Gd-based Contrast Media Exposure During Breast MRI ScansNCT03393442
Evaluation of Gadolinium Deposits in Healthy Women Participating in a High Risk Screening Program for Early Breast Cancer Detection
A study testing Brain MRI scan in people with Gd-based Contrast Media Exposure During Breast MRI Scans, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Purpose: To determine whether patients at high risk to develop breast cancer having received at least 6 cumulative dosages of macrocyclic Gd-based contrast media in the context of breast cancer screening by means of contrast-enhanced MRI. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gd-based Contrast Media Exposure During Breast MRI Scans
- What is being tested?
- Brain MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 25 Nov 2017to 1 Apr 2018
- 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 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female; cumulative exposure to ≥6 dosages of macrocyclic Gd-based agents in the course of breast MRI screening for breast cancer OR no exposure to Gd-based contrast media
Who cannot join
- Previous chemotherapy; serious illness including cardiovascular and neurological diseases; contraindications to MRI; exposure to non-macrocyclic Gd-based contrast agents
Trial locations and contacts
1 site in 1 country.
Pascal A Baltzer contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Barbara I Bennani-Baiti, +43-1-40400-48180, barbara.bennani-baiti@meduniwien.ac.at
Pascal A Baltzer, +43-1-40400-48180, pascal.baltzer@meduniwien.ac.at
About this study
Purpose: To determine whether patients at high risk to develop breast cancer having received at least 6 cumulative dosages of macrocyclic Gd-based contrast media in the context of breast cancer screening by means of contrast-enhanced MRI.
Methods: Diagnostic study encompassing two arms: first, 50 patients having received ≥6 dosages of macrocyclic Gd-based contrast media in the course of MRI-based breast cancer screening will undergo brain MRI assessment for signal alterations due to Gd-deposits. The second arm consists of 50 healthy volunteers that never received Gd-based contrast agents, and undergoes the same brain MRI assessment as the patient-based arm 1 of the study. Signal intensities will be compared to assess the potential presence or absence of macrocyclic Gd-based contrast agent deposits in the brain.
Read more
In case of presence of signal alterations in arm 1 these will be further stratified by number of previously administered macrocyclic Gd-contrast agent doses.
Projected outcome: High cumulative dosages of macrocyclic Gd-based contrast agent either result or do not result in brain MRI signal alterations in healthy women participating in a high-risk screening program for the early detection of breast cancer that necessitates Gd-contrast agent enhanced breast MRI at regular intervals.
- Being tested
- Brain MRI scan
- Keywords
- Magnetic Resonance Imaging, Gd-based contrast media, Gd-deposits, brain imaging, breast cancer screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRI scanDiagnostic test
Diagnostic brain MRI scan with the purpose to detect signal changes due to brain deposits of Gd.
| Study group | Role | What they receive |
|---|---|---|
| 1. Gd-exposed subjects | Experimental | Diagnostic Test: Brain MRI scan Female subjects at high risk for breast cancer that previously underwent more than 6 Gd-based contrast enhanced MRI exams of the breast. Receives: Diagnostic Test: Brain MRI scan |
| 2. Healthy subjects | Active comparator | Diagnostic Test: Brain MRI scan Age-matched female control subjects that never received Gd-based contrast agents. Receives: Diagnostic Test: Brain MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Gd-deposit associated brain signal alterations
Evaluation of Gadolinium Deposits in Healthy Women Participating in a High Risk Screening Program for Early Breast Cancer Detection in comparison to healthy volunteers without previous Gd-based contrast media exposure - signal intensities of various brain regions measured by different MRI sequences will be evaluated
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start25 Nov 2017
- Primary completion15 Mar 2018 (estimated)
- Study completion1 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gd-based Contrast Media Exposure During Breast MRI ScansStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Female subjects exposed to Gd-based contrast media and female subjects not exposed to Gd-based contrast media will be examined by a diagnostic test (brain MRI scan) to determine the presence or absence of Gd-deposit related signal alterations in the brain.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Barbara Bennani-Baiti, Medical University of Vienna
- Investigators
- Barbara I Bennani-Baiti, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393442
- Sponsor's protocol ID
- 1724/2017
- Status last verified
- Jan 2018
- First submitted
- 3 Jan 2018
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to a lack of funding IPD cannot be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gadolinium Deposits in Healthy Women Participating in a High Risk Screening Program for Early Breast Cancer Detection
- ClinicalTrials.gov ID
- NCT03393442
- Acronym / sponsor ID
- 1724/2017
- Keywords
- Magnetic Resonance Imaging, Gd-based contrast media, Gd-deposits, brain imaging, breast cancer screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 25 Nov 2017 (actual)
- Primary completion
- 15 Mar 2018 (estimated)
- Study completion
- 1 Apr 2018 (estimated)
- First posted
- 8 Jan 2018 (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.
