Status:
COMPLETED
Predicting RadIotherapy ReSponse of Rectal Cancer With MRI and PET
Lead Sponsor:
Royal North Shore Hospital
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to investigate if PET/CT and MRI scans performed early in treatment and six weeks after treatment can predict the response of rectal cancer following chemotherapy and radi...
Detailed Description
Bowel cancer is the second most prevalent cancer in Australia with rectal cancer the most common subgroup, representing 5% of all cancer diagnoses in 2008 \[1\]. Rectal cancer also accounts for 4.6% o...
Eligibility Criteria
Inclusion
- Age \> 18 years
- T3/4 or node positive rectal cancer
- Suitable for pre-operative chemo-irradiation and surgical resection
- No contraindication to MRI (pacemaker, severe claustrophobia)
- Gross visible disease on MRI
- No contraindications to PET/CT
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky Performance Status \> 70%)
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- \- Previous radiotherapy to pelvis
- Unable/unwilling to have MRI
- Unable/unwilling to have PET/CT
- Pregnancy, lactation or inadequate contraception
- Known allergic reaction to FDG PET contrast
- Pacemaker or implanted defibrillator
- Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study.
- Unwilling or unable to give informed consent
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT02233374
Start Date
September 1 2014
End Date
December 1 2018
Last Update
October 28 2022
Active Locations (1)
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1
Northern Sydney Cancer Centre, Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065