Rectal Cancer
Conditions
Brief summary
The purpose of this study is to measure the diagnostic performance of whole body (WB) MR-PET for staging rectal cancer, compared with current standard of care (chest/abdominopelvic CT and rectal MRI) to investigate clinical feasibility of WB MR-PET as a one-stop preoperative imaging modality in patients with rectal cancer.
Interventions
PROCEDUREMR-PET
whole body MR-PET with dedicated liver+rectal protocol
Sponsors
Bayer
Seoul National University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients newly diagnosed with rectal cancer on colonoscopy or sigmoidoscopy, who are potentially eligible for neoadjuvant chemoradiotherapy. 2. Patients who sign informed consent.
Exclusion criteria
1. Patients who are contraindication for CECT 2. Patients who are contraindication for MRI/CE-MRI 3. patients who are diagnosed with Tis or T1 cancer after polypectomy or EMR 4. Patients who were already diagnosed with an active other cancers. 5. Premenopausal female patients who are pregnant. 6. Patients with fasting serum glucose level (\>200mg/dL) on blood glucose meter prior to WB MR-PET. 7. Patients who are physically compromised to undergo WB MR-PET.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the concordance rate between rectal cancer staging performed by WB MR-PET and the current standard of care (chest/abdominopelvic CT and rectal MRI | 12 months | the concordance rate between two protocols (standard protocol vs. WB-MR-PET) would be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| concordance rate of clinical stagings and true M staging obtained by biopsy or follow-up | 18 months | — |
| incidence of recommendation for further workup after examination | 12 months | incidence of recommendation for further w/u after two protocols (standard vs. study) would be compared. |
| concordance rate of clinical staging between standard of care and that obtained by combination of WB MR-PET and chest CT. | 12 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Transient dyspnea | within an hour after MR contrast media administration | incidence of transient dyspnea which can occur after MR contrast agent administration and spontaneously regressed. |
Countries
South Korea
Outcome results
None listed