Clinical trial · Observational
Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
NCT01816607CI-TRIAL-00035857OxyTargetcompletedClinicalTrials.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 establish a reliable method for detection of rectal cancer patients with aggressive tumor at risk of metastatic disease and death by functional MRI.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Diseases | — | UNRESOLVED | — |
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Rectal Diseases | — | UNRESOLVED | — |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| new functional magnetic resonance imaging (MRI) protocols | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Rectal cancer
- interventionNames
- Procedure: new functional magnetic resonance imaging (MRI) protocols
Primary outcomes (1)
- measure
- Presence of metastatic disease 5 years after rectal cancer treatment
- timeFrame
- five years
Secondary outcomes (1)
- measure
- Histomorphological response to preoperative chemoradiotherapy
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The patient is willing and able to give full written consent according to the protocol approved by the Regional Ethics Committee. * The patient has confirmed rectal cancer diagnosis and is scheduled to radical surgery alone or preoperative CRT followed by surgery. * The patient is ≥ 18 years. * The patient has no prior rectal cancer treatment. * The patient has adequate renal function: creatinine clearance ≥ 60 ml/minute. * The patient has signed the written informed consent according to the protocol approved by the Regional Ethics Committee. Exclusion Criteria: * The patient has contraindication to MRI or MRI contrast agent according to clinical practice. * The patient wants to withdraw for any reason during the study.
References
Publications (7)
- RESULTBousquet PA, Meltzer S, Sonstevold L, Esbensen Y, Dueland S, Flatmark K, Sitter B, Bathen TF, Seierstad T, Redalen KR, Eide L, Ree AH. Markers of Mitochondrial Metabolism in Tumor Hypoxia, Systemic Inflammation, and Adverse Outcome of Rectal Cancer. Transl Oncol. 2019 Jan;12(1):76-83. doi: 10.1016/j.tranon.2018.09.010. Epub 2018 Sep 29. PMID 30273860
- RESULTGrovik E, Redalen KR, Storas TH, Negard A, Holmedal SH, Ree AH, Meltzer S, Bjornerud A, Gjesdal KI. Dynamic multi-echo DCE- and DSC-MRI in rectal cancer: Low primary tumor Ktrans and DeltaR2* peak are significantly associated with lymph node metastasis. J Magn Reson Imaging. 2017 Jul;46(1):194-206. doi: 10.1002/jmri.25566. Epub 2016 Dec 21. PMID 28001320
- DERIVEDBakke KM, Bjornetro T, Bousquet PA, Sanabria AM, Meltzer S, Luders T, Troseid AS, Stang E, Negard A, Froyen EA, Lunder AK, Lyckander LG, Aass HCD, Redalen KR, Ree AH. Dissemination of Mitochondrial DNA Variants: Looking at the 'Bigger' Picture of the Tumour Microenvironment in Rectal Cancer Patients. J Extracell Biol. 2025 Oct 30;4(11):e70097. doi: 10.1002/jex2.70097. eCollection 2025 Nov. PMID 41179924
- DERIVEDBjornetro T, Bousquet PA, Redalen KR, Troseid AS, Luders T, Stang E, Sanabria AM, Johansen C, Fuglestad AJ, Kersten C, Meltzer S, Ree AH. Next-generation sequencing reveals mitogenome diversity in plasma extracellular vesicles from colorectal cancer patients. BMC Cancer. 2023 Jul 12;23(1):650. doi: 10.1186/s12885-023-11092-x. PMID 37438741
- DERIVEDBousquet PA, Meltzer S, Fuglestad AJ, Luders T, Esbensen Y, Juul HV, Johansen C, Lyckander LG, Bjornetro T, Inderberg EM, Kersten C, Redalen KR, Ree AH. The mitochondrial DNA constitution shaping T-cell immunity in patients with rectal cancer at high risk of metastatic progression. Clin Transl Oncol. 2022 Jun;24(6):1157-1167. doi: 10.1007/s12094-021-02756-w. Epub 2021 Dec 27. PMID 34961902
- DERIVEDAbrahamsson H, Meltzer S, Hagen VN, Johansen C, Bousquet PA, Redalen KR, Ree AH. Sex disparities in vitamin D status and the impact on systemic inflammation and survival in rectal cancer. BMC Cancer. 2021 May 11;21(1):535. doi: 10.1186/s12885-021-08260-2.