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Added Value of Contrast Enhanced Spectral Mammography, CESM. A Pilot Study.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03402529
Recruitment Status : Completed
First Posted : January 18, 2018
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Region Skane

Study Description
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Brief Summary:

Introduction: To avoid unnecessary mastectomies and reoperations a correct size assessment of malignant lesions in breast is required. Sometimes a supplementary MRI is therefore recommended. However, at our unit MRI is not easily available. Contrast enhanced spectral mammography (CESM) has in smaller studies been shown to be equal to MRI regarding sensitivity and specificity. Size assessment using contrast-based modalities as CESM has also been shown to be significantly more accurate than using mammography. Prospective randomized studies using CESM are lacking.

Aim: The aim of the study is to evaluate the added value of CESM in diagnostics of breast cancer and choice of operation; partial mastectomy or mastectomy.

A pilot study of 50 patients will be conducted to prepare for a larger prospective randomized study.

Method: Patients found with breast cancer after diagnostics with mammography, ultrasound and core biopsy, and whom are recommended primary surgery, will be enrolled in the study. A supplementary examination with CESM will be performed. Preoperative extent of the malignant lesions are estimated with each modality and is later compared with the extent measured in post-operative PAD. Data on weight, length, age at menopaus, use of contraceptive pills, HRT or endocrine therapy, breast volume and density is collected, as well as data of diagnosis (ductal or lobular carcinoma), surrounding DCIS, histological grade, ER, PgR, Her2 expression and Ki67 index.

In this pilot study sensitivity and specificity for each modality is calculated. Multivariate analysis will be performed regarding influential factors. Pearson correlation coefficient will be calculated for each modality regarding size assessment of the malignant lesions in comparison with definitive PAD.


Condition or disease Intervention/treatment Phase
Breast Cancer Diagnostic Test: Contrast Enhanced Spectral Mammography Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Added Value of Contrast Enhanced Spectral Mammography, CESM in Diagnostics and Size Estimation of Malignant Lesions in Breast. A Pilot Study.
Actual Study Start Date : November 28, 2017
Actual Primary Completion Date : October 19, 2018
Actual Study Completion Date : October 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arms and Interventions
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Arm Intervention/treatment
CESM Diagnostic Test: Contrast Enhanced Spectral Mammography
Pilot study


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with change of treatment [ Time Frame: 1 month ]
    Mastectomy instead of partial mastectomy, neo-adjuvant chemotherapy instead of primary surgery


Secondary Outcome Measures :
  1. size assessment of malignant lesions [ Time Frame: 2 months ]
    correlation with definitive PAD


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Most breast cancers occur in women. Male breast parenchyma is very small. Not suitable to examine by contrast enhanced spectral mammography in this study
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with breast cancer and whom are planned for primary surgery
  • Signed informed consent

Exclusion Criteria:

  • Ongoing pregnancy
  • Ongoing lactation
  • Allergy against iodine contrast
  • Treatment with metformin (against diabetes)
  • Renal failure
  • Hyperthyroidism
  • Severe heart condition
  • Myasthenia gravis
  • Implants
  • Inability to understand study information
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402529


Locations
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Sweden
Department of Surgery
Lund, Sweden, 221 85
Sponsors and Collaborators
Region Skane
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03402529    
Other Study ID Numbers: 2017/505
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Region Skane:
Contrast Enhanced Spectral Mammography