A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients with Known or Suspected Focal Liver Lesions and Severe Renal Impairment - SPARKLE

Ascelia Pharma AB0 sites197 target enrollmentJune 17, 2021

ConditionsMRI in terms of visualization of detected focal liver lesions in patients with known or Suspected focal liver lesions and severe renal impairment MedDRA version: 22.1Level: LLTClassification code 10028049Term: MRISystem Organ Class: 100000004848 Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: MRI in terms of visualization of detected focal liver lesions in patients with known or Suspected focal liver lesions and severe renal impairment
Sponsor: Ascelia Pharma AB
Enrollment: 197
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 17, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Ascelia Pharma AB

Eligibility Criteria

Inclusion Criteria

•1\.Patients who have been fully informed and have personally signed and dated the informed consent.
•2\.Male and female patients 18 years and older.
•3\.Patients who have known or suspected focal liver lesions based on medical history and previous laboratory and/or imaging examinations.
•4\.Patients with severe renal impairment (estimated glomerular filtration rate \[eGFR] \< 30 mL/min/1\.73 m2\) measured within the screening period, or patients with an increase in serum creatinine \= 0\.3 mg/dL within 48 hours or \= 50% within 7 days;
•5\.Female patients who are not of childbearing potential, or female patients who are of childbearing potential but are using highly effective contraception (including hormonal contraceptives, such as combined oral contraceptives, patch, vaginal ring, injectables, and implants, intrauterine device, intrauterine hormone\-releasing system, vasectomized partner, and tubal ligation) or practicing sexual abstinence (only accepted if this is the usual and preferred lifestyle of the patient), and have a negative urine or serum pregnancy test within 24 hours prior to administration of contrast agent.
•6\.Sexually active male patients (who are not vasectomized) must be willing to use condoms after administration of Mangoral until the last follow\-up visit.
•7\.Patients who agree to comply with all study procedures as outlined within the study protocol and informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•1\.Patients who have received any investigational drug or were treated with an investigational device within 6 weeks prior to the Baseline Visit.
•2\.Patients who have received any MRI contrast media within 6 weeks prior to Baseline Visit or are scheduled to receive any other contrast medium other than Mangoral before the last study visit.
•3\.Patients who have previously been enrolled in the study and underwent Mangoral\-enhanced MRI.
•4\.Patients who are clinically unstable or have an acute illness; i.e. the underlying clinical condition is such that clinically relevant changes in condition can reasonably be anticipated during the study period.
•5\.Patients with moderate or severe hepatic impairment (according to Child\-Pugh score B or C).
•6\.Patients currently requiring dialysis or likely to require dialysis during the course of the clinical trial except designated dialysis patients included in the PK subgroup.
•7\.Patients scheduled for surgery before the last study visit.
•8\.Pregnant or lactating women.
•9\.Patient with history of severe allergies (e.g. anaphylaxis, respiratory difficulty).
•10\.Patients with known hypersensitivity/previous allergic reactions, to manganese or any other compounds/excipients in Mangoral.