Ultrasonography Screening for Breast Lesions During Pregnancy and Lactation

NCT05568628 | Unknown

• 1 other identifier: Soh-Med-22-09-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preganat and Lactating Faemls

Outcome Measures

Primary Outcomes (1)

• percent of breast lesions in pregnant and lactating females'

  percent of breast lesions in pregnant and lactating females'

  12 month

Study Arms (2)

lacating femals

screening of breast lesions in lactating female

Device: ultrasound

pregnant

screening of breast lesions in pregnant female

Device: ultrasound

Interventions

ultrasound DEVICE

screening of breast lesions by ultrasonography

lacating femals; pregnant

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

• 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.

  PMID: 26341843 BACKGROUND

• 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.

  PMID: 24485752 BACKGROUND

• 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.

  PMID: 26456897 BACKGROUND

• 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.

  PMID: 28189388 BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

heba G ahmed, resident doctor

CONTACT

01067986223; hebatallah_07649@med.sohag.edu.eg

Mohamed Z ali, professor

CONTACT

01001119166

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at sohag cancer institute

Study Record Dates

• First Submitted: October 2, 2022
• First Posted: October 5, 2022
• Study Start: November 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

EG (1)