Supplemental Screening for Women With Extremely Dense Breast Tissue: the DENSE-2 Trial

NCT06636370 | Recruiting DMC

• 2 other identifiers: 05550412310002Nr. 2024/09
• Study Type: interventional
• Target: 36,000
• Locations: 1 country
• Sites: 1

Brief Summary

Women with extremely dense breasts (nearly all glandular and connective tissue, little fatty tissue) have a 3-6 times higher risk of breast cancer than women with very low breast density. Moreover, due to the masking effect of the dense tissue, any breast tumours present are more difficult to detect in these women. With the results of the DENSE trial, the investigators showed that among women with extremely dense breasts, a combination of MRI and mammography could detect tumours earlier than mammography only. As the implementation of MRI in the screening program induces considerable costs and capacity requirements, the Dutch Ministry of Health would like to investigate whether cheaper and acceptable alternatives can be implemented more easily. In the DENSE-2 study, proposed here, we will investigate contrast-enhanced mammography and an abbreviated form of MRI as alternatives, in a large-scale randomized trial, within the current population-based screening program.

Conditions

Breast Cancer

Keywords

breast cancer screening; extremely dense breasts; early detection; contrast-enhanced mammography; abbreviated MRI

Outcome Measures

Primary Outcomes (1)

• Interval Cancer Rate

  Measured as a breast cancer diagnosed in between two screening rounds

  0 - 3 year

Secondary Outcomes (18)

• Cancer detection rate

  0 - 3 year

• False positive rate

  0-5 year

• Participant experience with CEM - 1

  0-5 year

• Participant experience with CEM - 2

  0-5 year

• Participant experience with CEM - 3

  0-5 year

Study Arms (3)

Control

NO INTERVENTION

This group receives biennial mammography only within the current Dutch National Breast Cancer Screening program. This group will not be informed about the study (pre-randomisation design)

Contrast-enhanced Mammography (CEM)

EXPERIMENTAL

This group receives supplemental screening with CEM after a negative mammography result in the Dutch National Breast Cancer screening program

Diagnostic Test: Contrast-enhanced mammography (CEM)

Abbreviated MRI (AB-MRI)

EXPERIMENTAL

This group receives supplemental screening with AB-MRI after a negative mammography result in the Dutch National Breast Cancer Screening program

Diagnostic Test: Abbreviated MRI (AB-MRI)

Interventions

Contrast-enhanced mammography (CEM) DIAGNOSTIC_TEST

This intervention group receives supplemental screening with CEM after a negative screening result within the Dutch National Breast Cancer Screening program

Contrast-enhanced Mammography (CEM)

Abbreviated MRI (AB-MRI) DIAGNOSTIC_TEST

This intervention group receives supplemental screening with AB-MRI after a negative screening result within the Dutch National Breast Cancer Screening program

Abbreviated MRI (AB-MRI)

Eligibility Criteria

• Age: 49 Years - 72 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant in the Dutch population-based breast cancer screening program with a negative mammography result (BI-RADS classification 1 or 2).
• Extremely dense breast tissue (assessed with Quantra software, category D).
• Living in the service area (travel distance of up to 60 km) of the 15 participating hospitals.
• Absence of breast implants (Quantra cannot provide an accurate density determination for breasts with implants).
• No objection to data sharing.
• Not a participant in the DENSE trial or STREAM trial (participants in the DENSE and STREAM trials are known to the Dutch screening organization).

You may not qualify if:

• Presence of in-body metals (only for AB-MRI, this involves specific metals and is asked by telephone).
• Previous allergic reaction to the provided contrast agent.
• Renal insufficiency (glomerular filtration rate \<30 ml/min) (only for CEM, is checked for with questionnaire I and possibly renal function measurement).
• Severe claustrophobia (only for AB-MRI).
• Severe obesity (weight \>150 kg) (only for AB-MRI).

Sponsors & Collaborators

• C.H. van Gils: lead
• University Medical Center Groningen: collaborator
• Ziekenhuisgroep Twente: collaborator
• Radboud University Medical Center: collaborator
• Rijnstate Hospital: collaborator
• Zuyderland Medical Centre: collaborator
• Maastricht University Medical Center: collaborator
• Elisabeth-TweeSteden Ziekenhuis: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• Jeroen Bosch Hospital: collaborator
• Erasmus Medical Center: collaborator
• Albert Schweitzer Hospital: collaborator
• St. Antonius Hospital: collaborator
• Antoni van Leeuwenhoek Hospital: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Bevolkingsonderzoek Nederland: collaborator
• Borstkankervereniging Nederland: collaborator

Study Sites (1)

UMC Utrecht

Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Carla van Gils, Prof.

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla van Gils, Prof

CONTACT

0031-88-7568181; dense-2@umcutrecht.nl

Evelyn Monninkhof, Dr.

CONTACT

e.monninkhof@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 10, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): September 1, 2031
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

NL (1)