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Status unknownNCT01597999Updated Jan 23, 2013

Benefits of Breast MRI for Predicting of Histopathologic Cell Type of Small Breast Cancer

A Phase 4 interventional study of MRI in Invasive Breast Cancer, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-23.

Sponsored by Mahidol University · Phase 4, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jan 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
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Study summary

This study examines the additional benefits of magnetic resonance imaging (MRI) with Gadovist in early breast cancer with poor prognostic features.

Read the detailed description

Dedicated Contrast-enhanced Magnetic Resonance Imaging (DCE-MRI)

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Conditions studied

  • Invasive Breast Cancer

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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 60 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with invasive ductal carcinoma
  • Patients undergoing DCE-MRI scan which are assessed according to BI-RADS lexicon
  • Breast cancer patients with pathological diagnosed invasive ductal carcinoma with hormonal receptor (ER, PR and HER-2) response
  • Patients who have signed on informed consent form Patients will undergo MRI imaging and the physicians will practice according to practice guidelines.

Exclusion criteria

Exclusion Criteria:

  • Patients under 18 years old or during pregnancy
  • Patients with MRI's contraindications e.g. patients with cardiac pacemaker or are allergic to MRI contrast agent Patients with unstable clinical abnormality and might get unexpected clinical treatment
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Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Other
    No treatment

    Accuracy of magnetic resonance imaging (MRI) in predicting aggressiveness of early breast cancer according to molecular subtypes identified by ER PR and HER-2 status ( Additional benefits of magnetic resonance imaging (MRI) with Gadovist in early breast cancer with poor prognostic features )

    Radiation: MRI

Interventions

  • RadiationMRI

    magnetic resonance imaging (MRI) with Gadovist in early breast cancer with poor prognostic features

    Also known as: Magnetic Resonance Imaging

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What researchers measure

Primary outcomes

  1. study the benefits of DCE-MRI using Gadovist in prognostic determination of early invasive breast cancer

    The benefits of breast tumor diagnosis from DCE-MRI in early invasive breast cancer with poor prognostic features

    Time frame: 1 year

Secondary outcomes

  1. ascertain the accuracy of pre-operative DCE-MRI in terms of detection and characterization of breast cancer, as compared to tissue biopsy.

    The comparision between DCE-MRI radiological features in early invasive breast cancer with poor prognostic features and early invasive breast cancer with good prognostic features To ascertain the accuracy of pre-operative DCE-MRI in terms of detection and charecterization of breast cancer, as compared to tissue biopsy

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • Faculty of Medicine Siriraj Hospital
    Bangkoknoi, Bangkok 10700, Thailand
    • Dr.Pornpim Korpraphong, Assist.Prof. · Contact · pfuang@yahoo.com · 662-4197000
    • Dr.Pornpim Korpraphong, Assist.Prof. · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01597999
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
May 15, 2012
Start date
Feb 2011
Primary completion
Jul 2012
Completion
Dec 2013 (estimated)
Last update
Jan 23, 2013

Study contacts

Dr.Pornpim Korpraphong, Assist.Prof.
Contact
pfuang@yahoo.com
6624197000 ext. 9039
Pornpim Korpraphong, M.D.
principal investigator · Mahidol University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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