Clinical trial · Interventional
Low-dose Imaging Technique (LITE)
Low-dose Imaging Technique (LITE) MRI Gadavist® (Gadobutrol)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left institution due to family emergency prior to IRB approval.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-dose Imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Low-dose Imaging
- description
- 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.
- interventionNames
- Diagnostic Test: Low-dose Imaging
Primary outcomes (1)
- measure
- Low-dose Lesion Enhancement
- timeFrame
- Through study completion, an average of 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Women between the ages of 18-80 * Women with a suspected or biopsy proven enhancing lesion Exclusion Criteria: * 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
References
Publications (0)
Data not yet available