Functional MRI of Hypoxia-mediated Rectal Cancer Aggressi... | NCT01816607

Studies
Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness

NCT01816607

Sponsor

University Hospital, Akershus

Status

Completed

Last Update Posted

Nov 19, 2018Actual

Enrollment

192Actual

Phase

Not provided

Conditions

Rectal Diseases
Rectal Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms

Interventions

new functional magnetic resonance imaging (MRI) protocols

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
REK-2013/152	Other Grant/Funding Number	HSØ_2013002

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Mar 20, 2013

First Submission Date that Met QC Criteria

Mar 20, 2013

First Posted Date

Mar 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2018

Last Update Posted Date

Nov 19, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kathrine Røe Redalen, Senior scientist, University Hospital, AkershusPrincipal Investigator

Lead Sponsor

University Hospital, AkershusOTHER

Collaborators

Name	Class
Oslo University Hospital	OTHER
University of Oslo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

192Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rectal cancer			Procedure: new functional magnetic resonance imaging (MRI) protocols

Interventions

Name	Type	Description	Arm Group Labels	Other Names
new functional magnetic resonance imaging (MRI) protocols	Procedure	diffusion-weighted MRI, dynamic-contrast enhanced MRI, MR spectroscopy, blood-level oxygen dependent (BOLD) MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of metastatic disease 5 years after rectal cancer treatment		five years

Secondary Outcomes

Measure	Description	Time Frame
Histomorphological response to preoperative chemoradiotherapy		8 weeks

Other Outcomes

Measure	Description	Time Frame
Detection of regional malignant lymph nodes at time of diagnosis		8 weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kathrine Røe Redalen, PhD	University Hospital, Akershus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akershus University Hospital		Lørenskog	Akershus	1478	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30273860	Result	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.
28001320

ID	Term
D007410	Intestinal Diseases
D004066	Digestive System Diseases
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

ID	Term
D012002	Rectal Diseases
D012004	Rectal Neoplasms
D005767	Gastrointestinal Diseases
D005770	Gastrointestinal Neoplasms