Purpose: To determine whether patients at high risk to develop breast cancer having received at least 6 cumulative dosages of macrocyclic Gd-based contrast media in the context of breast cancer screening by means of contrast-enhanced MRI.
Methods: Diagnostic study encompassing two arms: first, 50 patients having received ≥6 dosages of macrocyclic Gd-based contrast media in the course of MRI-based breast cancer screening will undergo brain MRI assessment for signal alterations due to Gd-deposits. The second arm consists of 50 healthy volunteers that never received Gd-based contrast agents, and undergoes the same brain MRI assessment as the patient-based arm 1 of the study. Signal intensities will be compared to assess the potential presence or absence of macrocyclic Gd-based contrast agent deposits in the brain.
In case of presence of signal alterations in arm 1 these will be further stratified by number of previously administered macrocyclic Gd-contrast agent doses.
Projected outcome: High cumulative dosages of macrocyclic Gd-based contrast agent either result or do not result in brain MRI signal alterations in healthy women participating in a high-risk screening program for the early detection of breast cancer that necessitates Gd-contrast agent enhanced breast MRI at regular intervals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Female subjects exposed to Gd-based contrast media and female subjects not exposed to Gd-based contrast media will be examined by a diagnostic test (brain MRI scan) to determine the presence or absence of Gd-deposit related signal alterations in the brain.
| Arm | Type | Receives |
|---|---|---|
| 1. Gd-exposed subjects | Experimental | Diagnostic Test: Brain MRI scanDiagnostic Test: Brain MRI scan Female subjects at high risk for breast cancer that previously underwent more than 6 Gd-based contrast enhanced MRI exams of the breast. |
| 2. Healthy subjects | Active comparator | Diagnostic Test: Brain MRI scanDiagnostic Test: Brain MRI scan Age-matched female control subjects that never received Gd-based contrast agents. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female; cumulative exposure to ≥6 dosages of macrocyclic Gd-based agents in the course of breast MRI screening for breast cancer OR no exposure to Gd-based contrast media
Key exclusion criteria (1 listed)
- Previous chemotherapy; serious illness including cardiovascular and neurological diseases; contraindications to MRI; exposure to non-macrocyclic Gd-based contrast agents
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 |
|---|---|---|
| Brain MRI scanDiagnostic brain MRI scan with the purpose to detect signal changes due to brain deposits of Gd. | Diagnostic test | 1. Gd-exposed subjects, 2. Healthy subjects |
Primary outcome
Presence of Gd-deposit associated brain signal alterations
Time frame: Immediate
Evaluation of Gadolinium Deposits in Healthy Women Participating in a High Risk Screening Program for Early Breast Cancer Detection in comparison to healthy volunteers without previous Gd-based contrast media exposure - signal intensities of various brain regions measured by different MRI sequences will be evaluated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: No. Due to a lack of funding IPD cannot be made publicly available.
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.
Pascal A Baltzer contact
Barbara I Bennani-Baiti principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain MRI scan in people with Gd-based Contrast Media Exposure During Breast MRI Scans, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 1 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 9 Jan 2018. 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 Austria. 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 Barbara I Bennani-Baiti (+43-1-40400-48180, barbara.bennani-baiti@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Gd-deposit associated brain signal alterations (time frame: Immediate). 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 9 Jan 2018.