NCT03163316

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

August 3, 2021

Status Verified

December 1, 2017

Enrollment Period

3.5 years

First QC Date

May 20, 2017

Last Update Submit

July 30, 2021

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

  • 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.

    one month

Study Arms (1)

Breast cancer patients

Patients will undergo unenhanced magnetic resonance imaging on both axillae.

Other: Unenhanced magnetic resonance imaging.

Interventions

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.

Breast cancer patients

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • \- 1) Patients who proved positive for primary breast cancer by histopathology with axillary lymph nodes detected clinically or with superficial ultrasound on both axillae.
  • \) The included lymph nodes with minimal axial diameter (4mm).

You may not qualify if:

  • )Patients who have a heart pacemaker as they are absolutely contraindicated for magnetic resonance imaging.
  • \) Patients with severe claustrophobia. 3) Patients undergoing any type of neoadjuvant chemo-, immune- or endocrine therapy.
  • \) Patients with history of axillary surgery or treatment. 5) Patients with recurrent axillary disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Medicine

Asyut, Egypt

Location

South Egypt Cancer Institute

Asyut, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 21855267BACKGROUND

  • Heusner 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.

    PMID: 19415270BACKGROUND

  • Harada 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.

    PMID: 17398053BACKGROUND

  • Bedi 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.

    PMID: 18716089BACKGROUND

  • Koh 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.

    PMID: 17515386BACKGROUND

Study Officials

  • Sandy HN Ghaly, MBBCh

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2017

First Posted

May 23, 2017

Study Start

December 1, 2017

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

August 3, 2021

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)