Ultrasonography Screening for Breast Lesions During Pregnancy and Lactation

All breast disorders found during pregnancy and lactation should be carefully evaluated. Most of them are benign e.g., lactating adenoma, galactocele, fibroadenoma or inflammatory disorders e.g., mastitis, abscess formation, granulomatous mastitis, but it is essential to exclude pregnancy-associated breast cancer (PABC), which is too often diagnosed late Ultrasound is the first line breast imaging technique during pregnancy and lactation as Development of alveoli during pregnancy might not occur symmetrically, and these can be felt as focal nodularities, or even feel similar to masses, any suspicion of a mass should be assessed with US . If US illustrates glandular tissue and this correlates with the examiner presumption, no further work-up needs to be done. However, if presence of a mass is highly assumed, further follow-up by mammography, MRI and biopsy, when necessary, must be performed

Study Overview

• Status: Not yet recruiting
• Conditions: Preganat and Lactating Faemls
• Intervention / Treatment: Device: ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: heba G ahmed, resident doctor; Phone Number: 01067986223; Email: hebatallah_07649@med.sohag.edu.eg
• Study Contact Backup: Name: Mohamed Z ali, professor; Phone Number: 01001119166

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

- Pregnant and lactating women with or without complaining of breast pain or breast lump referred from Obstetric and Gynecological outpatient clinic or surgery outpatient clinic

Description

Inclusion Criteria:

• Pregnant and lactating women with or without complaining of breast pain or breast lump referred from Obstetric and Gynecological outpatient clinic or surgery outpatient clinic

Exclusion Criteria:

• Non pregnant, non-lactating females, females with previous breast surgery or breast mass lesions before pregnancy or lactation.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
lacating femals; screening of breast lesions in lactating female	Device: ultrasound; screening of breast lesions by ultrasonography
pregnant; screening of breast lesions in pregnant female	Device: ultrasound; screening of breast lesions by ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percent of breast lesions in pregnant and lactating females'	percent of breast lesions in pregnant and lactating females'	12 month

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Langer A, Mohallem M, Berment H, Ferreira F, Gog A, Khalifa D, Nekka I, Cherel P. Breast lumps in pregnant women. Diagn Interv Imaging. 2015 Oct;96(10):1077-87. doi: 10.1016/j.diii.2015.07.005. Epub 2015 Sep 2.
• Langer A, Mohallem M, Stevens D, Rouzier R, Lerebours F, Cherel P. A single-institution study of 117 pregnancy-associated breast cancers (PABC): Presentation, imaging, clinicopathological data and outcome. Diagn Interv Imaging. 2014 Apr;95(4):435-41. doi: 10.1016/j.diii.2013.12.021. Epub 2014 Jan 31.
• Genin AS, De Rycke Y, Stevens D, Donnadieu A, Langer A, Rouzier R, Lerebours F. Association with pregnancy increases the risk of local recurrence but does not impact overall survival in breast cancer: A case-control study of 87 cases. Breast. 2016 Dec;30:222-227. doi: 10.1016/j.breast.2015.09.006. Epub 2015 Oct 9.
• Parker S, Saettele M, Morgan M, Stein M, Winkler N. Spectrum of Pregnancy- and Lactation-related Benign Breast Findings. Curr Probl Diagn Radiol. 2017 Nov-Dec;46(6):432-440. doi: 10.1067/j.cpradiol.2016.12.013. Epub 2016 Dec 27.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): June 1, 2024

Study Registration Dates

• First Submitted: October 2, 2022
• First Submitted That Met QC Criteria: October 2, 2022
• First Posted (ACTUAL): October 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med-22-09-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No