NCT04579107

Brief Summary

Women taking part in the National Mammography Screening Program, examined at Södersjukhuset Breast Centre at Södra station in Stockholm and recalled because of suspicion of breast cancer will be invited to participate. A Contrast Enhanced Mammography will be added to the standard of care procedures for investigating a suspicion of breast cancer and blinded from each other 2 radiologists will evaluate either the Contrast Enhanced Mammography or the standard of care examinations. When comparing the potentially extra findings with Contrast Enhanced Mammography will be calculated. Potential side effects together with the patient experience will also be evaluated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
420

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2.5 years

First QC Date

October 1, 2020

Last Update Submit

November 15, 2023

Conditions

Breast Cancer

Keywords

Contrast Enhanced Mammography

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of Contrast Enhanced Mammography

    Evaluating sensitivity of Contrast Enhanced Mammography in detecting multifocality and/or contralateral breast cancer, compared to standard breast radiology work-up methods.

    1 day

Secondary Outcomes (6)

  • Specificity of Contrast Enhanced Mammography

    1 day

  • Safety of Contrast Enhanced Mammography

    30 days

  • Patient acceptance of Contrast Enhanced Mammography

    30 days

  • Tumor size assessment

    1 day

  • Mammographic density influence on the performance of Contrast Enhanced Mammography

    1 day

  • +1 more secondary outcomes

Study Arms (1)

Contrast Enhanced Mammography

OTHER

All included women go through a Contrast Enhanced Mammography added to the standard of care examinations.

Combination Product: Contrast Enhanced Mammography

Interventions

Contrast Enhanced MammographyCOMBINATION_PRODUCT

A modality for examining breast conditions which is already approved and used but the evaluation of its role in a recalled screening population is limited. Intravenous iodine contrast is given prior to the mammogram.

Contrast Enhanced Mammography

Eligibility Criteria

Age25 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Age: \>25 - \<85 years
  • Recalled after Mx screening based on abnormal mammographic findings or refered for breast cancer related symtoms
  • The woman has read, understood and signed the Informed Consent Form (ICF)

You may not qualify if:

  • Previous breast cancer
  • A breast biopsy performed within 6 weeks preceding the study
  • Recent exposure (during the last week) to iodine contrast media.
  • Pregnancy
  • Current breast feeding
  • Diagnosed with a pheochromocytoma or a paraganglioma
  • Diagnosed with myeloma or other malignant plasma cell disease
  • Diagnosed with myasthenia gravis
  • A renal failure or kidney disorder with increased risk for developing renal failure (single kidney or kidney transplanted)
  • Diabetes (other than dietary treated)
  • Heart failure or liver failure
  • Intake of potentially nephrotoxic substances (daily intake of NSAID, nephrotoxic antibiotics or nephrotoxic chemotherapy)
  • Iodine contrast allergy
  • Uncontrolled thyrotoxicosis
  • A history of severe allergy
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bröstcentrum, Södersjukhuset

Stockholm, Sweden

RECRUITING

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Per Hall, MD PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Magnus Bäcklund, MD PhD

CONTACT

+46704663164magnus.backlund@ki.se

Per Hall, MD PhD

CONTACT

+46852480000per.hall@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The added Contrast Enhanced Mammography will be evaluated by a radiologist blinded from the radiologists evaluating the standard of care examinations.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 1, 2020

First Posted

October 8, 2020

Study Start

October 1, 2021

Primary Completion

April 1, 2024

Study Completion

May 31, 2024

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

SE(1)