Clinical trial · Observational
FDG - PET / MRI in Patients With Rectal Cancer
The Value of PET / MRI for the Assessment of Lymph Node Metastasis and Other Prognostic Factors in Patients With Rectal Cancer
- 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 combination of FDG-PET/CT and MRI at staging of rectal cancer in diagnosis is currently very little studied. The investigator have a unique opportunity to study this. Hypothetically, with PET/MR as one hybrid imaging method, alternatively as an additional method, it could increase the accuracy of rectal cancer of moderate and high risk type, especially at primary N-staging, but also in assessing other important prognostic factors such as T-staging, peritoneal involvement, metastasis to lateral lymph nodes, EMVI and MRF involvement. The same reasoning applies to the assessment of tumor regression after CRT. In the study, PET/MR is compared with PET/CT, diagnostic CT and MRI to evaluate the additional value of the hybrid imaging PET/MRI. The investigator also plan to evaluate how immunological, proliferative and prognostic biomarkers in blood and tumor tissue correlate with the radiological findings, and if the combination biomarker and radiology can provide additional prognostic information.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymph Node Metastases | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Improved accuracy with FDG-PET/MR in assessment of local tumor proliferation, lymph node metastasis and other important prognostic factors (MRF +, EMVI) in rectal cancer compared to currently used methods MRI, PET/CT or CT?
- timeFrame
- 8years
- description
- Sensitivity, specificity and likelihood ratios of primary and restaging FDG-PET/MR in the identification of mesorectal lymph node metastases compared to primary and restaging FDG-PET/CT, MRI and CT alone with histopathological examination as reference standard.
- measure
- Improved accuracy in assessment of tumor regression following combined cytostatic and radiation treatment in rectal cancer with FDG-PET/MR compared to MRI or PET/CT?
- timeFrame
- 8years
- description
- Sensitivity, specificity and likelihood ratios of primary and restaging FDG-PET/MR in the characterization of extramural vascular invasion and tumour deposits compared to primary and restaging FDG-PET/CT, MRI and CT alone with histopathological examination as reference standard.
- measure
- Can FDG-PET / MR in combination with blood and tumor tissue biomarkers provide additional prognostic information for intermediate and high-risk rectal cancer?
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \* verified rectal cancer of intermediate or high risk type, scheduled for surgery (non-acute surgery) Exclusion Criteria: * kidney dysfunction * any other contraindications for contrast agents or examination with MRi or FDG-PET/CT
References
Publications (2)
- DERIVEDRutegard MK, Batsman M, Blomqvist L, Rutegard M, Axelsson J, Ljuslinder I, Rutegard J, Palmqvist R, Brannstrom F, Brynolfsson P, Riklund K. Rectal cancer: a methodological approach to matching PET/MRI to histopathology. Cancer Imaging. 2020 Oct 31;20(1):80. doi: 10.1186/s40644-020-00347-6. PMID 33129352
- DERIVEDRutegard MK, Batsman M, Axelsson J, Brynolfsson P, Brannstrom F, Rutegard J, Ljuslinder I, Blomqvist L, Palmqvist R, Rutegard M, Riklund K. PET/MRI and PET/CT hybrid imaging of rectal cancer - description and initial observations from the RECTOPET (REctal Cancer trial on PET/MRI/CT) study. Cancer Imaging. 2019 Jul 23;19(1):52. doi: 10.1186/s40644-019-0237-1. PMID 31337428