Safety and diagnostic Efficacy of Mangoral in Patients with abnormal liver cells and reduced kidney functio

Phase 1

• Conditions: MRI 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]

• Registration Number: EUCTR2019-001599-12-IT
• Lead Sponsor: Ascelia Pharma AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 197

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
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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.
11.Patients who are unable to comply with the study requirements including follow-up procedures.
12.Patients with known portosystemic shunts.
13.Patients with encephalopathy.
14.Patients with neurodegenerative disorders.
15.Patients with acute neurological disorders.
16.Patients with hemochromatosis, iron deficiency anemia, or are on iron therapy within 14 days prior to the Baseline Visit.
17.Patients receiving blood transfusion within 14 days prior to the Baseline Visit.
18.Patients who cannot fast for 8 hours.
19.Patients who cannot undergo MRI due to MRI incompatible pacemaker, metal implants, or other MRI contraindications.
20.Patients with known inherited disorders of manganese metabolism.
21.Patients with known pheochromocytoma.
22.Patients with history of surgical/other interventional procedures or conditions which may interfere with absorption of Mangoral (e.g. small bowel obstruction, gastric bypass, gastric resection).
23.Patients who have been institutionalized by official or court order and therefore are not completely free in their decision making process.
24.Patients dependent on the sponsor, investigators, personnel of the trial site or any other individual, whose willingness to volunteer may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified