Breast Cancer FemaleNCT03163316
The Role of Magnetic Resonance Imaging in Assessment of Axillary Lymph Nodes Metastasis in Breast Cancer Patients.
An observational study of Breast Cancer Female, run by Assiut University at 2 sites in Egypt.
Trial summary
Breast cancer is the most common cancer among women worldwide.The main cause of cancer related death is the invasion and metastasis. The usual site of spread outside the breast is to lymph nodes in the axilla. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Unenhanced magnetic resonance imaging.
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Dec 2017to 1 Jul 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female patients who are coming to South Egypt Cancer Institute- Assiut University and proved positive for primary breast cancer by histopathology with axillary lymph nodes detected clinically or with superficial ultrasound on both axillae.
Who may be able to join
- 1) Patients who proved positive for primary breast cancer by histopathology with axillary lymph nodes detected clinically or with superficial ultrasound on both axillae.
- 2) The included lymph nodes with minimal axial diameter (4mm).
Who cannot join
- 1)Patients who have a heart pacemaker as they are absolutely contraindicated for magnetic resonance imaging.
- 2) Patients with severe claustrophobia. 3) Patients undergoing any type of neoadjuvant chemo-, immune- or endocrine therapy.
- 4) Patients with history of axillary surgery or treatment. 5) Patients with recurrent axillary disease.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: The Role of Unenhanced Magnetic Resonance Imaging in Quantitative Assessment of Metastatic Involvement of Axillary Lymph Nodes in Patients With Breast Cancer: Observational Descriptive Study.
Breast cancer is the most common cancer among women worldwide.The main cause of cancer related death is the invasion and metastasis. The usual site of spread outside the breast is to lymph nodes in the axilla.
Read the detailed description
The presence of axillary metastasis is important for prognosis and determining of treatment plan, so identification of axillary metastasis in early stage newly diagnosed breast cancer is important for staging of disease and treatment. However, approximately 40% of women who presents with early stage breast cancer also have axillary metastasis.
The status of lymph nodes in patients with breast cancer used to be evaluated with axillary lymph node dissection. During the last 15 years, sentinel lymph node biopsy has replaced for grading of patients with clinically lymph node negative breast cancer. Despite being a less invasive method when compared to axillary lymph node dissection, sentinel lymph node biopsy also leads to complications such as lymphedema, seroma, localized swelling, pain, paresthesia, decrease in arm strength, infectious neuropathy and shoulder stiffness in 20% of patients.
The imaging modalities for assessing the axillary lymph nodes are rapidly evolving. Ultrasound is applied widely for its convincing and dynamic observation. However, the sensitivity and specificity of ultrasound for lymph node metastasis were unreliable and controversial.
Owing to radiation and relative lower diagnostic accuracy, computed tomography is limited in clinic.
Positron emission tomography and positron emission tomography/computed tomography can reflect metabolism of glycolytic activity. Undoubtedly, they have shown the higher diagnostic significance in assessing distant metastasis and regional metastatic axillary lymph nodes, but their high radiation and expensive fee keep the common people away. Ultrasmall super paramagnetic iron oxide is the same.
Magnetic resonance imaging is developing with an unimaginable speed. Over the past years, it has been used to evaluate axillary lymph nodes. Its sensitivity and specificity for metastatic axillary lymph nodes were higher than ultrasound and computed tomography.
Diffusion weighted imaging is an advanced magnetic resonance imaging application which derives its image contrast from the differences in water mobility in the extracellular spaces, reflecting cellular density, organization, microstructure and microcirculation.
Several studies have shown that diffusion weighted imaging can serve as a powerful tool for differentiating benign from malignant breast lesions. In addition to this use, diffusion weighted imaging may also be used in the assessment of axillary lymph nodes, since they show similar tissue characteristics to the primary tumor.
Evaluation of lymph nodes is a promising novel application of diffusion weighted imaging , which can easily be applied as an adjunct to conventional breast magnetic resonance imaging . There are a few preliminary studies that have shown that diffusion weighted imaging can be used to detect lymph nodes affected by malignant cells. Koh reported that after the involvement of nodes with malignancy, they undergo changes and the increase in cellularity leads to diffusion restriction and low apparent diffusion coefficient values.
- Conditions
- Breast Cancer Female
- Being tested
- Unenhanced magnetic resonance imaging.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unenhanced magnetic resonance imaging.Other
The axillary lymph nodes will be evaluated on axial Time 1-weighted images obtained without fat saturation. We will measure the largest dimension and cortical thickness of each lymph node and ratio of the two measurements will be calculated.
The lymph nodes seen in Time 1-weighted images will be subsequently identified on the diffusion-weighted images to calculate the apparent diffusion coefficient value of each lymph node.
