search
Back to results

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

Primary Purpose

Known or Suspected Focal Liver Lesions and Severe Renal Impairment

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mangoral
Sponsored by
Ascelia Pharma AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Known or Suspected Focal Liver Lesions and Severe Renal Impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic - Arizona
  • University of California at Los Angeles Ronald Reagan Medical Center
  • Stanford University School of Medicine
  • Mayo Clinic - Jacksonville
  • Schiff Center for Liver Diseases
  • University of Kansas Medical Center
  • Johns Hopkins Bayview Medical Center
  • Massachusetts General Hospital
  • Boston University Medical Center
  • Saint Louis University
  • Duke University
  • PanAmerican Clinical Research LLC
  • University of Washington Medical Center
  • University of Wisconsin - Madison
  • Fundación Intecnus
  • Centro Rossi Body Imaging
  • Sanatorio Allende Nueva Córdoba
  • Hospital Pablo Tobon Uribe
  • Clínica Universitaria Colombia
  • Sociedad de Cirugía de Bogotá - Hospital de San José
  • Charité - Universitätsmedizin Berlin
  • Universitätsklinikum Frankfurt Institut für Diagnostische und Interventionelle Radiologie
  • Universitätsmedizin Göttingen
  • Städtisches Klinikum KarlsruheDiagnostische und interventionelle Radiologie
  • Universitättsklinikum Schleswig-Holstein/Campus KielKlinik für Radiologie und Neuroradiologie
  • Klinik und Poliklinik für Radiologie Klinikum der Universität München LMU Campus
  • Institut für Röntgendiagnostik
  • Azienda Socio Sanitaria Territoriale (ASST)
  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola-Malpighi
  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  • Ospedale del Mare
  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
  • Università Cattolica del Sacro Cuore
  • Azienda Ospedaliero-Universitaria Policlinico Umberto I
  • Ospedale di Belcolle
  • Panamerican Clinical Research - Cuernavaca Rio Mayo
  • Panamerican Clinical Research Mexico
  • Panamerican Clinical Research - Querétaro Avenida Paseo de la República
  • Szpital Uniwersytecki nr 1 im. Dr A. Jurasza, Wydział Katedra i Zakład Radiologii i Diagnostyki Obrazowej
  • Szpital Uniwersytecki w Krakowie Zakład Diagnostyki Obrazowej CUMRiK Ul
  • EuroMedis Sp. z o.o.
  • Altay Regional Oncology Dispencery
  • State Institution of Healthcare "Regional Oncology Dispensary"
  • Scientific and Research Institute of Oncology named after N.N. Blokhin
  • A.V. Vishnevsky Institute of Surgery
  • National Medical Research Radiology Center Named After Herzen
  • JSC "Avicenna"
  • State Institution of Healthcare of Omsk region
  • SBIH of Pskov Regional Clinical Oncologic Dispensary
  • LLC "Clinica YZI 4D"
  • N.N. Petrov Research Institute of Oncology
  • Saint-Petersburg State Budgetary Healthcare Institution
  • Smolensk Clinical Hospital
  • State Autonomous Healthcare Institution of the Tyumen Region
  • Karolinska University Hospital Huddinge
  • Ege University Medical Faculty Hospital
  • Erciyes University Medical Faculty Hospital
  • Kocaeli University
  • Hacettepe University Medical Faculty Hospital
  • İstanbul Üniversitesi - Istanbul Tıp Fakültesi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mangoral

Arm Description

All participants will receive a single dose of Mangoral (equivalent to 800 mg Manganese (II) chloride tetrahydrate [MnCl2 4H2O]).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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
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
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
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

Full Information

First Posted
September 29, 2019
Last Updated
August 14, 2023
Sponsor
Ascelia Pharma AB
search

