About this trial
feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient over 18 years old.
Diagnosis of histologically confirmed rectal adenocarcinoma for which nRCT has been indicated.
Karnofsky Index (KPS) ≥ 70 or ECOG = 0 or 1
Signed consent to participation.
Disqualifiers
Predominant mucinous component on initial MRI, biopsy and / or definitive pathology. Mucin may lead to overestimation of ADC values on DWIs.
Contraindications to the MRI procedure (non compatible pacemaker or other metallic foreign body, severe claustrophobia).
Exclusive radiation therapy.
Other associated neo-adjuvant treatment.
Trial population
The study population consists of men and / or women over 18 years of age, with no upper limit age, with histologically confirmed non-metastatic rectal adenocarcinoma and for whom treatment with nRCT has been indicated.
Trial design
Cohort
Prospective
Treatments tested in this trial
MRI-guided radiotherapy by on-board DWI sequences
DeviceThe radiotherapy treatment will be delivered on the MRI-guided radiotherapy platform. The on-board DWI sequences will be performed every three fractions in addition to the treatment session and will last approximately 3-4 minutes.
Treatment groups
Trial outcomes
Primary outcomes
Predictive value of Apparent Diffusion Coefficient measured using MRgRT system
Pathological complete response using AJCC criteria
Sponsors and contacts
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Institut Paoli-Calmettes
Lead sponsor
University of California, Los Angeles
Collaborator