Breast CancerNCT04350957
Low-dose Imaging Technique (LITE)
A study testing Low-dose Imaging in people with Breast Cancer, run by University of Chicago.
Trial summary
The purpose of this study is to compare the diagnostic accuracy of a breast MRI when using a smaller dose of contrast compared to a full dose of contrast. Each patient will be injected with a low-dose and standard dose of Gadavist® acquired on two separate days. 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
- Breast Cancer
- What is being tested?
- Low-dose Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 24 Aug 2020to 24 Aug 2020
- 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
- Women between the ages of 18-80
- Women with a suspected or biopsy proven enhancing lesion
Who cannot join
- Women with a history of adverse reactions to contrast media
- Women with GFR below 30 mL/min/1.73m2
- Women who are pregnant or breastfeeding
About this study
Official title: Low-dose Imaging Technique (LITE) MRI Gadavist® (Gadobutrol)
The purpose of this study is to compare the diagnostic accuracy of a breast MRI when using a smaller dose of contrast compared to a full dose of contrast.
Each patient will be injected with a low-dose and standard dose of Gadavist® acquired on two separate days. Both low-dose and standard-dose images for each patient will allow matched comparison for comprehensive quantitative evaluation. To evaluate these diagnostic methods we need volunteers who are willing to allow us to take a number of different MRI pictures of their breasts. The scans we are asking you to volunteer for now is for research purposes only and will have no effect on the medical care you receive from your doctors.
- Conditions
- Breast Cancer
- Being tested
- Low-dose Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose ImagingDiagnostic test
We are comparing MRI image quality for diagnostic purposes. We hope to learn whether using a lesser dose (25%) of the FDA approved contrast agent, Gadavist®, is just as effective as a standard or full dose (100%) of the same contrast in a breast MRI.
This research is being done because breast MRI's have repeatedly been shown to represent the most reliable imaging method for breast cancer screening and diagnosis, regardless of personal risk for breast cancer and radiographic breast density. However, there are growing concerns about getting frequent breast MRI examinations due to the deposition of gadolinium, a metal ion that is found in all breast MRI contrast agents. The FDA states that this deposition and retention is not known to have any long term side effects on patient. However, the researchers at the University of Chicago Medicine would like to further investigate this using a lesser dose of contrast agent than the recommended dose for breast MRI examinations.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose Imaging | Experimental | Enrolled patients will undergo two separate dynamic contrast-enhanced MRI's, one with 25% of the contrast dose and one with 100% of the contrast dose recommended by weight. During the first visit, the subject will receive 25% of the standard dose of contrast media 0.1 mM/kg will be administered at 2 mls/second followed by the acquisition of a series of DCE images. On the second visit, the subject will receive 100% of the contrast media followed by the same imaging protocol as the one subsequent to the first contrast administration. Receives: Diagnostic Test: Low-dose Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low-dose Lesion Enhancement
Readers will initially be provided with two MIP images and asked to decide on presence or absence of significant enhancement. The two MIP images will be created from the low dose images and the standard dose images respectively.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start24 Aug 2020
- Primary completion24 Aug 2020
- Study completion24 Aug 2020
Why it stopped: PI left institution due to family emergency prior to IRB approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This clinical trial has a single arm. All subjects will receive a low dose and standard dose on two separate days
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deepa Sheth, MD, Principal investigator, University of ChicagoGregory S Karczmar, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350957
- Sponsor's protocol ID
- IRB20-0528
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2020
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Imaging Technique (LITE) MRI Gadavist® (Gadobutrol)
- ClinicalTrials.gov ID
- NCT04350957
- Acronym / sponsor ID
- IRB20-0528
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution due to family emergency prior to IRB approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 24 Aug 2020 (actual)
- Study completion
- 24 Aug 2020 (actual)
- First posted
- 17 Apr 2020 (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 purpose of this study is to compare the diagnostic accuracy of a breast MRI when using a smaller dose of contrast compared to a full dose of contrast.
Each patient will be injected with a low-dose and standard dose of Gadavist® acquired on two separate days. Both low-dose and standard-dose images for each patient will allow matched comparison for comprehensive quantitative evaluation. To evaluate these diagnostic methods we need volunteers who are willing to allow us to take a number of different MRI pictures of their breasts. The scans we are asking you to volunteer for now is for research purposes only and will have no effect on the medical care you receive from your doctors.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This clinical trial has a single arm. All subjects will receive a low dose and standard dose on two separate days
| Arm | Type | Receives |
|---|---|---|
| Low-dose Imaging | Experimental | Diagnostic Test: Low-dose ImagingEnrolled patients will undergo two separate dynamic contrast-enhanced MRI's, one with 25% of the contrast dose and one with 100% of the contrast dose recommended by weight. During the first visit, the subject will receive 25% of the standard dose of contrast media 0.1 mM/kg will be administered at 2 mls/second followed by the acquisition of a series of DCE images. On the second visit, the subject will receive 100% of the contrast media followed by the same imaging protocol as the one subsequent to the first contrast administration. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women between the ages of 18-80
- Women with a suspected or biopsy proven enhancing lesion
Key exclusion criteria (3 listed)
- Women with a history of adverse reactions to contrast media
- Women with GFR below 30 mL/min/1.73m2
- Women who are pregnant or breastfeeding
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 |
|---|---|---|
| Low-dose ImagingWe are comparing MRI image quality for diagnostic purposes. We hope to learn whether using a lesser dose (25%) of the FDA approved contrast agent, Gadavist®, is just as effective as a standard or full dose (100%) of the same contrast in a breast MRI. This research is being done because breast MRI's have repeatedly been shown to represent the most reliable imaging method for breast cancer screening and diagnosis, regardless of personal risk for breast cancer and radiographic breast density. However, there are growing concerns about getting frequent breast MRI examinations due to the deposition of gadolinium, a metal ion that is found in all breast MRI contrast agents. The FDA states that this deposition and retention is not known to have any long term side effects on patient. However, the researchers at the University of Chicago Medicine would like to further investigate this using a lesser dose of contrast agent than the recommended dose for breast MRI examinations. | Diagnostic test | Low-dose Imaging |
Primary outcome
Low-dose Lesion Enhancement
Time frame: Through study completion, an average of 1 year
Readers will initially be provided with two MIP images and asked to decide on presence or absence of significant enhancement. The two MIP images will be created from the low dose images and the standard dose images respectively.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
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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.
Deepa Sheth, MD principal investigator
University of Chicago
Gregory S Karczmar, PhD principal investigator
University of Chicago
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose Imaging in people with Breast Cancer, run by University of Chicago.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 26 Apr 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low-dose Lesion Enhancement (time frame: Through study completion, an average of 1 year). 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 26 Apr 2023.