Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04534543

MAESTRO Study: Metabolic Imaging to Improve Patient-Specific Therapy Outcomes

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2024-08-02

70

Participants Needed

2

Research Sites

267 weeks

Total Duration

On this page

Sponsors

A

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead Sponsor

U

UMC Utrecht

Collaborating Sponsor

AI-Summary

What this Trial Is About

Patients suffering metastasized gastrointestinal cancer often receive ineffective treatments for prolonged periods of time as therapy non-response, which is hard to detect, cannot be determined earlier than nine weeks following start of therapy. Current therapy evaluation strategies primarily focus on morphological changes via RECIST criteria. However, morphological changes are subjected to prior physiological and metabolic alterations. Therefore, the MAESTRO project's ambition is to lay the foundations of a new area of research: the study of human biology using non-invasive chemistry imaging. For this, MAESTRO aims to unite two areas of research: metabolomics and magnetic resonance (MR). Metabolomics studies body functions through the measurements of metabolites; MR imaging (MRI) and spectroscopy (MRS) can provide 3D images of the body and measure metabolite and lipid content respectively. Previous studies show that phospholipid metabolites in particular the cell membrane precursors i.e. phosphomonoesters (PME), and the cell membrane degradation products i.e. phosphodiesters (PDE) are valuable biomarkers in therapy assessment. With this MAESTRO approach, the consortium aims at reducing the nine weeks period before therapy efficacy evaluation to three weeks or less. By validating the powerful new MRS(I)-visible biomarkers in a patient cohort, a non-invasive technology can be developed for dynamically mapping biochemical processes in the whole human body and pave the way for individualized medicine.

CONDITIONS

Official Title

MAESTRO Study: Metabolic Imaging to Improve Patient-Specific Therapy Outcomes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with liver metastasis of gastrointestinal cancer, confirmed by biopsy or CT imaging
  • Tumor size at least 1 cm
  • WHO performance score between 0 and 2
  • Scheduled for first- or second-line palliative chemotherapy with CAPOX or FOLFOX
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Any psychological, family, social, or geographical conditions that may hinder informed consent or study compliance
  • Contraindications for MRI, including pacemaker, cochlear implant, neurostimulator, non-MR compatible metal implants in eye, spine, thorax, abdomen, or brain aneurysm clip
  • Claustrophobia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Amsterdam UMC

Amsterdam, Netherlands

Actively Recruiting

2

UMC Utrecht

Utrecht, Netherlands

Actively Recruiting

Loading map...

Research Team

S

Sebastiaan Siegerink, PhD

CONTACT

H

Hanneke WM van Laarhoven, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here