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

This study has been terminated.
(change in imaging priorities)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
First received: December 21, 2007
Last updated: February 22, 2012
Last verified: February 2012
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 Intervention
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
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 9
Study Start Date: December 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585117     History of Changes
Other Study ID Numbers: HSC 2006-0282  RO06309 
Study First Received: December 21, 2007
Last Updated: February 22, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 03, 2016