Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness

NCT ID: NCT01816607

Last Updated: 2018-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Diseases Rectal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rectal cancer

new functional magnetic resonance imaging (MRI) protocols

Intervention Type PROCEDURE

diffusion-weighted MRI, dynamic-contrast enhanced MRI, MR spectroscopy, blood-level oxygen dependent (BOLD) MRI

Interventions

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new functional magnetic resonance imaging (MRI) protocols

diffusion-weighted MRI, dynamic-contrast enhanced MRI, MR spectroscopy, blood-level oxygen dependent (BOLD) MRI

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role lead

Responsible Party

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Kathrine Røe Redalen

Senior scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathrine Røe Redalen, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Locations

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Akershus University Hospital

Lørenskog, Akershus, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 30273860 (View on PubMed)

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.

Reference Type RESULT
PMID: 28001320 (View on PubMed)

Bjornetro 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.

Reference Type DERIVED
PMID: 37438741 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34961902 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33975557 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32870132 (View on PubMed)

Other Identifiers

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REK-2013/152

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

REK-2013/152

Identifier Type: -

Identifier Source: org_study_id

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