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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03190083
Other study ID # CASE6117
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2017
Est. completion date June 13, 2018

Study information

Verified date June 2022
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if a 3-dimensional mammogram (DBT) may provide additional information to evaluate the extent of disease and additional findings that would aid in staging a new breast cancer patient. This would impact surgical planning and improve patient outcomes.


Description:

Primary Objective: The primary objective of the study is to measure the frequency with which DBT alters the surgical plan to mastectomy versus lumpectomy. Only positive findings, like an additional site of cancer or DCIS, will be taken into account when estimating the frequency of changes to surgical management. Secondary objectives: 1. To measure the frequency and nature of additional findings like atypical pathology (Atypical ductal/ lobular hyperplasia, papilloma, Lobular carcinoma in situ (LCIS) , requiring surgical intervention). 2. To identify variables on 2D (e.g. dense breasts, architectural distortions, non calcified masses) that might predict which patients would benefit from DBT. 3. To measure the proportion of patients undergoing additional work-up following the DBT, and the subset of these patients with benign findings (i.e. False Positives).


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date June 13, 2018
Est. primary completion date June 13, 2018
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 85 Years
Eligibility Inclusion Criteria: - New diagnosis of breast cancer - New diagnosis if a previous breast cancer patient with negative surgical margins - Patients willing to sign a written informed consent form Exclusion Criteria: - High risk benign lesions as the primary pathology diagnosis

Study Design


Related Conditions & MeSH terms


Intervention

Device:
2-dimensional mammogram
This is standard of care for breast cancer diagnosis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.
digital breast tomosynthesis (DBT)
The radiation dose from this/these procedure(s) will be no more than 0.4mSv for a bi-lateral breast tomosynthesis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.

Locations

Country Name City State
United States Cleveland Clinic, Case Comprehensive Cancer Center Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Variables on 2-Dimensional Mammogram That Might Predict Which Patients Would Benefit From DBT At completion of 3-Dimensional mammogram (1 day)
Other The Proportion of Patients Undergoing Additional Work-up Following the DBT At completion of 3-Dimensional mammogram (1 day)
Other Number of Patients Undergoing Additional Work-up Following the DBT With Benign Findings At completion of 3-Dimensional mammogram (1 day)
Primary Number of Participants for Which DBT Altered Surgical Plan Only positive findings, like an additional site of cancer or atypical pathology like Atypical ductal/ lobular hyperplasia, papilloma, DCIS/LCIS (findings requiring surgical intervention), will be taken into account when estimating the frequency of changes to surgical management At completion of 3-Dimensional mammogram (1 day)
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