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

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ClinicalTrials.gov Identifier: NCT00585117
Recruitment Status : Terminated (change in imaging priorities)
First Posted : January 3, 2008
Last Update Posted : February 24, 2012
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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

Condition or disease Intervention/treatment
CNS Brain Metastases Head and Neck Cancer Lung Cancer Prostate Cancer Esophageal Cancer Procedure: PET-imaging with CuATSM Procedure: PET Imaging Procedure: PET CuATSM Procedure: PET imaging Procedure: PET imaging with CuATSM

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : December 2006
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 CNS
imaging with CuATSM
Procedure: PET-imaging with CuATSM
imaging with CuATSM
Procedure: PET Imaging
Imaging with CuATSM
Experimental: 2. Head and Neck
Imaging with CuATSM
Procedure: PET CuATSM
Imaging with CuATSM
Experimental: 3. Lung
imaging with CuATSM
Procedure: PET imaging
imaging with CuATSM
Experimental: 4. Prostate
PET imaging with CuATSM
Procedure: PET imaging with CuATSM
Imaging with CuATSM
Experimental: 5. Esophagus
PET imaging with CuATSM
Procedure: PET imaging with CuATSM
Imaging with CuATSM

Primary Outcome Measures :
  1. To validate the CuATSM-PET imaging by correlation to the serum level of osteopontin, a marker of hypoxia [ Time Frame: end of study ]

Secondary Outcome Measures :
  1. To test reliability of the CuATSM uptake by quantifying the reproducibility of the pre-treatment CuATSM_PET scans [ Time Frame: end of study ]
  2. To assess the technical and logistic feasibility of CuATSM-PET scans in a population of cancer patients [ Time Frame: end of study ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585117

United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Robert Jeraj, Ph.D University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585117     History of Changes
Other Study ID Numbers: HSC 2006-0282
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: February 24, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Head and Neck Neoplasms
Esophageal Neoplasms
Neoplasms by Site
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases