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Trial Title:
Supplemental Screening for Women With Extremely Dense Breast Tissue: the DENSE-2 Trial
NCT ID:
NCT06636370
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer screening
extremely dense breasts
early detection
contrast-enhanced mammography
abbreviated MRI
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Contrast-enhanced mammography (CEM)
Description:
This intervention group receives supplemental screening with CEM after a negative
screening result within the Dutch National Breast Cancer Screening program
Arm group label:
Contrast-enhanced Mammography (CEM)
Intervention type:
Diagnostic Test
Intervention name:
Abbreviated MRI (AB-MRI)
Description:
This intervention group receives supplemental screening with AB-MRI after a negative
screening result within the Dutch National Breast Cancer Screening program
Arm group label:
Abbreviated MRI (AB-MRI)
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.
Detailed description:
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].
Criteria for eligibility:
Criteria:
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:
The additional exclusion criteria for the intervention arms are checked after
randomization and recruitment (this order is due to the pre-randomization design):
- 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).
Gender:
Female
Minimum age:
49 Years
Maximum age:
72 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
UMC Utrecht
Address:
City:
Utrecht
Country:
Netherlands
Contact:
Last name:
Sophie van Grinsven, Msc.
Phone:
0031-88-7568181
Email:
dense-2@umcutrecht.nl
Start date:
October 15, 2024
Completion date:
September 1, 2031
Lead sponsor:
Agency:
C.H. van Gils
Agency class:
Other
Collaborator:
Agency:
University Medical Center Groningen
Agency class:
Other
Collaborator:
Agency:
Ziekenhuisgroep Twente
Agency class:
Other
Collaborator:
Agency:
Radboud University Medical Center
Agency class:
Other
Collaborator:
Agency:
Rijnstate Hospital
Agency class:
Other
Collaborator:
Agency:
Zuyderland Medical Centre
Agency class:
Other
Collaborator:
Agency:
Maastricht University Medical Center
Agency class:
Other
Collaborator:
Agency:
Elisabeth-TweeSteden Ziekenhuis
Agency class:
Other
Collaborator:
Agency:
Catharina Ziekenhuis Eindhoven
Agency class:
Other
Collaborator:
Agency:
Jeroen Bosch Hospital
Agency class:
Other
Collaborator:
Agency:
Erasmus Medical Center
Agency class:
Other
Collaborator:
Agency:
Albert Schweitzer Hospital
Agency class:
Other
Collaborator:
Agency:
St. Antonius Hospital
Agency class:
Other
Collaborator:
Agency:
Antoni van Leeuwenhoek Hospital
Agency class:
Other
Collaborator:
Agency:
Amsterdam University Medical Centre, VUmc Site
Agency class:
Other
Collaborator:
Agency:
Bevolkingsonderzoek Nederland
Agency class:
Other
Collaborator:
Agency:
Borstkankervereniging Nederland
Agency class:
Other
Source:
UMC Utrecht
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06636370
