News | Contrast Media | March 24, 2021

Gadopiclenol has Positive Results for Phase III Clinical Trials 

Gadopiclenol is a high-relaxivity macrocyclic contrast agent used for magnetic resonance imaging (MRI)

Gadopiclenol is a high-relaxivity macrocyclic contrast agent used for magnetic resonance imaging (MRI)

March 24, 2021 — Guerbet announced positive results from two Phase III clinical studies comparing the diagnostic efficacy and safety of Gadopiclenol to Gadobutrol in a wide range of indications, covering the central nervous system and various other anatomical areas (head and neck, thorax, abdomen, pelvis, musculoskeletal system).

A total of 560 patients were recruited for these two studies in over 60 hospital medical imaging departments in 13 countries.

The endpoints were met in terms of the diagnostic benefit of injecting Gadopiclenol (0.05 mmol/kg) during MRI examinations, based on: 1/ the superiority of the examination with Gadopiclenol compared to the examination with no contrast agent; and 2/ the non-inferiority of Gadopiclenol (0.05 mmol/kg) compared to Gadobutrol (0.1 mmol/kg) for the visualization and detection of lesions of the central nervous system and in the other anatomical areas studied.

In addition to these Phase III trials, a study was conducted on 80 children between 2 and 17 years of age in 19 centers in five European countries. This study showed that the pharmacokinetic profile of Gadopiclenol at 0.05 mmol/kg in children was similar to that of adults. It will therefore be possible to extrapolate the efficacy of Gadopiclenol to the pediatric population based on data collected in adult patients.

No major safety signals were reported during the development of Gadopiclenol, and the adverse reactions reported during the two Phase III studies were similar for both of the products administered.

"We are very happy with the results of these studies, which demonstrate the diagnostic value and good tolerance of Gadopiclenol during an MRI examination in adults and children. By using a lower dose of gadolinium in clinical practice, we hope this macrocyclic contrast agent will become a 'best-in-class' diagnostic solution for doctors and their patients." said David Hale, CEO of Guerbet. 

All this data will serve as a basis for regulatory submissions, which will begin in the United States and in the European Union (EU) early 2022.

For more information: www.guerbet.com

 

Related Content

CDC and FDA Call for Pause on Janssen COVID-19 Vaccine Due to Rare Blood Clots #COVID19 #Janssen
Feature | Coronavirus (COVID-19) | April 15, 2021 | By Dave Fornell
April 15, 2021 — The U.S.
#SiemensHealthineers #Varian #Siemens The transformative combination accelerates the company’s impact on #global #healthcare and establishes a strong partner for #customers and #patients along the entire #cancer care continuum and for many of the most threatening #diseases
News | Radiology Business | April 15, 2021
April 15, 2021 — Siemens Healthineers AG an
Comparisons of high definition and standard definition infrared imaging for digital histopathology. Image courtesy of the Beckman Institute

Comparisons of high definition and standard definition infrared imaging for digital histopathology. Image courtesy of the Beckman Institute

News | Breast Imaging | April 14, 2021
April 14, 2021 — Detecting and analyzing breast cancer
A doctor reading #CXR scans using #SenseCare-Chest #DR Pro #diagnostic #software.

A doctor reading CXR scans using SenseCare-Chest DR Pro diagnostic software.

News | Artificial Intelligence | April 14, 2021
April 14, 2021 — SenseTime, a world-leading...
A 37-year-old woman developed a new, palpable left supraclavicular lymphadenopathy lump five days after her first dose of the Moderna COVID-19 vaccine in the left arm. On the day of vaccination, the patient was asymptomatic. This is an example of how the vaccine can mimic cancer and swollen lymph nodes. Image used with permission of RSNA.

A 37-year-old woman developed a new, palpable left supraclavicular lymphadenopathy lump five days after her first dose of the Moderna COVID-19 vaccine in the left arm. On the day of vaccination, the patient was asymptomatic. This is an example of how the vaccine can mimic cancer and swollen lymph nodes. Read more about this case study. Image used with permission of RSNA.

Feature | Coronavirus (COVID-19) | April 09, 2021 | By Dave Fornell, Editor
While the mass COVID-19 vaccinat
3-D mammography reduces the number of breast cancer cases diagnosed in the period between routine screenings, when compared with traditional mammography, according to a large study from Lund University in Sweden. The results are published in the journal Radiology.

Getty Images

News | Breast Imaging | April 09, 2021
April 9, 2021 — 3-D mammography reduces the number of breast cancer cases diagnosed in the period between routine scr
IV contrast-enhanced 2-mSv 4-mm-thick transverse and coronal (b) CT images show inflamed diverticula (arrows), segmental colonic wall thickening, and adjacent pericolic fat stranding. Image courtesy of the American Roentgen Ray Society (ARRS), American Journal of Roentgenology (AJR)

IV contrast-enhanced 2-mSv 4-mm-thick transverse and coronal (b) CT images show inflamed diverticula (arrows), segmental colonic wall thickening, and adjacent pericolic fat stranding. Image courtesy of the American Roentgen Ray Society (ARRS), American Journal of Roentgenology (AJR)

News | Computed Tomography (CT) | April 09, 2021
April 9, 2021 — According to an open-acc...
Futuristic campus design of Siemens Healthineers in Bengaluru, India.

Futuristic campus design of Siemens Healthineers in Bengaluru, India.

News | Radiology Business | April 08, 2021
April 8, 2021 — Siemens Healthineers announced t