Clinical Trials List
2023-09-29 - 2025-01-16
Phase III
Not yet recruiting2
Recruiting1
Terminated1
ICD-10Z01.89
Encounter for other specified special examinations
ICD-9V72.5
Radiological examination, not elsewhere classified
A multicenter, randomized, prospective double-blind, cross-over Phase 3 study to evaluate the efficacy and safety of 0.04 mmol Gd/kg body weight of gadoquatrane for MRI in adults with known or suspected pathology of any body region (except CNS), compared to 0.1 mmol Gd/kg approved macrocyclic gadolinium-based contrast agents (GBCAs)
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Trial Applicant
BAYER TAIWAN COMPANY LTD.
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Sponsor
Bayer AG
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Trial scale
Multi-Regional Multi-Center
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Update
2025/11/03
Investigators and Locations
Co-Principal Investigator
- MING-CHE LIU Division of Urology
- Li-Chun Hsieh Division of Radiology
- 倪承賦 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ming-Yao Chen Digestive System Department
- 丁偉義 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Dotarem (Gadoteric acid)
Active Ingredient
Gadoteric acid
Dosage Form
270
Dosage
279.32 mg (equivalent to 0.5 mmol/ml)
Endpoints
(enhancement on a 4PS,
delineation on a 4PS, morphology on a 3PS) assessed by
separate blinded evaluation of combined pre- and postgadoquatrane MRI and combined pre- and post-comparator
MRI with macrocyclic GBCAs
1
, by a BICR
Inclution Criteria
with any approved standard of care macrocyclic GBCA with proven efficacy, safety
and tolerability in clinical routine CE-MRI/MRA (gadobutrol, gadoterate meglumine/
gadoteric acid or gadoteridol) that is used at the site for the indication, with known or
suspected pathology of any body region, e.g. head and neck (except CNS), thorax
(including e.g. breast, heart, chest wall), abdomen (including e.g. liver, kidney,
pancreas), pelvis (including e.g. prostate, uterus, ovaries), extremities (including upper
and lower.
Note: pathology includes any vasculature or non-vasculature abnormality, such as
benign or malignant (primary/secondary) tumoral lesions; inflammatory or infectious
lesions; vascular abnormalities, such as stenotic or aneurysmal lesions; malformative
lesions; and any other lesion of body, and associated vessels that are commonly
evaluated with CE-MRI.
The study will be monitored by GCIS for the actual prevalence of contrast-enhancing
lesions in the images sets to ensure sufficient numbers for the evaluation of endpoints.
If the prevalence is below 65%, investigators will be instructed to enroll subjects with
confirmed lesions. Additionally, the study will be monitored for enrollment per body
region and certain target organs (see Section 4.1). Investigators will be instructed to
enroll subjects with CE MRI examinations of certain body regions, target organs
including blood vessels if representative number of certain CE MRIs cannot be
included.
Exclusion Criteria
significantly alter image comparability between the 2 study MRIs or between study
parameters (e.g. safety, PK parameters) or would not allow participation for the full
planned study period, in the judgement of the investigator.
2. Participants presenting with severe renal insufficiency, defined as an estimated
glomerular filtration rate (eGFR) < 30 mL/min/1.73 m², derived from a serum
creatinine sample obtained within 48 hours prior to the first contrast agent injection in
the study. See Section 8.1.3.
3. Participants with acute kidney injury (i.e., acute renal failure), regardless of eGFR
4. History of moderate to severe allergic-like reaction to any GBCA
5. Bronchial asthma considered unstable and/or requiring medical treatment
The Estimated Number of Participants
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Taiwan
30 participants
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Global
500 participants
