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New treatment option for Breast Cancer
Official title Supplemental Screening for Women With Extremely Dense Breast Tissue: the DENSE-2 Trial
ClinicalTrials.gov ID: NCT06636370
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 49 to 72, women only. Healthy volunteers may be eligible.
You may be able to join 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).
- 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...
- 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).
You likely can't join if
- The additional exclusion criteria for the intervention arms are checked after randomization and recruitment (this order is due to the...
- 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...
- Severe claustrophobia (only for AB-MRI).
- Severe obesity (weight \>150 kg) (only for AB-MRI).
See the full eligibility 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...
- 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).
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 49 years to 72 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.