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

NCT ID: NCT06636370

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-11

Study Completion Date

2031-09-01

Brief Summary

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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.

Detailed Description

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Women with extremely dense breast tissue have a higher risk of developing breast cancer and at the same time, mammography has limited value for these women. Currently, these women are not offered supplemental screening. Therefore, the investigators of the DENSE-2 trial will study supplemental CEM and AB-MRI screening in women with extremely dense breast tissue within the population-based breast cancer screening program because these modalities are expected to have higher diagnostic accuracy than tomosynthesis and ultrasound. In addition, these modalities are expected to be less expensive and require less capacity than a full MRI protocol as examined in the DENSE trial. For both CEM and AB-MRI, no results are currently available from a prospective screening study. The DENSE-2 trial is a randomized controlled trial comparing two intervention arms (CEM \[intervention arm A\] and abbreviated MRI \[intervention arm B\]) each with mammography \[control arm C\].

Conditions

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Breast Cancer

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Control

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Contrast-enhanced Mammography (CEM)

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

Group Type EXPERIMENTAL

Contrast-enhanced mammography (CEM)

Intervention Type DIAGNOSTIC_TEST

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

Abbreviated MRI (AB-MRI)

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

Group Type EXPERIMENTAL

Abbreviated MRI (AB-MRI)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Contrast-enhanced mammography (CEM)

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

Intervention Type DIAGNOSTIC_TEST

Abbreviated MRI (AB-MRI)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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).
* Age between 49-72 years (women are invited to the Dutch screening program in the year they turn 50, so the minimum age is 49 years. The maximum age for inclusion is 72 years to ensure that women can still participate in a second round of supplemental screening).
* 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).

Exclusion Criteria

* 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).
Minimum Eligible Age

49 Years

Maximum Eligible Age

72 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role collaborator

Ziekenhuisgroep Twente

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role collaborator

Zuyderland Medical Centre

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role collaborator

Elisabeth-TweeSteden Ziekenhuis

OTHER

Sponsor Role collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role collaborator

Jeroen Bosch Hospital

UNKNOWN

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role collaborator

Albert Schweitzer Hospital

OTHER

Sponsor Role collaborator

St. Antonius Hospital

OTHER

Sponsor Role collaborator

Antoni van Leeuwenhoek Hospital

OTHER

Sponsor Role collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role collaborator

Bevolkingsonderzoek Nederland

UNKNOWN

Sponsor Role collaborator

Borstkankervereniging Nederland

UNKNOWN

Sponsor Role collaborator

C.H. van Gils

OTHER

Sponsor Role lead

Responsible Party

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C.H. van Gils

Professor Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Carla van Gils, Prof.

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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UMC Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Carla van Gils, Prof

Role: CONTACT

Phone: 0031-88-7568181

Email: [email protected]

Evelyn Monninkhof, Dr.

Role: CONTACT

Email: [email protected]

Facility Contacts

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Sophie van Grinsven, Msc.

Role: primary

Other Identifiers

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Nr. 2024/09

Identifier Type: OTHER

Identifier Source: secondary_id

05550412310002

Identifier Type: -

Identifier Source: org_study_id