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BI-RADS 4NCT02798562

Evaluation of the High-resolution, Contrast Enhanced Low-dose Breast-CT

A study testing Native and dynamic contrast-enhanced CT in people with BI-RADS 4 and BI-RADS 5, run by RWTH Aachen University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is the clinical establishment of a native and contrast-enhanced computer tomography of the breast. The early detection of breast cancer is still a great challenge. Read more about this study

Who is it for?
Ages 40 years and older, women only
Conditions the study is for
BI-RADS 4, BI-RADS 5, BI-RADS 6
What is being tested?
Native and dynamic contrast-enhanced CT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
No sites listed yet
Study dates
Jan 2017to Jan 2019
Phase
Interventional
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 40 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sub Study 1:
  • patients with mammographic or sonographic validated Breast Imaging Reporting and Data System (BI-RADS)-4 or BI-RADS-5-result or in BI-RADS-6-situation, i.e. with an already reliable carcinoma by punch biopsy, for which a clinical indication for a mamma-MRI consists.
  • Age >= 40
  • maintained renal function (MDRD with GFR >= 60 ml/min/1,73m²)
  • normal thyroid function, no clinical indication for an endocrine autonomy, normal TSH (not older than 8 weeks)
  • Persons which are able to give written consent and are aware of the nature, meaning and extent of the study
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  • signed informed consent
  • Substudy 2:
  • patients with a doubtful and suspect clinical or mammographic or sonographic result (BI-RADS 3, 4a, 4b, 4c, 5) as well as patients with a reliable carcinoma by punch biopsy (BI-RADS 6), patients with high risk of breast cancer for which a clinical indication for a mamma-MRI consists.
  • Age >= 40
  • maintained renal function (MDRD with GFR >= 60 ml/min/1,73m²)
  • normal thyroid function, no clinical indication for an endocrine autonomy, normal TSH (not older than 8 weeks)
  • Persons which are able to give written consent and are aware of the nature, meaning and extent of the study
  • signed informed consent

Who cannot join

  • Substudy 1:
  • Pregnancy or lactation
  • Women with child-bearing potential without sufficient contraception
  • Age <40 years
  • Women with proven pathogenic Breast Cancer (BRCA) 1-mutation or heterozygote risk (>= 25%)
  • Hospitalization of patient ordered by the court or local authorities
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  • Relationship of dependence or employment to sponsor or investigator
  • additionally the following criteria apply, if conducting the dynamic contrast-enhanced breast-CT
  • signs of a renal insufficiency (GFR < 60ml/min/1,73m²)
  • clinical signs or signs of the labor chemistry for endocrine autonomy (increase of TSH)
  • Patients with known allergies or intolerance reactions grade II or higher to contrast medium containing iodine
  • Substudy 2:
  • Pregnancy or lactation
  • Women with child-bearing potential without sufficient contraception
  • Age <40 years
  • Women with proven pathogenic BRCA 1-mutation or heterozygote risk (>= 25%)
  • Hospitalization of patient ordered by the court or local authorities
  • Relationship of dependence or employment to sponsor or investigator
  • additionally the following criteria apply, if conducting the dynamic contrast-enhanced breast-CT:
  • end stage or advanced renal insufficiency
  • clinical signs or signs of the labor chemistry for endocrine autonomy (increase of TSH)
  • Patients with known allergies or intolerance reactions grade II or higher to contrast medium containing iodine

Trial locations and contacts

No sites are listed yet.

Verena Deserno, Dipl.-Biol., M.A. contact

+49 241 80-80092

vdeserno@ukaachen.de

About this study

The aim of this study is the clinical establishment of a native and contrast-enhanced computer tomography of the breast. The early detection of breast cancer is still a great challenge. Even though the implementation of the digital mammography combined with the mandatory screening-programs lead to significant improvements, sensitivity and specificity of these examinations need to be clearly classified as improvable. Generally, it is stated that the necessary transit from 2-D projected images to 3-D tomography will be crucially advantageous as magnetic resonance imaging has already shown. Similar or even major advantages can be expected by new approaches regarding CT with very high local resolution, better than 100µm in 3D and lower dose, under 5 Milligray (mGy), as demanded for a screening. A device that meets these demands and is also applicable for dynamic scans after intravenous administration of a contrast agent, has been developed with the support by the European Union (EU), German Research Foundation (DFG) and Federal Ministry of Education and Research (BMBF). Publications on technical and experimental results are already available. An evaluation in the clinical use is missing yet. The primary aim of this study is to evaluate systematically the performance of the native and dynamic, contrast-enhanced CT of the breast.

Being tested
Native and dynamic contrast-enhanced CT
Keywords
low dose CT, contrast-enhanced, breast cancer screening, computer tomography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Native and dynamic contrast-enhanced CTDevice

Study groups in NCT02798562
Study groupRoleWhat they receive
Native and dynamic contrast-enhanced CTExperimentalPatients will undergo a native high-resolution and a dynamic contrast-enhanced CT, both sides respectively.
Receives: Device: Native and dynamic contrast-enhanced CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sub-Study 1: comparison of a-posteriori sensitivity using the native, contrast-enhanced or dynamic contrast-enhanced breast CT.

    By using the images diagnostic criteria for identification and characterization of the pathologic and physiologic changes of the female breast will be elaborated.

    Measured: 2 years

Secondary outcomes (5)

  1. Comparison of biological value of the diagnosed carcinoma in dependence with its detection mode.

    Detection mode means the prospective visibility of a carcinoma in one or more independent imaging methods, respectively.

    Biological value will be calculated by amount of high and intermediate grade vs. low grade lesions, status of Ki-67 values, distribution of luminal a, luminal b, Her2/neu and basal, distribution of receptor status

    Measured: 2 years

  2. Substudy 2: sensitivity of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures

    Measured: 2 years

  3. Sub-study 2: specificity of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures

    Measured: 2 years

  4. Substudy 2: Positive Predictive Value (PPV) of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures

    Measured: 2 years

  5. Substudy 2: Negative Predictive Value (NPV) of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionJan 2019 (estimated)
  4. Study completionJan 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02798562
Sponsor's protocol ID
15-135
Status last verified
Jun 2016
First submitted
3 Jun 2016
Last updated
16 Jun 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Weigel M, Vollmar SV, Kalender WA. Spectral optimization for dedicated breast CT. Med Phys. 2011 Jan;38(1):114-24. doi: 10.1118/1.3523599.

    PubMed 21361181

  • Nowak T, Hupfer M, Althoff F, Brauweiler R, Eisa F, Steiding C, Kalender WA. Time-delayed summation as a means of improving resolution on fast rotating computed tomography systems. Med Phys. 2012 Apr;39(4):2249-60. doi: 10.1118/1.3697533.

    PubMed 22482646

  • Beister M, Kolditz D, Kalender WA. Iterative reconstruction methods in X-ray CT. Phys Med. 2012 Apr;28(2):94-108. doi: 10.1016/j.ejmp.2012.01.003. Epub 2012 Feb 10.

    PubMed 22316498

  • Kuhl C, Weigel S, Schrading S, Arand B, Bieling H, Konig R, Tombach B, Leutner C, Rieber-Brambs A, Nordhoff D, Heindel W, Reiser M, Schild HH. Prospective multicenter cohort study to refine management recommendations for women at elevated familial risk of breast cancer: the EVA trial. J Clin Oncol. 2010 Mar 20;28(9):1450-7. doi: 10.1200/JCO.2009.23.0839. Epub 2010 Feb 22.

    PubMed 20177029

  • Kuhl CK. The "coming of age" of nonmammographic screening for breast cancer. JAMA. 2008 May 14;299(18):2203-5. doi: 10.1001/jama.299.18.2203. No abstract available.

    PubMed 18477789

  • Kuhl CK, Schrading S, Bieling HB, Wardelmann E, Leutner CC, Koenig R, Kuhn W, Schild HH. MRI for diagnosis of pure ductal carcinoma in situ: a prospective observational study. Lancet. 2007 Aug 11;370(9586):485-92. doi: 10.1016/S0140-6736(07)61232-X.

    PubMed 17693177

Questions about this trial

What is this clinical trial studying?

A study testing Native and dynamic contrast-enhanced CT in people with BI-RADS 4 and BI-RADS 5, run by RWTH Aachen University.

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 14 inclusion and 22 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 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

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 Verena Deserno, Dipl.-Biol., M.A. (+49 241 80-80092, vdeserno@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sub-Study 1: comparison of a-posteriori sensitivity using the native, contrast-enhanced or dynamic contrast-enhanced breast CT. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02798562, which also lists 6 linked publications.

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 16 Jun 2016.

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