Clinical trial · Observational
PET/MR for Staging Rectal Cancer Patients With and Without EMVI-MR
The Use of PET/MR for Initial Staging of Rectal Cancer Patients With Extramural Vascular Invasion Detected by MR (EMVI-MR)
NCT02537340CI-TRIAL-00045635completedClinicalTrials.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 hypothesis to be proven with this study is that the use of PET/MR on the initial staging of rectal cancers in patients with extramural vascular invasion detected by MR will detect more lesions than conventional work-up and will significantly impact on therapeutic decision, improving disease free and overall survival.
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 Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- EMVI-MR positive
- description
- Patients with primary rectal cancer and extramural vascular invasion detected by staging MR
- label
- EMVI-MR negative
- description
- Patients with primary rectal cancer and without extramural vascular invasion detected by staging MR
Primary outcomes (1)
- measure
- Detection rate
- timeFrame
- 12 months
- description
- Number of metastatic lesions detected
Secondary outcomes (3)
- measure
- Clinical Impact
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years; * No contraindication to MRI (eletromagnetic devices, claustrophobia); * No contraindication to PET/MR (hyperglycemia, claustrophobia); * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Local resection of rectal tumor; * Non-colorectal synchronic lesion; * Previous treatment (chemo or radiation therapy) for rectal cancer; * Renal insufficiency; * Pregnancy, lactation or inadequate contraception * Known allergy to contrast media (CT, MR or PET); * Blood glucose level higher than 150 mg/dl.
References
Publications (2)
- DERIVEDQueiroz MA, Ortega CD, Ferreira FR, Capareli FC, Nahas SC, Cerri GG, Buchpiguel CA. Value of Primary Rectal Tumor PET/MRI in the Prediction of Synchronic Metastatic Disease. Mol Imaging Biol. 2022 Jun;24(3):453-463. doi: 10.1007/s11307-021-01674-1. Epub 2021 Nov 9. PMID 34755248
- DERIVEDQueiroz MA, Ortega CD, Ferreira FR, Nahas SC, Cerri GG, Buchpiguel CA. Diagnostic accuracy of FDG-PET/MRI versus pelvic MRI and thoracic and abdominal CT for detecting synchronous distant metastases in rectal cancer patients. Eur J Nucl Med Mol Imaging. 2021 Jan;48(1):186-195. doi: 10.1007/s00259-020-04911-x. Epub 2020 Jun 20. PMID 32561971