Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness

Rectal Neoplasms Clinical Trial

— OxyTarget  

Official title:

Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816607
• Other study ID #: REK-2013/152
• Secondary ID: REK-2013/152
• Status: Completed
• Start date: October 2013
• Est. completion date: December 2017

Study information

• Verified date: November 2018
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aggression
• Digestive System Diseases
• Digestive System Neoplasms
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Hypoxia
• Neoplasms
• Rectal Diseases
• Rectal Neoplasms

Intervention

Procedure:
• new functional magnetic resonance imaging (MRI) protocols
diffusion-weighted MRI, dynamic-contrast enhanced MRI, MR spectroscopy, blood-level oxygen dependent (BOLD) MRI

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog	Akershus

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Akershus	Oslo University Hospital, University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Bousquet PA, Meltzer S, Sønstevold 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. Trans — View Citation

Grøvik E, Redalen KR, Storås TH, Negård A, Holmedal SH, Ree AH, Meltzer S, Bjørnerud A, Gjesdal KI. Dynamic multi-echo DCE- and DSC-MRI in rectal cancer: Low primary tumor K(trans) and ?R2* peak are significantly associated with lymph node metastasis. J M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Detection of regional malignant lymph nodes at time of diagnosis		8 weeks
Primary	Presence of metastatic disease 5 years after rectal cancer treatment		five years
Secondary	Histomorphological response to preoperative chemoradiotherapy		8 weeks