NCT04863833

Brief Summary

To Estimate diagnostic value of tomo synthesis for breast mass lesions characterization ( shape, margin, and density, detail of mass margins, Differences in mass density , Tumor measurement,.)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

March 6, 2021

Last Update Submit

April 24, 2021

Conditions

Female Breast Cancer

Keywords

Tomosyntheses, X-ray--Digital Tomosynthesis-- Breast Tomosyntheses

Outcome Measures

Primary Outcomes (1)

  • diagnosis of breast mass lesions

    Mass regular in shape or not, homogeneous in echogenicity or not,calicfied or not,has speculation or not,single or multiple

    2 years

Secondary Outcomes (1)

  • characters of benign and malignant breast mass

    2 years

Eligibility Criteria

Age35 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf representative of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All female patients except mentioned in exclusion criteria . Female patients who undergoes DBT must have a compressed breast thickness of more than 2 cm; therefore, some patients will not qualify

You may qualify if:

  • female patients who undergoes DBT must have a compressed breast thickness of more than 2 cm,with small mass,age\>35,not have mastitis,not proceed breast implant

You may not qualify if:

  • Female Patients with breast implant ,severe nipple discharge, large palpable mass, mastitis and women within reproductive age(15-35 ) Female patients with huge breast that may exceed the detector size requirements for global diagnostic DBT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Asmaa Abdelmonem

CONTACT

+201123153571asmaaelshahaby@gmail.com

Eman AboElhamd, Professor

CONTACT

+201001980793dr.eman_08@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

March 6, 2021

First Posted

April 28, 2021

Study Start

September 1, 2021

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

April 28, 2021

Record last verified: 2021-04