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

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00585117
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arms: 5
• Duration (Months): 61
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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	Phase
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; Procedure: PET imaging with CuATSM	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

2. To assess the technical and logistic feasibility of CuATSM-PET scans in a population of cancer patients [end of study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• University of Wisconsin, Madison

Investigators

• Principal Investigator: Robert Jeraj, Ph.D, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00585117
• Other Study ID Numbers: HSC 2006-0282; RO06309; A533300; SMPH\HUMAN ONCOLOGY\HUMAN ONCO
• First Posted: Jan 3, 2008
• Last Update Posted: Dec 13, 2019
• Last Verified: Feb 1, 2012

• Additional relevant MeSH terms: Brain Neoplasms

Study Results

No Results Posted as of Dec 13, 2019