ClinicalTrials.gg
CompletedNCT01816607OxyTargetUpdated Nov 19, 2018

Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness

An observational study in Rectal Diseases, Rectal Neoplasms and Gastrointestinal Diseases, sponsored by University Hospital, Akershus. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-19.

Primary conditionRectal NeoplasmsRegistry: Rectal DiseasesReclassifiedWhy we changed it
Registry
Rectal Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Rectal Neoplasms
Why
  1. The study's listed conditions name Rectal Neoplasms, a narrower term within Rectal Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University Hospital, Akershus · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
192
Ages
18 Years and older
Sex
All
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Where this study stands

Counted across the records on this site · 2026-11-12

Among 25 studies in Rectal Neoplasms with a site in Norway — 6 open to participants now, 12 under way, 3 of them phase 3. Rectal Neoplasms · Norway.

Enrollment
6th of 11
192 · median 192
Started
2013
with 1 other
Observational
11 of 25
4 open now
Registered
8th of 25
by date

Among the 25 studies in Rectal Neoplasms with a site in Norway, this one is the 6th largest by enrollment of the 11 observational ones, is one of 2 that started in 2013, is one of 11 observational ones, and was the 8th registered.

By phase

25 studies; the count open now beside each. This study's row is marked.

Observationalthis study11 · 4 open
Phase 35 · 1 open
No phase4 · 1 open
Phase 24 · 0 open
Phase 41 · 0 open

By the year they started

First in 1998; this study’s year is marked. 2 started in 2013.

Size and results

Median enrollment 106 across the 13 interventional studies, 192 across the 11 observational. Of the 12 that completed or were terminated, 1 (8%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 25 studies in Rectal Neoplasms with a site in Norway, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Rectal Diseases
  • Rectal Neoplasms
  • Gastrointestinal Diseases
  • Gastrointestinal Neoplasms

Keywords

  • Magnetic Resonance Imaging
  • Magnetic Resonance Imaging, Functional
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In context

Rectal Neoplasms Reclassified

2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.

This study's enrollment of 192 is above the median of 161 across 498 observational studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

University Hospital, Akershus is the lead sponsor of 125 studies on the registry; 28 are open to participants now.

Compared within Rectal Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Rectal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Rectal cancer patients referred to radical surgery, with or without preoperative chemoradiotherapy.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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: ≥ 60 ml/minute.
  • The patient has signed the written according to the protocol approved by the Regional Ethics Committee.

Exclusion criteria

Exclusion Criteria:

  • The patient has to MRI or MRI contrast agent according to clinical practice.
  • The patient wants to withdraw for any reason during the study.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

06

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
192 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Rectal cancer

    Procedure: new functional magnetic resonance imaging (MRI) protocols

Interventions

  • Procedurenew functional magnetic resonance imaging (MRI) protocols

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

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What researchers measure

Primary outcomes

  1. Presence of metastatic disease 5 years after rectal cancer treatment

    Time frame: five years

Secondary outcomes

  1. Histomorphological response to preoperative chemoradiotherapy

    Time frame: 8 weeks

Other outcomes

  1. Detection of regional malignant lymph nodes at time of diagnosis

    Time frame: 8 weeks

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Study locations

1 site
  • Akershus University Hospital
    Lørenskog, Akershus 1478, Norway
09

References and documents

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 30273860 ↗
  • 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. PubMed 28001320 ↗
  • 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. PubMed 34961902 ↗
  • 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. PubMed 33975557 ↗
  • 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. PubMed 32870132 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2013, a primary completion of Dec 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2013
First posted
Mar 22, 2013
Start
Oct 2013
Primary completionActual
Dec 2017
CompletionActual
Dec 2017
Last update
Nov 19, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01816607
Responsible party
Kathrine Røe Redalen (Senior scientist, University Hospital, Akershus) — Principal investigator
First posted
Mar 22, 2013
Start date
Oct 2013
Primary completion
Dec 2017
Completion
Dec 2017
Last update
Nov 19, 2018

Study contacts

Kathrine Røe Redalen, PhD
principal investigator · University Hospital, Akershus

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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