The purpose of the study is to provide comparative analysis of breast imaging modalities of BCT (nu:view) compared to MRI.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to demonstrate non-inferiority of CE-BCT with CE-MRI
in the BI-RADS detection at the lesion level in the diagnosis of
(i) inconclusive findings in conventional imaging or
(ii) preoperative staging or
(iii) evaluation of therapy response in the neoadjuvant chemotherapy setting or
(iv) occult primary breast carcinoma or
(v) prosthesis imaging or
(vi) screening of women with familial increased risk for the development of
breast cancer or
(vii) finding the cause of hemorrhagic nipple discharge or
(viii) axillary lymph node metastasis suspected to originate from breast
tissue.
Secondary outcome
The secondary objective is to collect data for comfort of CE-BCT and CE-MRI
using a patient questionnaire of closed questions.
Background summary
The diagnostic quality of MRI of the breast has made this method a gold
standard in the imaging of senologic lesions. Low-dose dedicated breast CT
(BCT) with single photon-detection (nu:view, developed by AB-CT - Advanced
Breast-CT GmbH) has emerged as a fully 3D imaging modality that uses ionizing
radiation comparable to 2D mammography and has its intended use in helping with
diagnosis in diagnostic breast imaging.
The investigation is designed as a prospective non-randomized intra-individual
cohort procedure comparison between the imaging platforms, nu:view and MRI.
Across 3 hospital-based study sites in two countries, study participants
(patients who meet study criteria and have consented) sequentially receive
nu:view imaging and, with a delay of up to one week (preferably on the same
day), MRI imaging. At both times, patients receive contrast agent. Images
generated from breasts are evaluated by three independent radiologists and
their scores and interpretations are statistically evaluated. The research aim
is to demonstrate non-inferiority of BCT compared with MRI in major indications
of MRI for breast diagnostics.
The perceived gain in the study is to generate data on clinical performance of
the BCT device nu:view and on the procedure that could be supportive of a
tailored use of nu:view in patients with major indications of MRI for breast
diagnostics.
Study objective
The purpose of the study is to provide comparative analysis of breast imaging
modalities of BCT (nu:view) compared to MRI.
Study design
Prospective non-randomized intra-individual multicenter, multinational cohort
comparison of the diagnostic quality of contrast enhanced (CE) breast CT to CE
MRI in major indications of MRI for breast diagnostics.
Study burden and risks
The following adverse events (risks) have been described with the injection of
contrast-enhancing agents for CT and MRI examinations:
- Allergic reactions up to and including anaphylactic shock.
The contrast agent that is to be administered to you is a common X-ray contrast
agent that is used millions of times every day all over the world. The
administration of this contrast medium carries certain risks of side effects.
In principle, an allergic reaction to the contrast medium is possible. Patients
with a known allergy to X-ray contrast media (this must be distinguished from
allergies to MR contrast media!) cannot be included in the study.
However, allergic symptoms can also develop for the first time in people with
no known allergy. These can correspond to harmless symptoms that do not require
treatment, such as palpitations or a skin rash. These occur in about 2.5% of
cases. Extremely rarely (in approx. 0.0003% of cases), complications requiring
treatment such as shortness of breath or cardiovascular arrest can occur. In
such cases, expert emergency care is of course provided.
- Kidney damage with contrast medium-induced nephropathy (non-inflammatory
disease of the kidneys)
In principle, the contrast medium can damage kidney function. However, this is
only to be feared if the kidney function is already damaged. You will therefore
be checked for kidney function by a laboratory test before the examination as
part of the clinical routine.
- Hyperthyroidism (hyperthyroidism) to thyrotoxicosis (acute exacerbation of
hyperthyroidism) in patients with existing hyperthyroidism.
As the contrast medium contains iodine, your thyroid function will be checked
in advance by a laboratory test as part of the routine clinical procedure.
- Extra-venous injection with infection, i.e. the vein was not hit properly
during the injection and the contrast medium was injected into the tissue,
which can then become inflamed.
The contrast medium is given via a previously inserted venous indwelling
cannula on the arm (venous access, "brown cannula"). Accidental leakage of the
contrast medium from the vessel (extravasation) is conceivable, but can be
largely avoided by good placement and testing with saline solution by the
doctor.
CT (computer tomography) is always associated with a low radiation exposure.
The radiation exposure is about half the dose you receive annually from natural
radiation sources.
- The level of risk (in terms of the approximate additional risk of cancer to
an adult from the scan) to the breast from CT scanning at an effective dose of
about 0.5-0.9 mSv as used in this study can be considered "very low risk" (1 in
100,000-1 in 10,000).
The MRI machine works with a strong magnetic field, which is why wearers of a
pacemaker, for example, may be excluded from this examination method. Possible
risks can also be:
- Feeling warm, cold or tingly
- headache
- General feeling of discomfort
- Skin irritation
- In some cases, MRI contrast media also cause allergic reactions.
However, some people do not tolerate the contrast medium so well. These are
mainly patients with kidney dysfunction. They excrete the contrast medium only
poorly. Therefore, the doctor always checks the patient's kidney function
before administering the contrast medium.
Henkestraße 91
Erlangen 91052
DE
Henkestraße 91
Erlangen 91052
DE
Listed location countries
Age
Inclusion criteria
1. Sex: female
2. Age: at least 18 years
3. Inconclusive findings in conventional imaging or preoperative staging or
evaluation of therapy response in the neoadjuvant chemotherapy setting or
imaging of the breast after breast-conserving therapy or prosthesis imaging or
screening of women with hereditary or finding the cause of hemorrhagic nipple
discharge or familial increased risk for the development of breast cancer or
axillary lymph node metastasis suspected to originate from breast tissue
4. Persons able and willing to understand and sign informed consent form
Exclusion criteria
1. Known pregnancy or breastfeeding
2. Presence of BRCA1 or BRCA2 allele
3. Insufficient renal function (MDRD)
4. Dysfunction of the thyroid gland (TSH degradation)
5. Known allergy or intolerance against iodine-containing contrast enhancing
agents or MRI contrast enhancing agents
6. Patients with paramagnetic or magnetic material inside the breast,
claustrophobia and other exclusion criteria for MRI
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05989022 |
| CCMO | NL84097.058.23 |