Evaluation of Different Imaging Modalities in Regional Lymph Nodes Staging in Patients With Breast Cancer

NCT06185946 | Unknown

• 1 other identifier: Soh_med_23_11_02MD
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The regional lymph node status is considered to be an important prognostic factor regarding the long-term survival of breast cancer (BC) patients (Cetin IA, et al . 2020). The knowledge of whether lymph nodes are tumor-infiltrated or not is essential since nodal involvement has decisive therapeutic consequences such as axillary lymph node dissection (ALND), axillary radiotherapy, and neoadjuvant or adjuvant systemic chemotherapy (Diessner J et al . 2023). To provide individualized therapeutic options and optimized therapy.

Conditions

Breast Carcinoma Metastatic in Lymph Node

Outcome Measures

Primary Outcomes (1)

• evaluate the sensitivity of different Imaging modality pretherapeutic imaging modalities (sonography, mammography, CT and MRI) in pretherapeutic assessment of nodal-status in BC patients .

  one year

Secondary Outcomes (1)

• to find out if there is further benefit of using cross-sectional imaging (MRI, CT) for pretherapeutic axillary staging compared to Us and mammogram conventional imaging such as mammography and sonogram.

  one year

Study Arms (4)

ultrasonography group

mammoragraphy group

patient with ultrasoundy only

CT group

pateint with postive node undergo further staging

MRI group

patient whit postive node with staging

Eligibility Criteria

• Age: 25 Years - 65 Years
• Gender Eligibility Details: female over 25 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The plan is to study a population of 100 patients of BC presenting to Sohag university And NCI in breast cancer clinic surgery the Late 2023 and 2024

You may qualify if:

• Patient consenting to participate in the study.
• Patients who can tolerate the imaging modalities and have proven to tolerate the contrast agents . 3) Breast cancer patients coming for an initial assessment with or without clinical regional lymph nodes positive status.
• \) Breast cancer patients planned to have(breast-conserving surgery or mastectomy)as well as lymph node surgeries(sentinel lymph node v biopsy and/or axillary lymph node dissection.

You may not qualify if:

• )Patients denying consent to participate in the study 2) Patients who are not fit for further imaging evaluation (patients who exceed the weight limit, patients who are sensitive to contrast material, etc). 3) Patients with bilateral MRM and AC

Sponsors & Collaborators

• Mennatallah Arous Mohamed: lead

Study Sites (1)

National Cancer Institute

Cairo, 007, Egypt

RECRUITING

Related Publications (18)

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  PMID: 31878958 BACKGROUND

• Bakker MF, de Lange SV, Pijnappel RM, Mann RM, Peeters PHM, Monninkhof EM, Emaus MJ, Loo CE, Bisschops RHC, Lobbes MBI, de Jong MDF, Duvivier KM, Veltman J, Karssemeijer N, de Koning HJ, van Diest PJ, Mali WPTM, van den Bosch MAAJ, Veldhuis WB, van Gils CH; DENSE Trial Study Group. Supplemental MRI Screening for Women with Extremely Dense Breast Tissue. N Engl J Med. 2019 Nov 28;381(22):2091-2102. doi: 10.1056/NEJMoa1903986.

  PMID: 31774954 BACKGROUND

• Caudle AS, Yang WT, Krishnamurthy S, Mittendorf EA, Black DM, Gilcrease MZ, Bedrosian I, Hobbs BP, DeSnyder SM, Hwang RF, Adrada BE, Shaitelman SF, Chavez-MacGregor M, Smith BD, Candelaria RP, Babiera GV, Dogan BE, Santiago L, Hunt KK, Kuerer HM. Improved Axillary Evaluation Following Neoadjuvant Therapy for Patients With Node-Positive Breast Cancer Using Selective Evaluation of Clipped Nodes: Implementation of Targeted Axillary Dissection. J Clin Oncol. 2016 Apr 1;34(10):1072-8. doi: 10.1200/JCO.2015.64.0094. Epub 2016 Jan 25.

