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PET/MRI Perfusion and CT Perfusion in Solid Tumors (Perfusion)

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ClinicalTrials.gov Identifier: NCT02314962
Recruitment Status : Terminated (Slow enrolment)
First Posted : December 11, 2014
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date October 23, 2014
First Posted Date December 11, 2014
Last Update Posted Date December 16, 2016
Study Start Date December 2014
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 8, 2014)
Measurement of blood flow, blood volume and transfer constant (Ktrans) with CT-Perfusion and PET/MR-perfusion in solid tumors. [ Time Frame: 18 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02314962 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 8, 2014)
Correlation of blood flow, blood volume and transfer constant (Ktrans) measured with CT-Perfusion and PET/MR-perfusion with progression free survival in solid tumors. [ Time Frame: 18 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 11, 2014)
  • Measurement of blood flow (mL/100 mg tissue/min) with CT-Perfusion and PET/MR-perfusion in solid tumors. [ Time Frame: 18 months ]
  • Measurement of blood volume (mL/100 mg tissue) with CT-Perfusion and PET/MR-perfusion in solid tumors. [ Time Frame: 18 months ]
  • Measurement of transfer constant with PET/MR-perfusion in solid tumors. [ Time Frame: 18 months ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PET/MRI Perfusion and CT Perfusion in Solid Tumors
Official Title Diagnostic and Clinical Accuracy of Integrated Magnetic Resonance Imaging and Computed Tomography Perfusion in PET/MRI in Comparison to PET/CT in Solid Tumors
Brief Summary Diagnostic comparison between PET/CT and PET/MRI with integrated perfusion measurement in CT and MR. Study aim is to gain knowledge about additional value of CT perfusion and MR perfusion in solid tumors concerning tumor physiology, diagnostic accuracy and possibly prognostic.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with suspected or confirmed solid malignant tumors of the neck, chest or abdomen who have an indication for a PET/CT
Condition CT Perfusion and MRI Perfusion in Solid Tumors
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: June 17, 2016)
43
Original Estimated Enrollment
 (submitted: December 8, 2014)
200
Actual Study Completion Date December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • indication as stated above
  • written informed consent
  • patients with suspected or confirmed solid malignant tumors of the neck, chest or abdomen who have an indication for a PET/CT

Exclusion Criteria:

  • pregnant or breast feeding women
  • non compliance of the patient to follow the study instructions (e.g. hearing problems, dementia)
  • Inclusion in another clinical trial 30 days prior to inclusion
  • age < 30years
  • contraindication for MRI (cardiac pacemaker, certain metal implants, claustrophobia
  • known allergies to contrast CT or MRI contrast media
  • patients with an glomerular filtration rate of < 60ml/min/1.73m2
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02314962
Other Study ID Numbers KEK ZH Nr 20140077
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators Not Provided
Investigators
Principal Investigator: Patrick Veit-Haibach, MD University Hospital Zurich, Diagnostic and Interventional Radiology
PRS Account University of Zurich
Verification Date December 2016