Rectal Neoplasms Clinical Trial
— OxyTargetOfficial title:
Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
Verified date | November 2018 |
Source | University Hospital, Akershus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Norway | Akershus University Hospital | Lørenskog | Akershus |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Akershus | Oslo University Hospital, University of Oslo |
Norway,
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
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 |
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