  PMID: 26811528 BACKGROUND

• Cetin IA, Akay SU, Caglar Ozkok HB, Sengoz M. Lymph node ratio as an independent prognostic factor for breast cancer-related mortality in patients with node-positive breast cancer. J Cancer Res Ther. 2020 Oct-Dec;16(6):1387-1392. doi: 10.4103/jcrt.JCRT_1034_19.

  PMID: 33342802 BACKGROUND

• Choi HY, Park M, Seo M, Song E, Shin SY, Sohn YM. Preoperative Axillary Lymph Node Evaluation in Breast Cancer: Current Issues and Literature Review. Ultrasound Q. 2017 Mar;33(1):6-14. doi: 10.1097/RUQ.0000000000000277.

  PMID: 28187012 BACKGROUND

• de Meric de Bellefon M, Lemanski C, Ducteil A, Fenoglietto P, Azria D, Bourgier C. Management of the Axilla in the Era of Breast Cancer Heterogeneity. Front Oncol. 2018 Apr 4;8:84. doi: 10.3389/fonc.2018.00084. eCollection 2018.

  PMID: 29670853 BACKGROUND

• Diessner J, Anders L, Herbert S, Kiesel M, Bley T, Schlaiss T, Sauer S, Wockel A, Bartmann C. Evaluation of different imaging modalities for axillary lymph node staging in breast cancer patients to provide a personalized and optimized therapy algorithm. J Cancer Res Clin Oncol. 2023 Jul;149(7):3457-3467. doi: 10.1007/s00432-022-04221-9. Epub 2022 Aug 10.

  PMID: 35948829 BACKGROUND

• Ditsch N, Untch M, Kolberg-Liedtke C, Jackisch C, Krug D, Friedrich M, Janni W, Muller V, Albert US, Banys-Paluchowski M, Bauerfeind I, Blohmer JU, Budach W, Dall P, Diel I, Fallenberg EM, Fasching PA, Fehm T, Gerber B, Gluz O, Hanf V, Harbeck N, Heil J, Huober J, Kreipe HH, Kuhn T, Kummel S, Loibl S, Luftner D, Lux M, Maass N, Moebus V, Mundhenke C, Park-Simon TW, Reimer T, Rhiem K, Rody A, Schmidt M, Schneeweiss A, Solbach C, Solomayer EF, Stickeler E, Thomssen C, Witzel I, Wockel A, Thill M. AGO Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2020. Breast Care (Basel). 2020 Jun;15(3):294-309. doi: 10.1159/000508736. Epub 2020 Jun 10. No abstract available.

  PMID: 32774225 BACKGROUND

• Dong Y, Feng Q, Yang W, Lu Z, Deng C, Zhang L, Lian Z, Liu J, Luo X, Pei S, Mo X, Huang W, Liang C, Zhang B, Zhang S. Preoperative prediction of sentinel lymph node metastasis in breast cancer based on radiomics of T2-weighted fat-suppression and diffusion-weighted MRI. Eur Radiol. 2018 Feb;28(2):582-591. doi: 10.1007/s00330-017-5005-7. Epub 2017 Aug 21.

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• El Sabbagh YH, Hamdy O. Targeted Axillary Dissection In Breast Cancer Patients After Neoadjuvant Therapy. Mansoura Medical Journal. 2022 Dec 1;51(4):246-57.

  BACKGROUND

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• Kutomi G, Ohmura T, Satomi F, Takamaru T, Shima H, Suzuki Y, Otokozawa S, Zembutsu H, Mori M, Hirata K. Lymph node shape in computed tomography imaging as a predictor for axillary lymph node metastasis in patients with breast cancer. Exp Ther Med. 2014 Aug;8(2):681-685. doi: 10.3892/etm.2014.1787. Epub 2014 Jun 16.

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Central Study Contacts

Mennatallahh A Taha, assistant lecturer

CONTACT

00201005074579; menahallah.taha@med.sohag.edu.eg

Amira H Radwan, lecturer

CONTACT

0110000228; drtrying21@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecteurer

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 29, 2023
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 12, 2025
• Last Updated: December 29, 2023

Record last verified: 2023-12

Locations

EG (1)