Study Stopped
change in imaging priorities
Pilot Study of (61)CuATSM-PET Imaging in Cancer Patients
4 other identifiers
interventional
9
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedDecember 13, 2019
February 1, 2012
5.1 years
December 21, 2007
December 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
To validate the CuATSM-PET imaging by correlation to the serum level of osteopontin, a marker of hypoxia
end of study
Secondary Outcomes (2)
To test reliability of the CuATSM uptake by quantifying the reproducibility of the pre-treatment CuATSM_PET scans
end of study
To assess the technical and logistic feasibility of CuATSM-PET scans in a population of cancer patients
end of study
Study Arms (5)
1 CNS
EXPERIMENTALimaging with CuATSM
2. Head and Neck
EXPERIMENTALImaging with CuATSM
3. Lung
EXPERIMENTALimaging with CuATSM
4. Prostate
EXPERIMENTALPET imaging with CuATSM
5. Esophagus
EXPERIMENTALPET imaging with CuATSM
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- severe claustrophobia or inability to tolerate the PET scan
- pregnant or breastfeeding women
- Patients that need supplemental oxygen
- Patients enrolled in experimental treatments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Jeraj, Ph.D
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 3, 2008
Study Start
December 1, 2006
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
December 13, 2019
Record last verified: 2012-02