ALBATROSS Study: International Multicenter Study for Prospective Validation of Imaging Biomarkers Calculated at Vascular Habitats of High-grade Gliomas (ALBATROSS)

February 7, 2022 updated by: Juan M Garcia-Gomez

This Clinical study is framed in the ALBATROSS Project: Clinically validated decision support system based on pixel level Artificial Intelligent models for deciding treatment in glioblastoma.

The prospective multicenter international dataset compiled during the ALBATROSS project will include a cohort up to 300 new patients diagnosed with GB after June 1, 2020. Longitudinal images (T1, T2, T1c, FLAIR, PWI-DSC and DWI at least), complete molecular profiling, primary and secondary lines of treatment and clinical conditions will be included for each patient.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The Hypothesis under study in this project is:

Therapeutic decision making during clinical management of patients with glioblastoma may benefit from delineating functional habitats at pixel level relative to growth, proliferation, infiltration and angiogenesis

The Overall Scientific Objectives of the research proposal are to:

OSO1. Delineate functional habitats from multiparametric MRI relative to the growth, proliferation, infiltration and angiogenesis at the enhanced tumor and infiltrated peripheral edema OSO2. Demonstrate that functional habitats at enhanced tumors and infiltrated peripheral edema show structural, cellular and molecular differences related to the heterogeneity of the tumor region and are compatible with mathematical models of glioma growth and infiltration OSO3. Determine the in-vivo molecular sub-type of patients with glioblastoma from image biomarkers in functional habitats OSO4. Identify groups of patients with glioblastoma presenting positive therapeutic response in terms of longer survival using image biomarkers from functional habitats OSO5. Position ONCOhabitats as a clinical decision support system for the management of patients with glioblastoma

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: María del Mar Álvarez-Torres, mS
  • Phone Number: 669933613
  • Email: maaltor4@upv.es

Study Locations

  • Spain
      • Valencia, Spain, 46021
        • Recruiting
        • Universitat Politècnica de València
        • Contact:
          • María del Mar Álvarez-Torres, mS
          • Phone Number: 669933613
          • Email: maaltor4@upv.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults patients diagnosed with astrocytoma grade IV WHO with histopathological/genetic confirmation who undergo the Stupp treatment

Description

Inclusion Criteria:

  • Patients diagnosed with astrocytoma grade IV WHO with histopathological/genetic confirmation who undergo the Stupp treatment
  • Age > 18 years at diagnosis

  • Patients with access to complete preoperative, postoperative and follow up MRI studies, including:

    • Pre gadolinium T1-weighted MRI
    • Post gadolinium T1-wighted MRI
    • T2-weighted MRI
    • Fluid-Attenuated Inversion Recovery (FLAIR)
    • Dynamic Susceptibility Contrast (DSC) T2*-weighted perfusion sequences
    • Diffusion Weighted Imaging (DWI)
  • Patients who undergo surgery with the possibility to collect samples from different regions of the tumor

Exclusion Criteria:

  • Patient with congestive heart failure within 6 months prior to study entry (New York Heart Association >= Grade 3)

  • Uncontrolled or significant cardiovascular disease, including:

    • Myocardial infarction and transient ischemic attack or stroke within 6 months prior to enrollment
    • Uncontrolled angina within 6 months
    • Diagnosed or suspected congenital long QT syndrome
    • Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
    • Clinically significant abnormality on electrocardiogram (ECG)
  • Pulmonary disease including or greater than grade 2 dyspnea or laryngeal edema, grade 3 pulmonary edema or pulmonary hypertension according to CTCAE 4.03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From date of inclusion (date of first MRI) until the date of death, assessed up to 48 months
Overall Survival is defined as the time from the first presurgical MRI is taken to the patient (MR0) to death
From date of inclusion (date of first MRI) until the date of death, assessed up to 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From date of inclusion (date of first MRI) until the date of documented tumor progression, assessed up to 48 months
Progression Free Survival is defined as the time from the first presurgical MRI is taken to the patient to the detection of tumor relapse
From date of inclusion (date of first MRI) until the date of documented tumor progression, assessed up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juan M Garcia-Gomez

Collaborators

Oslo University Hospital
Hospital Clinic of Barcelona
Hospital de Manises
Azienda Ospedaliero-Universitaria di Parma
Hospital Vall d'Hebron
Centre Hospitalier Universitaire de Liege
Hospital de la Ribera

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALBATROSS Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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