT02706964?
This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2016-04. Estimated completion is 2022-02-16.
What conditions does trial NCT02706964 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT02706964?
The interventions under investigation include: Magnetic resonance imaging (DEVICE), Positron emission tomography/x-ray computed tomography (DEVICE), x-ray computed tomography (CT) (DEVICE).
Who is sponsoring clinical trial NCT02706964?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02706964 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02706964's enrollment target sits among peer trials
13 1161st of 1224 higher than 59 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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