Clinical trial · Observational
Rectal Cancer Staging Using Whole Body MR-PET
Preoperative Imaging for Rectal Cancer Staging Using Whole Body MR-PET
NCT02651701CI-TRIAL-00042185completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR-PET | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- the concordance rate between rectal cancer staging performed by WB MR-PET and the current standard of care (chest/abdominopelvic CT and rectal MRI
- timeFrame
- 12 months
- description
- the concordance rate between two protocols (standard protocol vs. WB-MR-PET) would be calculated.
Secondary outcomes (3)
- measure
- incidence of recommendation for further workup after examination
- timeFrame
- 12 months
- description
- incidence of recommendation for further w/u after two protocols (standard vs. study) would be compared.
- measure
- concordance rate of clinical staging between standard of care and that obtained by combination of WB MR-PET and chest CT.
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDYoon JH, Lee JM, Chang W, Kang HJ, Bandos A, Lim HJ, Kang SY, Kang KW, Ryoo SB, Jeong SY, Park KJ. Initial M Staging of Rectal Cancer: FDG PET/MRI with a Hepatocyte-specific Contrast Agent versus Contrast-enhanced CT. Radiology. 2020 Feb;294(2):310-319. doi: 10.1148/radiol.2019190794. Epub 2019 Dec 3. PMID 31793850