NCT01942759

Brief Summary

The purpose of this study is to determine findings of positron emission tomography and diffusion weighted magnetic resonance in primary lesion and axillary metastasis of breast cancer and compare of two imaging modality in these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 10, 2014

Status Verified

June 1, 2014

Enrollment Period

9 months

First QC Date

September 2, 2013

Last Update Submit

June 8, 2014

Conditions

Breast Neoplasms

Keywords

Breast NeoplasmsPositron-Emission TomographyDiffusion Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • To evaluate the relationships between both SUVmax and ADC and clinicopathological prognostic factors

    3 years

Study Arms (6)

Histologic grade

According to the modified criteria of Bloom and Richardson grading system: grade 1, 2 and 3

Axillary metastasis

Group A: axillary lymph node metastasis Group B: no axillary lymphatic metastasis

Modified Nottingham prognostic index

NPI = pathological tumour size (cm) × 0.2 + lymph node stage (1, 2 or 3) + histological grade (1, 2 or 3) The cut-off points of the index were 3.4 and 5.4 to divide patients into the good (≤3.4), moderate (3.41-5.4) and poor (\>5.4) prognostic groups

Oestrogen receptor status

Negative Positive

Progesterone receptor status

Negative Positive

HER-2 neu status

Negative Positive

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female patients with breast cancer

You may qualify if:

  • Newly diagnosis of breast cancer for which surgical intervention is planned

You may not qualify if:

  • patients received neoadjuvant chemotherapy
  • before breast surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcilar Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • AYNUR OZEN, MD

    Bagcilar Training & Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Aynur Ozen

Study Record Dates

First Submitted

September 2, 2013

First Posted

September 16, 2013

Study Start

September 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 10, 2014

Record last verified: 2014-06

Locations

TU(1)