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

Prostate Cancer Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00585117
• Other study ID #: HSC 2006-0282
• Secondary ID: RO06309A533300SM
• Status: Terminated
• Phase: N/A
• Start date: December 2006
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CNS Brain Metastases
• Esophageal Cancer
• Head and Neck Cancer
• Lung Cancer
• Prostate Cancer

Intervention

Procedure:
• PET-imaging with CuATSM
imaging with CuATSM
• PET Imaging
Imaging with CuATSM
• PET CuATSM
Imaging with CuATSM
• PET imaging
imaging with CuATSM
• PET imaging with CuATSM
Imaging with CuATSM
• PET imaging with CuATSM
Imaging with CuATSM

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To validate the CuATSM-PET imaging by correlation to the serum level of osteopontin, a marker of hypoxia		end of study
Secondary	To test reliability of the CuATSM uptake by quantifying the reproducibility of the pre-treatment CuATSM_PET scans		end of study
Secondary	To assess the technical and logistic feasibility of CuATSM-PET scans in a population of cancer patients		end of study