1. Study Identification

Unique Protocol Identification Number
NCT04119843
Brief Title
Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 19, 2020 (Actual)
Primary Completion Date
February 27, 2023 (Actual)
Study Completion Date
February 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascelia Pharma AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Known or Suspected Focal Liver Lesions and Severe Renal Impairment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Multicenter, open-label, pivotal phase III study
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mangoral
Arm Type
Experimental
Arm Description
All participants will receive a single dose of Mangoral (equivalent to 800 mg Manganese (II) chloride tetrahydrate [MnCl2 4H2O]).
Intervention Type
Drug
Intervention Name(s)
Mangoral
Intervention Description
800 mg manganese chloride [II] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of lesions detected by each MRI method (unenhanced MRI, Mangoral-enhanced MRI, and CMRI.)
Description
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
Time Frame
1 year
Title
Visualization of focal liver lesions in Mangoral-enhanced MRI as compared to unenhanced MRI
Description
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
Time Frame
1 year
Title
Confidence in lesion detection separately in unenhanced MRI, Mangoral-enhanced MRI, and CMRI
Description
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
Time Frame
1 year
Title
Confidence in lesion localization separately in unenhanced MRI, Mangoral-enhanced MRI, and CMRI
Description
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
Time Frame
1 year
Title
Lesion dimensions: longest diameter of largest and smallest lesion
Description
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
Time Frame
1 year
Title
Quantitative assessments for up to 5 detected lesions (liver signal intensity enhancement; liver-to-lesion contrast; signal-to-noise ratio; contrast-to-noise Ratio)
Description
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
Time Frame
1 year
Title
Change(s) in patients' Management based on diagnostic Performance of CMRI or Mangoral-enhanced MRI vs. unenhanced MRI
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd Hamm, MD
Organizational Affiliation
Charite Berlin, Dept. of Radiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic - Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of California at Los Angeles Ronald Reagan Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Schiff Center for Liver Diseases
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63103
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
PanAmerican Clinical Research LLC
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78521
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Fundación Intecnus
City
San Carlos De Bariloche
State/Province
Río Negro
ZIP/Postal Code
R8405AZA
Country
Argentina
Facility Name
Centro Rossi Body Imaging
City
Buenos Aires
ZIP/Postal Code
C1425 BEE
Country
Argentina
Facility Name
Sanatorio Allende Nueva Córdoba
City
Cordoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Facility Name
Hospital Pablo Tobon Uribe
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
69-240
Country
Colombia
Facility Name
Clínica Universitaria Colombia
City
Bogotá
State/Province
Cundinamarca
ZIP/Postal Code
111221
Country
Colombia
Facility Name
Sociedad de Cirugía de Bogotá - Hospital de San José
City
Bogotá
State/Province
Cundinamarca
ZIP/Postal Code
111611
Country
Colombia
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Universitätsklinikum Frankfurt Institut für Diagnostische und Interventionelle Radiologie
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
Country
Germany
Facility Name
Städtisches Klinikum KarlsruheDiagnostische und interventionelle Radiologie
City
Karlsruhe
ZIP/Postal Code
76227
Country
Germany
Facility Name
Universitättsklinikum Schleswig-Holstein/Campus KielKlinik für Radiologie und Neuroradiologie
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinik und Poliklinik für Radiologie Klinikum der Universität München LMU Campus
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Institut für Röntgendiagnostik
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Azienda Socio Sanitaria Territoriale (ASST)
City
Milano
State/Province
Lombardy
ZIP/Postal Code
20157
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Bologna Policlinico S.Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Ospedale del Mare
City
Napoli
ZIP/Postal Code
80147
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
City
Napoli
Country
Italy
Facility Name
Università Cattolica del Sacro Cuore
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Ospedale di Belcolle
City
Viterbo
ZIP/Postal Code
01100
Country
Italy
Facility Name
Panamerican Clinical Research - Cuernavaca Rio Mayo
City
Cuernavaca
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Panamerican Clinical Research Mexico
City
Guadalajara
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Panamerican Clinical Research - Querétaro Avenida Paseo de la República
City
Querétaro
ZIP/Postal Code
76230
Country
Mexico
Facility Name
Szpital Uniwersytecki nr 1 im. Dr A. Jurasza, Wydział Katedra i Zakład Radiologii i Diagnostyki Obrazowej
City
Bydgoszcz
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie Zakład Diagnostyki Obrazowej CUMRiK Ul
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
EuroMedis Sp. z o.o.
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Altay Regional Oncology Dispencery
City
Barnaul
ZIP/Postal Code
Zmeigorsky trakt 110
Country
Russian Federation
Facility Name
State Institution of Healthcare "Regional Oncology Dispensary"
City
Irkutsk
ZIP/Postal Code
664035
Country
Russian Federation
Facility Name
Scientific and Research Institute of Oncology named after N.N. Blokhin
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
A.V. Vishnevsky Institute of Surgery
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
National Medical Research Radiology Center Named After Herzen
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
JSC "Avicenna"
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
State Institution of Healthcare of Omsk region
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
SBIH of Pskov Regional Clinical Oncologic Dispensary
City
Pskov
ZIP/Postal Code
180004
Country
Russian Federation
Facility Name
LLC "Clinica YZI 4D"
City
Pyatigorsk
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
N.N. Petrov Research Institute of Oncology
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Saint-Petersburg State Budgetary Healthcare Institution
City
Saint Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Smolensk Clinical Hospital
City
Smolensk
ZIP/Postal Code
214006
Country
Russian Federation
Facility Name
State Autonomous Healthcare Institution of the Tyumen Region
City
Tyumen
ZIP/Postal Code
625033
Country
Russian Federation
Facility Name
Karolinska University Hospital Huddinge
City
Stockholm
Country
Sweden
Facility Name
Ege University Medical Faculty Hospital
City
Bornova
State/Province
İzmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Erciyes University Medical Faculty Hospital
City
Melikgazi
State/Province
Kayseri
ZIP/Postal Code
38030
Country
Turkey
Facility Name
Kocaeli University
City
İzmit
State/Province
Kocaeli
ZIP/Postal Code
41001
Country
Turkey
Facility Name
Hacettepe University Medical Faculty Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
İstanbul Üniversitesi - Istanbul Tıp Fakültesi
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs