Comparison of dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) with gadofosveset trisodium (Vasovist, Schering, Berlin, Germany) to gadopentetate dimeglumine (GD-DTPA, Magnevist, Schering) in the assessment of response to neo-adjuvant treatment with bevacizumab (Avastin) of liver metastases in patients with colorectal cancer

• Conditions: Metastatic colorectal cancer; MedDRA version: 8.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancer

• Registration Number: EUCTR2006-005530-21-BE
• Lead Sponsor: niversity Hospital Gent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-05
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with histological confirmed diagnosis of metastatic CRC, untreated yet with chemotherapy for metastatic disease (prior adjuvant chemotherapy for CRC allowed), who are scheduled to start first-line chemotherapeutic treatment.
2. Provision of signed informed consent according to ICH/GCP and the local regulations.
3. Male or female aged 18 years and above.
4. ECOG Performance status 0 or 1.
5. Neutrophils > or = 1500/µl, Platelets > or = 100000/µl, AST/ALT < or = 2.5 x ULN (< 5 x ULN if liver metastases), Alkaline phosphatase < or = 2.5 x ULN, Serum bilirubin < or = 1.5 x ULN, Serum Creatinine < or = 1.5 x ULN, Urine dipstick of proteinuria <2+.
6. One or more measurable lesions at least 10 mm in the longest diameter by spiral CT scan or 20 mm with conventional techniques according to RECIST criteria.
7. Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the study drug. She and her partner should prevent pregnancy (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) up to at least 6 months after last treatment completion or the last drug dose, whatever happens first.
8. Patient must be able to comply with the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 0.
2. Clinical or radiological evidence of CNS metastases.
3. Planned radiotherapy for underlying disease (prior completed radiotherapy treament allowed).
4. Serious non-healing wound or ulcer, evidence of bleeding diathesis or coagulopathy, uncontrolled hypertension, ongoing treatment with aspirin (>325 mg/day) or other medications known to predispose to gastrointestinal ulceration.
5. Clinical significant cardiovascular disease.
6. Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes.
7. Treatment with any investigational drug (including IMMP, EGFR inhibitors, COX-2 inhibitors) or participation in another investigational study within 30 days prior to enrolment.
8. Pregnancy (positive serum pregnancy test) and lactation.
9. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator’s opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol.
10. Included contraindication to MR imaging: pacemaker, aneurysm clip, allergy to contrast agents, clinical evidence of severe renal impairment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the objective response by DCE-MRI with Vasovist and Magnevist of bevacizumab when combined with chemotherapy regimens as first line treatment of metastatic colorectal cancer. ;Secondary Objective: To assess the optimal R0 resection and to correlate the MRI imaging and PET/CT with Mean Vessel Density (MVD), Hypoxia-Inducible Factor 1 alpha (HIF-1 alpha) and VEGF/COX-2 ratio and to identify anti-angiogenic drugs insensitive to a counteractive COX-2 dependent tumor response. An exploratory analysis will be performed between tumor response, survival and results of VEGF/COX-2 ratio and measurements with DCE-MRI and PET/CT. ;Primary end point(s): Tumor response to neo-adjuvant treatment with bevacizumab<br>Survival<br>Results of VEGF/COX-2 ratio and measurements with DCE-MRI and PET/CT