FAZA PET/MRI Pancreas
Parole chiave
Astratto
Descrizione
The success of hypoxia-targeted therapies has so far been limited, a fact widely attributed to the absence of a reliable imaging biomarker for hypoxia that could easily be implemented into a routine clinical workflow. A compelling study has found the presence of hypoxia in pancreatic tumors using FAZA-PET imaging. The data derived from this alternative dual-imaging approach can be used to establish a patient-specific perfusion-to-hypoxia mapping, accounting for differences in tumour metabolisms. This technique was recently validated in a pre-clinical FAZA-PET/CE-MRI study of mice with orthotopically-implanted pancreatic patient-derived tumour xenografts.
The purpose of this study is to look for hypoxia in tumours using a PET scan in combination with MRI. The use of PET/MRI scans to measure hypoxia may be better and simpler than the approaches used previously. This study will assess whether or not PET/MRI scans can provide useful information about hypoxia in pancreatic cancer. Additionally, a recent study at the Princess Margaret Cancer Centre found varying levels of hypoxia in patients with pancreatic tumors, providing a rationale for incorporating hypoxia imaging and patient-specific treatment adaptation into the clinical management of pancreatic cancer.
Date
| Ultimo verificato: | 04/30/2020 |
| Primo inviato: | 05/14/2020 |
| Iscrizione stimata inviata: | 05/14/2020 |
| Primo pubblicato: | 05/19/2020 |
| Ultimo aggiornamento inviato: | 05/14/2020 |
| Ultimo aggiornamento pubblicato: | 05/19/2020 |
| Data di inizio effettiva dello studio: | 07/31/2020 |
| Data di completamento primaria stimata: | 02/28/2023 |
| Data stimata di completamento dello studio: | 02/29/2024 |
Condizione o malattia
Intervento / trattamento
Drug: 18F-FAZA
Fase
Criteri di idoneità
| Età idonea per lo studio | 18 Years Per 18 Years |
| Sessi idonei allo studio | All |
| Accetta volontari sani | sì |
| Criteri | Inclusion Criteria: 1. Participants who have histologically confirmed new diagnosis of unresectable, non-metastatic, LAPAC as assessed by the multidisciplinary tumor board based on pre-RT imaging and clinical assessment, and are amenable to SBRT. 2. Patients who received prior systemic therapy for unresectable LAPAC may be consented and enrolled if they still have localized unresectable LAPAC amenable to SBRT. 3. Participants with newly diagnosed LAPAC who received systemic therapy for borderline resectable pancreatic adenocarcinoma and have become unresectable following preoperative multidisciplinary assessment, are eligible for the study if the patient meets the eligibility criteria based on staging following systemic therapy. 4. Age ≥18 years. 5. ECOG performance status ≤2 (see Appendix A). 6. Life expectancy of greater than 6 months. 7. A negative serum pregnancy test prior to PET-MR imaging, for women of child-bearing age. 8. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients who have had prior RT to upper abdomen. 2. Patients who are receiving any other concomitant investigational agents. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. 3. Patients with early stage resectable (I-II) pancreatic cancer, or known distant metastases. 4. Contraindication to MRI scan as per current institutional guidelines. 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 6. Pregnant women are excluded from this study because of the potential teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants, breastfeeding should be discontinued. 7. Patients who have a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin (other than head and neck region), or carcinoma in situ (e.g., in situ cervical cancer or breast carcinoma) that have undergone potentially curative therapy are not excluded. 8. History or current evidence of any condition, therapy, or laboratory abnormality, known psychiatric or substance abuse disorders that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. |
Risultato
Misure di esito primarie
1. Tumor Hypoxia [2.5 years]