Axillary lymph nodes scanned by magnetic resonance imaging will be compared by results of histopathological examination.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients | Patients will undergo unenhanced magnetic resonance imaging on both axillae. Receives: Other: Unenhanced magnetic resonance imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of unenhanced magnetic resonance imaging in assessment of axillary lymph node metastasis in breast cancer patients.
number of malignant axillary lymph nodes are accurately diagnosed by unenhanced magnetic resonance imaging in compared with histopathological result.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 Dec 2017
- Primary completion1 Jun 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandy Harby, Assiut University
- Investigators
- Sandy HN Ghaly, MBBCh, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163316
- Sponsor's protocol ID
- MRIALBC
- Status last verified
- Dec 2017
- First submitted
- 20 May 2017
- Last updated
- 3 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harnan SE, Cooper KL, Meng Y, Ward SE, Fitzgerald P, Papaioannou D, Ingram C, Lorenz E, Wilkinson ID, Wyld L. Magnetic resonance for assessment of axillary lymph node status in early breast cancer: a systematic review and meta-analysis. Eur J Surg Oncol. 2011 Nov;37(11):928-36. doi: 10.1016/j.ejso.2011.07.007. Epub 2011 Aug 19.
PubMed 21855267Heusner TA, Kuemmel S, Hahn S, Koeninger A, Otterbach F, Hamami ME, Kimmig KR, Forsting M, Bockisch A, Antoch G, Stahl A. Diagnostic value of full-dose FDG PET/CT for axillary lymph node staging in breast cancer patients. Eur J Nucl Med Mol Imaging. 2009 Oct;36(10):1543-50. doi: 10.1007/s00259-009-1145-6. Epub 2009 May 5.
PubMed 19415270Harada T, Tanigawa N, Matsuki M, Nohara T, Narabayashi I. Evaluation of lymph node metastases of breast cancer using ultrasmall superparamagnetic iron oxide-enhanced magnetic resonance imaging. Eur J Radiol. 2007 Sep;63(3):401-7. doi: 10.1016/j.ejrad.2007.02.010. Epub 2007 Mar 29.
PubMed 17398053Bedi DG, Krishnamurthy R, Krishnamurthy S, Edeiken BS, Le-Petross H, Fornage BD, Bassett RL Jr, Hunt KK. Cortical morphologic features of axillary lymph nodes as a predictor of metastasis in breast cancer: in vitro sonographic study. AJR Am J Roentgenol. 2008 Sep;191(3):646-52. doi: 10.2214/AJR.07.2460.
PubMed 18716089Koh DM, Collins DJ. Diffusion-weighted MRI in the body: applications and challenges in oncology. AJR Am J Roentgenol. 2007 Jun;188(6):1622-35. doi: 10.2214/AJR.06.1403.
PubMed 17515386
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Unenhanced Magnetic Resonance Imaging in Quantitative Assessment of Metastatic Involvement of Axillary Lymph Nodes in Patients With Breast Cancer: Observational Descriptive Study.
- ClinicalTrials.gov ID
- NCT03163316
- Acronym / sponsor ID
- MRIALBC
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 23 May 2017 (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.
Breast cancer is the most common cancer among women worldwide.The main cause of cancer related death is the invasion and metastasis. The usual site of spread outside the breast is to lymph nodes in the axilla.
Detailed description
The presence of axillary metastasis is important for prognosis and determining of treatment plan, so identification of axillary metastasis in early stage newly diagnosed breast cancer is important for staging of disease and treatment. However, approximately 40% of women who presents with early stage breast cancer also have axillary metastasis.
The status of lymph nodes in patients with breast cancer used to be evaluated with axillary lymph node dissection. During the last 15 years, sentinel lymph node biopsy has replaced for grading of patients with clinically lymph node negative breast cancer. Despite being a less invasive method when compared to axillary lymph node dissection, sentinel lymph node biopsy also leads to complications such as lymphedema, seroma, localized swelling, pain, paresthesia, decrease in arm strength, infectious neuropathy and shoulder stiffness in 20% of patients.
The imaging modalities for assessing the axillary lymph nodes are rapidly evolving. Ultrasound is applied widely for its convincing and dynamic observation. However, the sensitivity and specificity of ultrasound for lymph node metastasis were unreliable and controversial.
Owing to radiation and relative lower diagnostic accuracy, computed tomography is limited in clinic.
Positron emission tomography and positron emission tomography/computed tomography can reflect metabolism of glycolytic activity. Undoubtedly, they have shown the higher diagnostic significance in assessing distant metastasis and regional metastatic axillary lymph nodes, but their high radiation and expensive fee keep the common people away. Ultrasmall super paramagnetic iron oxide is the same.
Magnetic resonance imaging is developing with an unimaginable speed. Over the past years, it has been used to evaluate axillary lymph nodes. Its sensitivity and specificity for metastatic axillary lymph nodes were higher than ultrasound and computed tomography.
Diffusion weighted imaging is an advanced magnetic resonance imaging application which derives its image contrast from the differences in water mobility in the extracellular spaces, reflecting cellular density, organization, microstructure and microcirculation.
