An exploratory, open label phase II study to evaluate the feasibility of contrast-enhanced MRI for measurement of perfusion in squamous cell cancer of the head & neck: comparison of the intravascular contrast agent Vasovist vs. the conventional contrast agent Magnevist - Vasovist in head & neck tumors

Johann-Wolfgang Goethe-Universität0 个研究点开始时间: 2008年5月9日最近更新: 2012年3月19日

研究概览

暂无简介。

•1. Age: between 18 and 78 years
•2. Primary squamous cell carcinoma of the epi-, oro-, hypopharynx or larynx considered for surgical resection or tumor biopsy within 21 days after Vasovist-enhanced MRI
•3. Magnevist-enhanced MRI of the tumor in the head & neck region performed for clinical reasons within 3 days before the planned Vasovist-enhanced MRI
•4. Willing and able to undergo all study procedures
•5. Has personally provided written informed consent
•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

•1. Secondary cancer or history of cancer other than squamous cell carcinoma of the head & neck
•2. Patients presenting with a contraindication to MRI such as pacemaker, aneurysm clip, or severe claustrophobia
•3. History of severe allergic reaction or allergic reaction to MR contrast media
•4. Patients requiring emergency treatment
•5. Allergy to any of the ingredients of Vasovist
•6. Patients with moderate to severe renal impairment (GFR below 60 mL/min/1.73 m2 according to MDRD or Cockcroft-Gault formula using a blood creatinine value determined within 3 days before contrast agent administration)
•7. Pregnant and nursing woman (negative pregnancy test required in women of child-bearing potential – performed within 2 hours before the MR examination)
•8. Having been previously enrolled in this study
•9. Participating in another clinical trial

发起方

Johann-Wolfgang Goethe-Universität