Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function

Severe Renal Impairment Clinical Trial

— SPARKLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119843
• Other study ID #: ASC-Man-P016
• Secondary ID: 11-3429
• Status: Completed
• Phase: Phase 3
• Start date: February 19, 2020
• Est. completion date: February 27, 2023

Study information

• Verified date: March 2024
• Source: Ascelia Pharma AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment. The diagnostic efficacy of Mangoral will be assessed in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.

Description:

The overall objective of this multicenter, open-label, study is to evaluate the safety and diagnostic efficacy of Mangoral in participants with known or suspected focal liver lesions and severe renal impairment. Study treatment is a single oral dose of Mangoral (800 mg manganese chloride [II] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3). Adult male and female participants with severe renal impairment or acute kidney injury and who are being evaluated for known or suspected focal liver lesions will be included. Primary diagnostic efficacy in terms of visualization of detected lesions will be evaluated centrally by 3 independent readers. Study MRIs will also be evaluated by the on-site radiologists for the assessment of secondary objectives and for clinical purposes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: February 27, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female participants 18 years and older.

• Known or suspected focal liver lesions based on medical history and previous laboratory and/or imaging examinations.

• Severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m^2) based on medical history and previous laboratory examinations, at least once, within the last 3 months prior to the Baseline Visit, or participants with an increase in serum creatinine = 0.3 mg/dL within 48 hours or = 50% within 7 days prior to the Baseline Visit.

Exclusion Criteria:

• Participants with simple liver cysts only.

• Any investigational drug or device within 6 weeks prior to the Baseline Visit.

• Any magnetic resonance imaging (MRI) contrast media within 6 weeks prior to Baseline Visit or scheduled to receive any contrast medium before the last study visit.

• Participants with severe hepatic impairment (according to Child-Pugh score C).

• Participants scheduled for surgery before last study visit.

• Participants with encephalopathy / neurodegenerative or acute neurological disorders.

• Participants with hemochromatosis.

Related Conditions & MeSH terms

• Known or Suspected Focal Liver Lesions
• Renal Insufficiency
• Severe Renal Impairment

Intervention

Drug:
• Mangoral
800 mg manganese chloride [II] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3