Several studies have shown that diffusion weighted imaging can serve as a powerful tool for differentiating benign from malignant breast lesions. In addition to this use, diffusion weighted imaging may also be used in the assessment of axillary lymph nodes, since they show similar tissue characteristics to the primary tumor.
Evaluation of lymph nodes is a promising novel application of diffusion weighted imaging , which can easily be applied as an adjunct to conventional breast magnetic resonance imaging . There are a few preliminary studies that have shown that diffusion weighted imaging can be used to detect lymph nodes affected by malignant cells. Koh reported that after the involvement of nodes with malignancy, they undergo changes and the increase in cellularity leads to diffusion restriction and low apparent diffusion coefficient values.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients | – | Other: Unenhanced magnetic resonance imaging.Patients will undergo unenhanced magnetic resonance imaging on both axillae. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female patients who are coming to South Egypt Cancer Institute- Assiut University and proved positive for primary breast cancer by histopathology with axillary lymph nodes detected clinically or with superficial ultrasound on both axillae.
Key inclusion criteria (2 listed)
- 1) Patients who proved positive for primary breast cancer by histopathology with axillary lymph nodes detected clinically or with superficial ultrasound on both axillae.
- 2) The included lymph nodes with minimal axial diameter (4mm).
Key exclusion criteria (3 listed)
- 1)Patients who have a heart pacemaker as they are absolutely contraindicated for magnetic resonance imaging.
- 2) Patients with severe claustrophobia. 3) Patients undergoing any type of neoadjuvant chemo-, immune- or endocrine therapy.
- 4) Patients with history of axillary surgery or treatment. 5) Patients with recurrent axillary disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unenhanced magnetic resonance imaging.The axillary lymph nodes will be evaluated on axial Time 1-weighted images obtained without fat saturation. We will measure the largest dimension and cortical thickness of each lymph node and ratio of the two measurements will be calculated. The lymph nodes seen in Time 1-weighted images will be subsequently identified on the diffusion-weighted images to calculate the apparent diffusion coefficient value of each lymph node. Axillary lymph nodes scanned by magnetic resonance imaging will be compared by results of histopathological examination. | Other | Breast cancer patients |
Primary outcome
Accuracy of unenhanced magnetic resonance imaging in assessment of axillary lymph node metastasis in breast cancer patients.
Time frame: one month
number of malignant axillary lymph nodes are accurately diagnosed by unenhanced magnetic resonance imaging in compared with histopathological result.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 21855267Harnan SE, Cooper KL, Meng Y, Ward SE, Fitzgerald P, Papaioannou D, Ingram C, Lorenz E, Wilkinson ID, Wyld L. Magnetic resonance for assessment of axillary lymph node status in early breast cancer: a systematic review and meta-analysis. Eur J Surg Oncol. 2011 Nov;37(11):928-36. doi: 10.1016/j.ejso.2011.07.007. Epub 2011 Aug 19.
- Background: PubMed 19415270Heusner TA, Kuemmel S, Hahn S, Koeninger A, Otterbach F, Hamami ME, Kimmig KR, Forsting M, Bockisch A, Antoch G, Stahl A. Diagnostic value of full-dose FDG PET/CT for axillary lymph node staging in breast cancer patients. Eur J Nucl Med Mol Imaging. 2009 Oct;36(10):1543-50. doi: 10.1007/s00259-009-1145-6. Epub 2009 May 5.
- Background: PubMed 17398053Harada T, Tanigawa N, Matsuki M, Nohara T, Narabayashi I. Evaluation of lymph node metastases of breast cancer using ultrasmall superparamagnetic iron oxide-enhanced magnetic resonance imaging. Eur J Radiol. 2007 Sep;63(3):401-7. doi: 10.1016/j.ejrad.2007.02.010. Epub 2007 Mar 29.
- Background: PubMed 18716089Bedi DG, Krishnamurthy R, Krishnamurthy S, Edeiken BS, Le-Petross H, Fornage BD, Bassett RL Jr, Hunt KK. Cortical morphologic features of axillary lymph nodes as a predictor of metastasis in breast cancer: in vitro sonographic study. AJR Am J Roentgenol. 2008 Sep;191(3):646-52. doi: 10.2214/AJR.07.2460.
- Background: PubMed 17515386Koh DM, Collins DJ. Diffusion-weighted MRI in the body: applications and challenges in oncology. AJR Am J Roentgenol. 2007 Jun;188(6):1622-35. doi: 10.2214/AJR.06.1403.
- Individual participant dataSharing planned: No
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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.
Sandy HN Ghaly, MBBCh principal investigator
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by Assiut University at 2 sites 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of unenhanced magnetic resonance imaging in assessment of axillary lymph node metastasis in breast cancer patients. (time frame: one month). 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 NCT03163316, which also lists 5 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 3 Aug 2021.