Breast Carcinoma Metastatic in Lymph NodeNCT06185946
Evaluation of Different Imaging Modalities in Regional Lymph Nodes Staging in Patients With Breast Cancer
An observational study of Breast Carcinoma Metastatic in Lymph Node, run by Mennatallah Arous Mohamed at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Breast Carcinoma Metastatic in Lymph Node
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 12 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
- 4) 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.
Who cannot join
- 1)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
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute
Cairo, 007
Mennatallahh Taha, 01005074579, drtrying21@gmail.com
amira h radwan, 0110000228
About this study
Official title: Evaluation of Different Imaging Modalities in Regional Nodes Staging in Breast Cancer Patient
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.
Read the detailed description
The following data will be collected from electronic or paper medical data records as:
- Age 2 )Sex 3)Family history of breast cancer 4)Menopausal status 5 )Body mass index (BMI) 6) Histological type of BC as reported in pathology 7) The results of the lymph node status. 8)Registered data will be collected from the hospital databases and clinical sheers. 3 9) The gold standard reference in the evaluation of suspicious lymph nodes by nodal biopsy and postoperative pathology. Imaging technique and interpretation The imaging diagnostic for BC (MRI, CT, mammography, and ultrasound) patients are carried out by the Department of Diagnostic and Interventional Radiology of the Hospitals in the research and interpreted by radiologists at the time of BC diagnosis. The radiological reports for each patient and each imaging technique will be analyzed about the lymph node status. The nodal status will be reported as benign, indeterminate, and infiltrated as stated by the ACR lexicon. Mammography and US For mammography, we will use full-field digital mammography systems with the option of additional tomosynthesis for further characterization of the primary tumor at NCI with the commercially available The BC patients routinely receive an ultrasound exam including the evaluation of the breast and the axilla with the lymphatic drainage pathways as a part of the follow-up process active lymph nodes. p values lower than 0.05 will be considered significant.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ultrasonography group | Not described | |
| mammoragraphy group | patient with ultrasoundy only | |
| CT group | pateint with postive node undergo further staging | |
| MRI group | patient whit postive node with staging |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the sensitivity of different Imaging modality pretherapeutic imaging modalities (sonography, mammography, CT and MRI) in pretherapeutic assessment of nodal-status in BC patients .
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion12 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Breast Carcinoma Metastatic in Lymph NodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mennatallah Arous Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mennatallah Arous Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185946
- Sponsor's protocol ID
- Soh_med_23_11_02MD
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Hattali S, Vinnicombe SJ, Gowdh NM, Evans A, Armstrong S, Adamson D, Purdie CA, Macaskill EJ. Breast MRI and tumour biology predict axillary lymph node response to neoadjuvant chemotherapy for breast cancer. Cancer Imaging. 2019 Dec 26;19(1):91. doi: 10.1186/s40644-019-0279-4.
PubMed 31878958Bakker 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.
PubMed 31774954Caudle 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.
PubMed 26811528Cetin 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.
PubMed 33342802Choi 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.
PubMed 28187012de 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.
PubMed 29670853Diessner 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.
PubMed 35948829Ditsch 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.
PubMed 32774225Dong 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.
PubMed 28828635El Sabbagh YH, Hamdy O. Targeted Axillary Dissection In Breast Cancer Patients After Neoadjuvant Therapy. Mansoura Medical Journal. 2022 Dec 1;51(4):246-57.
Johnston SRD, Harbeck N, Hegg R, Toi M, Martin M, Shao ZM, Zhang QY, Martinez Rodriguez JL, Campone M, Hamilton E, Sohn J, Guarneri V, Okada M, Boyle F, Neven P, Cortes J, Huober J, Wardley A, Tolaney SM, Cicin I, Smith IC, Frenzel M, Headley D, Wei R, San Antonio B, Hulstijn M, Cox J, O'Shaughnessy J, Rastogi P; monarchE Committee Members and Investigators. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE). J Clin Oncol. 2020 Dec 1;38(34):3987-3998. doi: 10.1200/JCO.20.02514. Epub 2020 Sep 20.
PubMed 32954927Kutomi 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.
PubMed 25009640Lee SC, Jain PA, Jethwa SC, Tripathy D, Yamashita MW. Radiologist's role in breast cancer staging: providing key information for clinicians. Radiographics. 2014 Mar-Apr;34(2):330-42. doi: 10.1148/rg.342135071.
PubMed 24617682Marino MA, Avendano D, Zapata P, Riedl CC, Pinker K. Lymph Node Imaging in Patients with Primary Breast Cancer: Concurrent Diagnostic Tools. Oncologist. 2020 Feb;25(2):e231-e242. doi: 10.1634/theoncologist.2019-0427. Epub 2019 Oct 14.
PubMed 32043792Masuda N, Lee SJ, Ohtani S, Im YH, Lee ES, Yokota I, Kuroi K, Im SA, Park BW, Kim SB, Yanagita Y, Ohno S, Takao S, Aogi K, Iwata H, Jeong J, Kim A, Park KH, Sasano H, Ohashi Y, Toi M. Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy. N Engl J Med. 2017 Jun 1;376(22):2147-2159. doi: 10.1056/NEJMoa1612645.
PubMed 28564564
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Imaging Modalities in Regional Nodes Staging in Breast Cancer Patient
- ClinicalTrials.gov ID
- NCT06185946
- Acronym / sponsor ID
- Soh_med_23_11_02MD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mennatallah Arous MohamedUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 12 Jan 2025 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The following data will be collected from electronic or paper medical data records as:
- Age 2 )Sex 3)Family history of breast cancer 4)Menopausal status 5 )Body mass index (BMI) 6) Histological type of BC as reported in pathology 7) The results of the lymph node status. 8)Registered data will be collected from the hospital databases and clinical sheers. 3 9) The gold standard reference in the evaluation of suspicious lymph nodes by nodal biopsy and postoperative pathology. Imaging technique and interpretation The imaging diagnostic for BC (MRI, CT, mammography, and ultrasound) patients are carried out by the Department of Diagnostic and Interventional Radiology of the Hospitals in the research and interpreted by radiologists at the time of BC diagnosis. The radiological reports for each patient and each imaging technique will be analyzed about the lymph node status. The nodal status will be reported as benign, indeterminate, and infiltrated as stated by the ACR lexicon. Mammography and US For mammography, we will use full-field digital mammography systems with the option of additional tomosynthesis for further characterization of the primary tumor at NCI with the commercially available The BC patients routinely receive an ultrasound exam including the evaluation of the breast and the axilla with the lymphatic drainage pathways as a part of the follow-up process active lymph nodes. p values lower than 0.05 will be considered significant.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
- 4) 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.
Key exclusion criteria (2 listed)
- 1)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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluate the sensitivity of different Imaging modality pretherapeutic imaging modalities (sonography, mammography, CT and MRI) in pretherapeutic assessment of nodal-status in BC patients .
Time frame: one year
1 secondary outcome
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.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Background: PubMed 31878958Al-Hattali S, Vinnicombe SJ, Gowdh NM, Evans A, Armstrong S, Adamson D, Purdie CA, Macaskill EJ. Breast MRI and tumour biology predict axillary lymph node response to neoadjuvant chemotherapy for breast cancer. Cancer Imaging. 2019 Dec 26;19(1):91. doi: 10.1186/s40644-019-0279-4.
- Background: PubMed 31774954Bakker 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.
- Background: PubMed 26811528Caudle 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.
- Background: PubMed 33342802Cetin 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.
- Background: PubMed 28187012Choi 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.
- Background: PubMed 29670853de 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.
- Background: PubMed 35948829Diessner 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.
- Background: PubMed 32774225Ditsch 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.
- Background: PubMed 28828635Dong 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.
- BackgroundEl 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: PubMed 32954927Johnston SRD, Harbeck N, Hegg R, Toi M, Martin M, Shao ZM, Zhang QY, Martinez Rodriguez JL, Campone M, Hamilton E, Sohn J, Guarneri V, Okada M, Boyle F, Neven P, Cortes J, Huober J, Wardley A, Tolaney SM, Cicin I, Smith IC, Frenzel M, Headley D, Wei R, San Antonio B, Hulstijn M, Cox J, O'Shaughnessy J, Rastogi P; monarchE Committee Members and Investigators. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE). J Clin Oncol. 2020 Dec 1;38(34):3987-3998. doi: 10.1200/JCO.20.02514. Epub 2020 Sep 20.
- Background: PubMed 25009640Kutomi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma Metastatic in Lymph Node, run by Mennatallah Arous Mohamed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mennatallahh A Taha, assistant lecturer (00201005074579, menahallah.taha@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the sensitivity of different Imaging modality pretherapeutic imaging modalities (sonography, mammography, CT and MRI) in pretherapeutic assessment of nodal-status in BC patients . (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06185946, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.