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

Not Applicable

Terminated

• Conditions: CNS Brain Metastases; Prostate Cancer; Esophageal Cancer; Lung Cancer; Head and Neck Cancer
• Interventions: Procedure: PET imaging; Procedure: PET CuATSM; Procedure: PET imaging with CuATSM; Procedure: PET-imaging with CuATSM

• Registration Number: NCT00585117
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-03
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3. Lung	PET imaging	imaging with CuATSM
2. Head and Neck	PET CuATSM	Imaging with CuATSM
1 CNS	PET imaging	imaging with CuATSM
4. Prostate	PET imaging with CuATSM	PET imaging with CuATSM
1 CNS	PET-imaging with CuATSM	imaging with CuATSM
5. Esophagus	PET imaging with CuATSM	PET imaging with CuATSM

Primary Outcome Measures

Name	Time	Method
To validate the CuATSM-PET imaging by correlation to the serum level of osteopontin, a marker of hypoxia	end of study

Secondary Outcome Measures

Name	Time	Method
To assess the technical and logistic feasibility of CuATSM-PET scans in a population of cancer patients	end of study
To test reliability of the CuATSM uptake by quantifying the reproducibility of the pre-treatment CuATSM_PET scans	end of study

Trial Locations

Locations (1)

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States