Improving treatment outcomes for metastatic gastrointestinal cancer using metabolic imaging
Official title: MAESTRO Study: Metabolic Imaging to Improve Patient-Specific Therapy Outcomes
Run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT04534543 · Data updated 2026-11-12
This study is testing if special MRI and spectroscopy techniques can help doctors see how well treatment is working for patients with metastatic gastrointestinal cancer after two weeks of therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Amsterdam and 1 other locations) |
| Status | Recruiting |
| Started | December 15, 2021 |
| Main results expected | February 1, 2027 |
| Study ends | February 1, 2027 |
| Registry record updated | August 2, 2024 |
| Trial ID | NCT04534543 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with liver metastasis from gastrointestinal cancer who are scheduled for first- or second-line palliative chemotherapy.
✕Probably not a fit
Patients with contraindications for MR scanning or those unable to provide informed consent due to psychological or sociological conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the use of non-invasive metabolic imaging techniques, specifically magnetic resonance imaging (MRI) and spectroscopy (MRS), to evaluate treatment response in patients with metastatic gastrointestinal cancer. By measuring changes in metabolic phospholipid ratios after two weeks of therapy, the study aims to predict progression-free survival and overall survival outcomes. The research combines metabolomics and MR imaging to provide a more accurate assessment of treatment efficacy compared to traditional methods that focus solely on morphological changes. The study population includes patients scheduled for specific chemotherapy regimens, and it seeks to establish a predictive model for treatment resistance.
Why it matters
Potential benefit: If successful, this approach could lead to earlier identification of ineffective treatments, allowing for timely adjustments to therapy and improved patient outcomes.
How similar studies have gone: Previous studies have shown promise in using metabolic imaging for treatment evaluation, suggesting that this approach may yield beneficial results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with liver metastasis of gastrointestinal cancer, with histological or cytological proof of metastasis or a high suspicion on CT imaging. * Tumour size ≥ 1cm. * WHO-performance score 0-2. * Scheduled for first- or second-line palliative chemotherapy containing capecitabine combined with oxaliplatin (CAPOX) or fluorouracil combined with oxaliplatin and folinic acid (FOLFOX). * Written informed consent. Exclusion Criteria: * Any psychological, familial, sociological, or geographical condition potentially hampering adequate informed consent or compliance with the study protocol. * Contra-indications for MR scanning, including patients with a pacemaker, cochlear implant or neurostimulator; patients with non-MR compatible metallic implants in their eye, spine, thorax or abdomen; or a non-MR compatible aneurysm clip in their brain; patients with claustrophobia.
Where it's running
-
Amsterdam UMC
Amsterdam, Netherlands Recruiting -
UMC Utrecht
Utrecht, Netherlands Recruiting
Study contacts
- Principal investigator: Hanneke WM van Laarhoven, MD PhD — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study coordinator: Sebastiaan Siegerink, PhD
- Email: s.n.siegerink@amsterdamumc.nl
- Phone: 0623674312
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.