Clinical trial · Observational
MRI Gadopiclenol Enhanced Imaging of CNS Tumors
A Pilot Study of Gadopiclenol for Imaging Central Nervous System (CNS) Tumors at Point of Care Magnetic Resonance Imaging (MRI)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The sponsor backed out of the trial.
Summary
Brief summary (as posted)
The purpose of this pilot study is to compare a standard of care MRI scan to a non-standard of care MR imaging with portable (0.064 Tesla) MRI following the administration of non-SOC contrast called Gadopiclenol on 10 subjects with known brain tumors. Participants will be randomized to receive either standard MRI or portable MRI first following contrast injection
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 |
|---|---|---|---|
| Image | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CE MRI on 0.064T Scanner | Device | — | UNRESOLVED |
| Gadopiclenol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 3T Contrast Enhanced Images First
- interventionNames
- Device: CE MRI on 0.064T Scanner
- Drug: Gadopiclenol
- label
- 0.064 Contrast Enhanced Images First
- interventionNames
- Device: CE MRI on 0.064T Scanner
- Drug: Gadopiclenol
Primary outcomes (1)
- measure
- Visibility of lesions
- timeFrame
- 1 Day
- description
- Visibility of lesions and diagnostic capabilities of 0.068T MRI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Female or male adult patient (18 years and older). * Patient presenting, at the time of inclusion, with known or highly suspected focal areas of disrupted Blood Brain Barrier (BBB) due to primary or secondary tumor/s. This lesion must have been detected on a previous imaging procedure (computerized Tomography (CT) or MRI). * Patient scheduled for a routine CNS contrast-enhanced MRI examination for clinical reasons. * Patient able and willing to participate in the study. * Patient with health insurance. Exclusion Criteria * Patient presenting with acute or chronic Grade III (at least) renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73m² based on eGFR assessment on the day of each MRI. * Pregnant or breast-feeding female patient (a female patient of childbearing potential must be using a medically approved contraception method until the last study visit). * Patient with any contraindication to MRI examinations including active implants, passive implants which are MRI incompatible, and metallic foreign bodies. * Patient with known contra-indication(s) to the use or with known sensitivity to any GBCA. * Patient having received any contrast agent (MRI or CT) within 3 days prior to study gadopiclenol administration
References
Publications (0)
Data not yet available