Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
OxyTarget
1 other identifier
observational
192
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2013
CompletedFirst Posted
Study publicly available on registry
March 22, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedNovember 19, 2018
November 1, 2018
4.2 years
March 20, 2013
November 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence of metastatic disease 5 years after rectal cancer treatment
five years
Secondary Outcomes (1)
Histomorphological response to preoperative chemoradiotherapy
8 weeks
Other Outcomes (1)
Detection of regional malignant lymph nodes at time of diagnosis
8 weeks
Study Arms (1)
Rectal cancer
Interventions
diffusion-weighted MRI, dynamic-contrast enhanced MRI, MR spectroscopy, blood-level oxygen dependent (BOLD) MRI
Eligibility Criteria
Rectal cancer patients referred to radical surgery, with or without preoperative chemoradiotherapy.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Akershuslead
- Oslo University Hospitalcollaborator
- University of Oslocollaborator
Study Sites (1)
Akershus University Hospital
Lørenskog, Akershus, 1478, Norway
Related Publications (7)
Bousquet 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: 30273860RESULTGrovik 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: 28001320RESULTBakke 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: 41179924DERIVEDBjornetro 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: 37438741DERIVEDBousquet 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: 34961902DERIVEDAbrahamsson 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.
PMID: 33975557DERIVEDBakke KM, Meltzer S, Grovik E, Negard A, Holmedal SH, Gjesdal KI, Bjornerud A, Ree AH, Redalen KR. Sex Differences and Tumor Blood Flow from Dynamic Susceptibility Contrast MRI Are Associated with Treatment Response after Chemoradiation and Long-term Survival in Rectal Cancer. Radiology. 2020 Nov;297(2):352-360. doi: 10.1148/radiol.2020200287. Epub 2020 Sep 1.
PMID: 32870132DERIVED
Biospecimen
Blood, rectal cancer tissue, normal tissue, lymph nodes
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathrine Røe Redalen, PhD
University Hospital, Akershus
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior scientist
Study Record Dates
First Submitted
March 20, 2013
First Posted
March 22, 2013
Study Start
October 1, 2013
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
November 19, 2018
Record last verified: 2018-11