None listed
Conditions
Brief summary
The main purpose of this study is to assess whether MRI (including MRI with contrast) and PET can predict response to treatment in patients with locally advanced rectal cancer. 'Who is it for?' You may be eligible to join this study if you have been diagnosed with rectal cancer and are undergoing treatment consisting of chemoradiotherapy followed by surgery. 'Study details' Participants will have standard treatment, consisting of neoadjuvant chemoradiotherapy followed by surgery. There will be no change to treatment by participating in this study. Patients participating in this study will have multi-parametric MRI (diffusion weighted imaging (DWI) and dynamic contrast enhanced (DCE)) and PET/CT at the following 3 time-points: 1. Prior to chemoradiotherapy 2. During the third week of chemoradiotherapy and 3. Post chemoradiotherapy, within 1 week prior to surgery. Patients will be followed up for 2 years. Correlations between MRI and PET biomarkers with tumour response and survival outcomes will determine whether multi-parametric MRI and PET can predict treatment response.
Interventions
Single arm prospective observationaI imaging biomarker study.
Patients will have standard treatment, consisting of neoadjuvant chemoradiotherapy followed by surgery. There will be no change to the patient's treatment by participating in this study. Patients participating in this study will have multi-parametric MRI and PET/CT at the following 3 time-points:
1. Prior to chemoradiotherapy
2. During the third week of chemoradiotherapy
3. Post chemoradiotherapy, within 1 week prior to surgery.
Single arm prospective observationaI imaging biomarker study. Patients will have standard treatment, consisting of neoadjuvant chemoradiotherapy followed by surgery. There will be no change to the patient's treatment by participating in this study. Patients participating in this study will have multi-parametric MRI and PET/CT at the following 3 time-points: 1. Prior to chemoradiotherapy 2. During the third week of chemoradiotherapy 3. Post chemoradiotherapy, within 1 week prior to surgery. A multi-parametric MRI incorporates standard morphological as well as diffusion weighted imaging and dynamic contrast enhanced sequences. The total follow-up duration will be 2 years from date of surgery.
Sponsors
Dr Trang Pham
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than 18 2. Stage II or III rectal adenocarcinoma, defined as T3 - T4 and/or node positive disease (N1-2), without distant metastatic disease (M0) 3. No evidence of metastatic disease on CT chest/abdomen/pelvis 4. Undergoing treatment algorithm consisting of neoadjuvant chemoradiotherapy (radiotherapy 50.4Gy in 28 fractions concurrent with infusional 5-fluorouracil or oral capecitabine) followed by surgery at 6 to 12 weeks post chemoradiotherapy.
Exclusion criteria
1. Other malignancy 2. Active inflammatory bowel disease 3. On concurrent high-dose corticosteroids (the equivalent of 50mg prednisone daily) 4. Inability to have MRI due to: a. Implanted magnetic metal eg. Intraocular metal b. Pacemaker / Implantable defibrillator c. Extreme claustrophobia.
Outcome results
None listed