Using FAZA PET/MRI scans to assess treatment response in advanced gastro-oesophageal cancer
Hypoxia Measurement With FAZA PET/MRI in Patients With Metastasized Gastro-Oesophageal Cancer
This study is testing if FAZA PET/MRI scans can help predict how well patients with advanced gastro-oesophageal cancer respond to chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04560036 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of FAZA PET/MRI scans in predicting therapy responses for patients with metastasized gastro-oesophageal cancer undergoing platinum-based chemotherapy. The study aims to identify intratumoral hypoxia, a feature associated with aggressive tumor behavior, which may help in predicting how well patients respond to treatment. By using a single arm design, all participants will receive the FAZA PET/MRI scan before and after their chemotherapy regimen. The goal is to establish a potential biomarker for therapy response in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with de novo or secondary metastasized gastro-oesophageal adenocarcinoma.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new method for predicting treatment responses in patients with advanced gastro-oesophageal cancer, potentially improving patient outcomes.
How similar studies have performed: While the use of imaging techniques in cancer treatment is established, the specific application of FAZA PET/MRI for this purpose is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Patients with de novo or secondary metastasized gastro-oesophagesal cancer (adenocarcinoma) * Glomerular Filtration rate\> 45 ml/min * No allergy to contrast agents Exclusion Criteria: * Contraindication for MR as per current institutional guidelines * Inability to lie supine for at least 30 minutes * Any patient who is pregnant or breastfeeding * Any patient unable or unwilling to provide informed consent * Patients who are allergic to ethanol as the FAZA preparation contains ethanol
Where this trial is running
Toronto, Ontario
- Univeristy Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Patrick Veit-Haibach, MD — University Health Network, Toronto
- Study coordinator: Nirushini Sivasothy
- Email: nirushini.sivasothy@uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.