- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00585117
Pilot Study of (61)CuATSM-PET Imaging in Cancer Patients
December 12, 2019 updated by: University of Wisconsin, Madison
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
Study Overview
Status
Terminated
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital and Clinics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 CNS
imaging with CuATSM
|
imaging with CuATSM
Imaging with CuATSM
|
Experimental: 2. Head and Neck
Imaging with CuATSM
|
Imaging with CuATSM
|
Experimental: 3. Lung
imaging with CuATSM
|
imaging with CuATSM
|
Experimental: 4. Prostate
PET imaging with CuATSM
|
Imaging with CuATSM
|
Experimental: 5. Esophagus
PET imaging with CuATSM
|
Imaging with CuATSM
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To validate the CuATSM-PET imaging by correlation to the serum level of osteopontin, a marker of hypoxia
Time Frame: end of study
|
end of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To test reliability of the CuATSM uptake by quantifying the reproducibility of the pre-treatment CuATSM_PET scans
Time Frame: end of study
|
end of study
|
To assess the technical and logistic feasibility of CuATSM-PET scans in a population of cancer patients
Time Frame: end of study
|
end of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Jeraj, Ph.D, University of Wisconsin, Madison
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
December 21, 2007
First Posted (Estimate)
January 3, 2008
Study Record Updates
Last Update Posted (Actual)
December 13, 2019
Last Update Submitted That Met QC Criteria
December 12, 2019
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC 2006-0282
- A533300 (Other Identifier: UW Madison)
- RO06309 (Other Identifier: UW Carbone Cancer Center)
- SMPH\HUMAN ONCOLOGY\HUMAN ONCO (Other Identifier: UW Madison)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Cancer
-
Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
-
Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
-
Mayo ClinicRecruitingCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
-
IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
-
University of California, San FranciscoCompleted
-
Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
Radboud University Medical CenterUnknown
-
WepromNeptuneActive, not recruitingMetastatic Colorectal Cancer | Metastatic Head and Neck CancerFrance
Clinical Trials on PET-imaging with CuATSM
-
King's College LondonGuy's and St Thomas' NHS Foundation TrustSuspendedCarotid AtherosclerosisUnited Kingdom
-
Nicole HillBlue Earth Diagnostics; Barrow Neurological FoundationRecruitingGrade III or Grade IV GliomaUnited States
-
Phoenix Molecular ImagingWithdrawn
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedMelanoma | Lymphoma | Unspecified Childhood Solid Tumor, Protocol Specific | Head and Neck Cancer | Lung Cancer | Unspecified Adult Solid Tumor, Protocol Specific | Colon Cancer | Malignant NeoplasmUnited States
-
Aposense Ltd.UnknownHead and Neck Neoplasms | Carcinoma, Non-Small-Cell LungUnited States
-
Balaji TamarappooCompleted
-
Alan NicholCompletedCancer (High-grace Glioma)Canada
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI); National Institutes of Health (NIH)Recruiting
-
Kepler University HospitalRecruiting
-
Stanford UniversityRecruiting