Locations

Country	Name	City	State
Argentina	Centro Rossi Body Imaging	Buenos Aires
Argentina	Sanatorio Allende Nueva Córdoba	Cordoba
Argentina	Fundación Intecnus	San Carlos De Bariloche	Río Negro
Colombia	Clínica Universitaria Colombia	Bogotá	Cundinamarca
Colombia	Sociedad de Cirugía de Bogotá - Hospital de San José	Bogotá	Cundinamarca
Colombia	Hospital Pablo Tobon Uribe	Medellín	Antioquia
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Universitätsklinikum Frankfurt Institut für Diagnostische und Interventionelle Radiologie	Frankfurt
Germany	Universitätsmedizin Göttingen	Göttingen
Germany	Städtisches Klinikum KarlsruheDiagnostische und interventionelle Radiologie	Karlsruhe
Germany	Universitättsklinikum Schleswig-Holstein/Campus KielKlinik für Radiologie und Neuroradiologie	Kiel
Germany	Klinik und Poliklinik für Radiologie Klinikum der Universität München LMU Campus	Munich
Germany	Institut für Röntgendiagnostik	Regensburg
Italy	Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola-Malpighi	Bologna
Italy	Azienda Socio Sanitaria Territoriale (ASST)	Milano	Lombardy
Italy	Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda	Milano
Italy	Istituto Nazionale Tumori IRCCS Fondazione G. Pascale	Napoli
Italy	Ospedale del Mare	Napoli
Italy	Università Cattolica del Sacro Cuore	Roma
Italy	Azienda Ospedaliero-Universitaria Policlinico Umberto I	Rome
Italy	Ospedale di Belcolle	Viterbo
Mexico	Panamerican Clinical Research - Cuernavaca Rio Mayo	Cuernavaca
Mexico	Panamerican Clinical Research Mexico	Guadalajara
Mexico	Panamerican Clinical Research - Querétaro Avenida Paseo de la República	Querétaro
Poland	Szpital Uniwersytecki nr 1 im. Dr A. Jurasza, Wydzial Katedra i Zaklad Radiologii i Diagnostyki Obrazowej	Bydgoszcz
Poland	Szpital Uniwersytecki w Krakowie Zaklad Diagnostyki Obrazowej CUMRiK Ul	Kraków
Poland	EuroMedis Sp. z o.o.	Szczecin
Russian Federation	Altay Regional Oncology Dispencery	Barnaul
Russian Federation	State Institution of Healthcare "Regional Oncology Dispensary"	Irkutsk
Russian Federation	A.V. Vishnevsky Institute of Surgery	Moscow
Russian Federation	National Medical Research Radiology Center Named After Herzen	Moscow
Russian Federation	Scientific and Research Institute of Oncology named after N.N. Blokhin	Moscow
Russian Federation	JSC "Avicenna"	Novosibirsk
Russian Federation	State Institution of Healthcare of Omsk region	Omsk
Russian Federation	SBIH of Pskov Regional Clinical Oncologic Dispensary	Pskov
Russian Federation	LLC "Clinica YZI 4D"	Pyatigorsk
Russian Federation	N.N. Petrov Research Institute of Oncology	Saint Petersburg
Russian Federation	Saint-Petersburg State Budgetary Healthcare Institution	Saint Petersburg
Russian Federation	Smolensk Clinical Hospital	Smolensk
Russian Federation	State Autonomous Healthcare Institution of the Tyumen Region	Tyumen
Sweden	Karolinska University Hospital Huddinge	Stockholm
Turkey	Hacettepe University Medical Faculty Hospital	Ankara
Turkey	Ege University Medical Faculty Hospital	Bornova	Izmir
Turkey	Istanbul Üniversitesi - Istanbul Tip Fakültesi	Istanbul
Turkey	Kocaeli University	Izmit	Kocaeli
Turkey	Erciyes University Medical Faculty Hospital	Melikgazi	Kayseri
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Boston University Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	PanAmerican Clinical Research LLC	Brownsville	Texas
United States	Duke University	Durham	North Carolina
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of California at Los Angeles Ronald Reagan Medical Center	Los Angeles	California
United States	University of Wisconsin - Madison	Madison	Wisconsin
United States	Schiff Center for Liver Diseases	Miami	Florida
United States	Saint Louis University	Saint Louis	Missouri
United States	Mayo Clinic - Arizona	Scottsdale	Arizona
United States	University of Washington Medical Center	Seattle	Washington
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Ascelia Pharma AB

Countries where clinical trial is conducted

United States,  Argentina,  Colombia,  Germany,  Italy,  Mexico,  Poland,  Russian Federation,  Sweden,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint is the visualization of detected focal liver lesions in combined MRI (CMRI, Mangoral-enhanced MRI plus unenhanced MRI) as compared to unenhanced MRI.	Visualization will be measured by 2 co-primary variables: lesion border delineation and lesion contrast compared to liver background. Central reading sessions by 3 independent readers for all 3 parts (CMRI, Mangoral-enhanced MRI plus unenhanced MRI). There will be a 2-weeks gap between read parts to reduce recall bias.	1 year
Secondary	Number of lesions detected by each MRI method (unenhanced MRI, Mangoral-enhanced MRI, and CMRI.)	Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination	1 year
Secondary	Visualization of focal liver lesions in Mangoral-enhanced MRI as compared to unenhanced MRI	Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination	1 year
Secondary	Confidence in lesion detection separately in unenhanced MRI, Mangoral-enhanced MRI, and CMRI	Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination	1 year
Secondary	Confidence in lesion localization separately in unenhanced MRI, Mangoral-enhanced MRI, and CMRI	Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination	1 year
Secondary	Lesion dimensions: longest diameter of largest and smallest lesion	Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination	1 year
Secondary	Quantitative assessments for up to 5 detected lesions (liver signal intensity enhancement; liver-to-lesion contrast; signal-to-noise ratio; contrast-to-noise Ratio)	Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination	1 year
Secondary	Change(s) in patients' Management based on diagnostic Performance of CMRI or Mangoral-enhanced MRI vs. unenhanced MRI	Assessments will be done during central reading sessions as described for primary outcome. Additionally on-site evaluation will be done within 5 working days after the respective MRI examination	1 year