Clinical trial NCT01816607: Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
Official title: Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Diseases
Rectal Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Keywords: Magnetic Resonance Imaging
Magnetic Resonance Imaging, Functional
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: University of Oslo
First posted: 2013-03-22
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rectal cancer patients referred to radical surgery, with or without preoperative chemoradiotherapy.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Presence of metastatic disease 5 years after rectal cancer treatment
timeFrame: five years
Secondary outcomes:
measure: Histomorphological response to preoperative chemoradiotherapy
timeFrame: 8 weeks
Other outcomes:
measure: Detection of regional malignant lymph nodes at time of diagnosis
timeFrame: 8 weeks
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
state: Akershus
Study officials:
affiliation: University Hospital, Akershus
name: Kathrine Røe Redalen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Grovik 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.
citation: Bousquet 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.
citation: Abrahamsson 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.
citation: Bakke 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.