Rectal DiseasesOxyTargetNCT01816607
Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
An observational study of Rectal Diseases and Rectal Neoplasms, run by University Hospital, Akershus at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Diseases, Rectal Neoplasms, Gastrointestinal Diseases
- What is being tested?
- new functional magnetic resonance imaging (MRI) protocols
- Type of treatment
- Surgery or procedure
- How many people
- 192 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2013to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rectal cancer patients referred to radical surgery, with or without preoperative chemoradiotherapy.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- new functional magnetic resonance imaging (MRI) protocols
- Keywords
- Magnetic Resonance Imaging, Magnetic Resonance Imaging, Functional
- Medical subject headings
- Rectal Diseases, Rectal Neoplasms, Gastrointestinal Diseases, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new functional magnetic resonance imaging (MRI) protocolsProcedure or surgery
diffusion-weighted MRI, dynamic-contrast enhanced MRI, MR spectroscopy, blood-level oxygen dependent (BOLD) MRI
| Study group | Role | What they receive |
|---|---|---|
| Rectal cancer | Not described Receives: Procedure: new functional magnetic resonance imaging (MRI) protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of metastatic disease 5 years after rectal cancer treatment
Measured: five years
Secondary outcomes (1)
Histomorphological response to preoperative chemoradiotherapy
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rectal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, University of Oslo
- Responsible party
- Principal investigator, Kathrine Røe Redalen, University Hospital, Akershus
- Investigators
- Kathrine Røe Redalen, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816607
- Sponsor's protocol ID
- REK-2013/152
- Other IDs
- REK-2013/152
- Acronym
- OxyTarget
- Status last verified
- Nov 2018
- First submitted
- 20 Mar 2013
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30273860Grovik 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.
PubMed 28001320Bakke 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.
PubMed 41179924Bjornetro 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.
PubMed 37438741Bousquet 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.
PubMed 34961902Abrahamsson 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.
PubMed 33975557Bakke 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.
PubMed 32870132
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
- ClinicalTrials.gov ID
- NCT01816607
- Acronym / sponsor ID
- OxyTarget / REK-2013/152
- Keywords
- Magnetic Resonance Imaging, Magnetic Resonance Imaging, Functional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Oslo University Hospital, University of Oslo
- Study start
- Oct 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal cancer | – | Procedure: new functional magnetic resonance imaging (MRI) protocols |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rectal cancer patients referred to radical surgery, with or without preoperative chemoradiotherapy.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| new functional magnetic resonance imaging (MRI) protocolsdiffusion-weighted MRI, dynamic-contrast enhanced MRI, MR spectroscopy, blood-level oxygen dependent (BOLD) MRI | Procedure or surgery | Rectal cancer |
Primary outcome
Presence of metastatic disease 5 years after rectal cancer treatment
Time frame: five years
1 secondary outcome
Histomorphological response to preoperative chemoradiotherapy
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Results publication: PubMed 30273860Bousquet 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.
- Results publication: PubMed 28001320Grovik 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.
- Derived from this study: PubMed 41179924Bakke 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.
- Derived from this study: PubMed 37438741Bjornetro 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.
- Derived from this study: PubMed 34961902Bousquet 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.
- Derived from this study: PubMed 33975557Abrahamsson 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.
- Derived from this study: PubMed 32870132Bakke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathrine Røe Redalen, PhD principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Diseases and Rectal Neoplasms, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of metastatic disease 5 years after rectal cancer treatment (time frame: five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01816607, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.