Pilot Study of (61)CuATSM-PET Imaging in Cancer Patients
This study has been terminated.
(change in imaging priorities)
Sponsor:
University of Wisconsin, Madison
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585117
First received: December 21, 2007
Last updated: February 22, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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:
MedlinePlus related topics:
Cancer
Esophageal Cancer
Esophagus Disorders
Head and Neck Cancer
Lung Cancer
Nuclear Scans
Prostate Cancer
U.S. FDA Resources
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585117
Locations
| United States, Wisconsin | |
| 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 |
More Information
No publications provided
| 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 Diseases Esophageal Neoplasms Head and Neck Neoplasms Lung Neoplasms Neoplasm Metastasis Prostatic Neoplasms Brain Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Neoplastic Processes Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Central Nervous System Neoplasms Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013