Pilot Study of (61)CuATSM-PET Imaging in Cancer Patients

This study has been terminated.
(change in imaging priorities)
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585117
First received: December 21, 2007
Last updated: February 22, 2012
Last verified: February 2012

December 21, 2007
February 22, 2012
December 2006
January 2012   (final data collection date for primary outcome measure)
To validate the CuATSM-PET imaging by correlation to the serum level of osteopontin, a marker of hypoxia [ Time Frame: end of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00585117 on ClinicalTrials.gov Archive Site
  • To test reliability of the CuATSM uptake by quantifying the reproducibility of the pre-treatment CuATSM_PET scans [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • To assess the technical and logistic feasibility of CuATSM-PET scans in a population of cancer patients [ Time Frame: end of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pilot Study of (61)CuATSM-PET Imaging in Cancer Patients
Not Provided

Hypoxia is a key factor in malignant progression of a neoplasm. It is our aim to explore the basis for quantitative in vivo tumor imaging by Cu-61 diacetyl-bis(N4-methylthiosemicarbazone)PET imaging as a surrogate of tissue hypoxia. We hypothesize that the hypoxia levels are predictive of the tumor response to therapy. Patients will have 2 CU-ATSM PET scans done and the goal is to show spatially stable tracer distributions that correlate with tumor hypoxia. This study will serve as a pilot study for a PO1 submission

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • CNS Brain Metastases
  • Head and Neck Cancer
  • Lung Cancer
  • Prostate Cancer
  • Esophageal Cancer
  • Procedure: PET-imaging with CuATSM
    imaging with CuATSM
  • Procedure: PET Imaging
    Imaging with CuATSM
  • Procedure: PET CuATSM
    Imaging with CuATSM
  • Procedure: PET imaging
    imaging with CuATSM
  • Procedure: PET imaging with CuATSM
    Imaging with CuATSM
  • Experimental: 1 CNS
    imaging with CuATSM
    Interventions:
    • Procedure: PET-imaging with CuATSM
    • Procedure: PET Imaging
  • Experimental: 2. Head and Neck
    Imaging with CuATSM
    Intervention: Procedure: PET CuATSM
  • Experimental: 3. Lung
    imaging with CuATSM
    Intervention: Procedure: PET imaging
  • Experimental: 4. Prostate
    PET imaging with CuATSM
    Intervention: Procedure: PET imaging with CuATSM
  • Experimental: 5. Esophagus
    PET imaging with CuATSM
    Intervention: Procedure: PET imaging with CuATSM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Able to tolerated a PET/CT scan
  • Age 18 or older
  • Patient being considered for XRT for treatment of their cancer
  • Able to provide written informed consent

Exclusion Criteria:

  • severe claustrophobia or inability to tolerate the PET scan
  • pregnant or breastfeeding women
  • Patients that need supplemental oxygen
  • Patients enrolled in experimental treatments
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585117
HSC 2006-0282, RO06309
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Robert Jeraj, Ph.D University of Wisconsin, Madison
University of Wisconsin, Madison
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP