臨床研究等提出・公開システム

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)

A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems)
(Quanti OBR)

Myoishi Masafumi

Bayer Yakuhin, Ltd.

2-4-9 Umeda, Kita-ku, Osaka, Osaka

byl_ct_contact@bayer.com

Dedicated contact

Bayer Yakuhin, Ltd.

2-4-9 Umeda, Kita-ku, Osaka, Osaka

+81-6-6133-6363

byl_ct_contact@bayer.com

Complete

Aug. 21, 2023

Interventional

randomized controlled trial

double blind

active control

crossover assignment

diagnostic purpose

- Participants with a clinical indication for a contrast-enhanced MRI (including magnetic resonance angiography [MRA]), 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 central nervous system [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).

- Participants who can undergo study-related procedures, including 2 contrast-enhanced MRI examinations (one with gadoquatrane and one with a comparator macrocyclic GBCA), as per participant and Investigators judgement

- Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

- Considered clinically unstable or has a concurrent/concomitant condition that may significantly alter image comparability between the 2 study MRIs or between study parameters (e.g. safety, pharmacokinetics [PK] parameters) or would not allow participation for the full planned study period, in the judgement of the investigator

- Participants presenting with severe renal insufficiency, defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, derived from a serum or plasma creatinine sample obtained within 48 hours prior to the first contrast agent injection in the study

- Participants with acute kidney injury (i.e., acute renal failure), regardless of eGFR

- History of moderate to severe allergic-like reaction to any GBCA

- Bronchial asthma considered unstable or who have had recent modification to their medical therapy.

- Receipt of any contrast agent < 72 h prior to the study MRIs or planned to receive any contrast agent during the trial until 24 h +/- 4 h after the second study MRI

- Planned or expected interventional diagnostic or therapeutic procedure (e.g. biopsy or surgery in the region of interest) or change in treatment (e.g. start of chemotherapy or antiangiogenic therapy, significant change in corticosteroids dose) that may significantly alter image comparability between the 2 MRIs or other study parameters (i.e. safety/adverse events [AEs] [e.g. confounding AEs or safety events due to surgery or chemotherapy], PK parameters), from the first study MRI up to 24 h after the second study MRI

- Has received any investigational product within 30 days, or within 5 times half-life of the investigational product, whatever is shorter, prior to or concurrent with this study

- Contraindications to the administration of macrocyclic GBCAs (depending on local product label), or history of adverse reaction to gadoquatrane

- Any contraindication to MRI examinations based on institution policy and investigators clinical judgement (e.g. some metallic implants or active implants)

Both

Adults with known or suspected pathology of any body region (except CNS)

- Drug: Gadoquatrane (BAY1747846)
0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose

- Drug: Gadobutrol
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose

- Drug: Gadoterate meglumine
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose

- Drug: Gadoteridol
Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose

- Visualization parameter contrast Enhancement assessed by separate blinded evaluation of combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR

- Visualization parameter delineation assessed by separate blinded evaluation of combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR

- Visualization parameter morphology assessed by separate blinded evaluation of combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR

+81-11-716-1161

June. 09, 2023

No

Argentina/Bulgaria/Canada/China/Czechia/France/Germany/Hungary/Italy/Korea, Republic of/Poland/Sweden/Taiwan/Turkey/United Kingdom/United States