NCT03402529

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable breast-cancer

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

November 28, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2018

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

December 4, 2017

Last Update Submit

January 17, 2019

Conditions

Breast Cancer

Keywords

Contrast Enhanced Spectral Mammography

Outcome Measures

Primary Outcomes (1)

  • Number of participants with change of treatment

    Mastectomy instead of partial mastectomy, neo-adjuvant chemotherapy instead of primary surgery

    1 month

Secondary Outcomes (1)

  • size assessment of malignant lesions

    2 months

Study Arms (1)

CESM

OTHER
Diagnostic Test: Contrast Enhanced Spectral Mammography

Interventions

Contrast Enhanced Spectral MammographyDIAGNOSTIC_TEST

Pilot study

CESM

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMost breast cancers occur in women. Male breast parenchyma is very small. Not suitable to examine by contrast enhanced spectral mammography in this study
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery

Lund, 221 85, Sweden

Location

Related Publications (1)

  • Ahsberg K, Gardfjell A, Nimeus E, Rasmussen R, Behmer C, Zackrisson S, Ryden L. Added value of contrast-enhanced mammography (CEM) in staging of malignant breast lesions-a feasibility study. World J Surg Oncol. 2020 May 21;18(1):100. doi: 10.1186/s12957-020-01865-0.

    PMID: 32438917DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2017

First Posted

January 18, 2018

Study Start

November 28, 2017

Primary Completion

October 19, 2018

Study Completion

October 19, 2018

Last Updated

January 18, 2019

Record last verified: 2019-01

Locations

SE(1)