Breast NeoplasmsDECREASNCT05181059
DLSCT for Breast Cancer Detection in Women With Dense Breasts
An observational study of Breast Neoplasms and Breast Density, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
The main objective of this project is to demonstrate the feasibility of DLSCT to detect breast cancer in women with dense breasts. Patients with locoregional advanced primary breast cancer and heterogeneously (n = 7) or extremely dense breasts (n = 7) as determined by mammography will be included in this study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Breast Density, Radiographic Image Interpretation, Computer-Assisted
- What is being tested?
- Dual-layer spectral computerized tomography (DLSCT)
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2022to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Secondary care clinic
Who may be able to join
- Diagnosis of histopathologically proven locoregional advanced primary breast cancer:
- Tumors > 5 cm (= T3) or
- Tumors with invasion of the skin or chest wall (= T4) or
- Any tumor with ≥ 4 axillary lymph nodes or ipsilateral internal mammary, infraclavicular or supraclavicular nodal involvement (= N2-3)
- Heterogeneously or extremely dense breasts as described by visual assessment on full-field digital mammograms: category C or D according to the ACR BI-RADS lexicon
Who cannot join
- History of allergic reactions to iodinated contrast agents
- Pregnancy or breast feeding
- Treatment of thyroid disease with radioactive iodine
- Use of metformin
- Creatinine clearance < 45 ml/min
- Chronic or acutely worsening renal disease
- Patients who are declared incompetent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Rijnstate Hospital
Arnhem
Carla A Meeuwis, MD, PhD, cmeeuwis@rijnstate.nl
About this study
Official title: Dual-layer Spectral Computerized Tomography for Breast Cancer Detection in Women With Dense Breasts: a Single Centre, Feasibility Study - The DECREAS Study
The main objective of this project is to demonstrate the feasibility of DLSCT to detect breast cancer in women with dense breasts.
Patients with locoregional advanced primary breast cancer and heterogeneously (n = 7) or extremely dense breasts (n = 7) as determined by mammography will be included in this study. These patients have an indication for a positron emission tomography computed tomography (PET-CT) scan to search for distant metastases. In this study the participants will undergo an additional contrast enhanced DLSCT scan to determine the feasibility of spectral CT to detect breast cancer in women with dense breasts.
- Being tested
- Dual-layer spectral computerized tomography (DLSCT)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-layer spectral computerized tomography (DLSCT)Diagnostic test
Contrast enhanced DLSCT scan using a 128-slice dual-layer detector (IQon Spectral CT, Philips Health Systems) will be performed. Patients will be placed in prone position during the DLSCT scan in order to improve the visualisation of breast tissue and comparability with MRI images. During the examination we will administer a nonionic low-osmolar iodinated contrast agent (Optiray©) in order to visualise tumor angiogenesis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual tumor conspicuity
The conspicuity of tumors will be graded on a 4-point confidence scale
Measured: On the same 1 day as the regular PET-CT scan was performed
BI-RADS score
BI-RADS score according to the ACR BI-RADS lexicon
Measured: On the same 1 day as the regular PET-CT scan was performed
Secondary outcomes (2)
Iodine enhancement
Iodine enhancement will be measured in Hounsfield Units (HU).
Measured: On the same 1 day as the regular PET-CT scan was performed
Iodine content
Iodine content will be measured mg/mL.
Measured: On the same 1 day as the regular PET-CT scan was performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura N Deden, Principal investigator, Rijnstate HospitalMaxime V.P. Schyns, MD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181059
- Sponsor's protocol ID
- NL76792.091.21
- Acronym
- DECREAS
- Status last verified
- Jan 2022
- First submitted
- 16 Dec 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-layer Spectral Computerized Tomography for Breast Cancer Detection in Women With Dense Breasts: a Single Centre, Feasibility Study - The DECREAS Study
- ClinicalTrials.gov ID
- NCT05181059
- Acronym / sponsor ID
- DECREAS / NL76792.091.21
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this project is to demonstrate the feasibility of DLSCT to detect breast cancer in women with dense breasts.
Patients with locoregional advanced primary breast cancer and heterogeneously (n = 7) or extremely dense breasts (n = 7) as determined by mammography will be included in this study. These patients have an indication for a positron emission tomography computed tomography (PET-CT) scan to search for distant metastases. In this study the participants will undergo an additional contrast enhanced DLSCT scan to determine the feasibility of spectral CT to detect breast cancer in women with dense breasts.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Secondary care clinic
Key inclusion criteria (5 listed)
- Diagnosis of histopathologically proven locoregional advanced primary breast cancer:
- Heterogeneously or extremely dense breasts as described by visual assessment on full-field digital mammograms: category C or D according to the ACR BI-RADS lexicon
Key exclusion criteria (7 listed)
- History of allergic reactions to iodinated contrast agents
- Pregnancy or breast feeding
- Treatment of thyroid disease with radioactive iodine
- Use of metformin
- Creatinine clearance < 45 ml/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-layer spectral computerized tomography (DLSCT)Contrast enhanced DLSCT scan using a 128-slice dual-layer detector (IQon Spectral CT, Philips Health Systems) will be performed. Patients will be placed in prone position during the DLSCT scan in order to improve the visualisation of breast tissue and comparability with MRI images. During the examination we will administer a nonionic low-osmolar iodinated contrast agent (Optiray©) in order to visualise tumor angiogenesis. | Diagnostic test | – |
Primary outcome
Visual tumor conspicuity
Time frame: On the same 1 day as the regular PET-CT scan was performed
The conspicuity of tumors will be graded on a 4-point confidence scale
BI-RADS score
Time frame: On the same 1 day as the regular PET-CT scan was performed
BI-RADS score according to the ACR BI-RADS lexicon
2 secondary outcomes
Iodine enhancement
Time frame: On the same 1 day as the regular PET-CT scan was performed
Iodine content
Time frame: On the same 1 day as the regular PET-CT scan was performed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura N Deden principal investigator
Rijnstate Hospital
Maxime V.P. Schyns, MD principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Breast Density, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carla M Meeuwis, MD,PhD (+31 26 378 8888, cmeeuwis@rijnstate.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual tumor conspicuity (time frame: On the same 1 day as the regular PET-CT scan was performed). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.