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

Conditions

Intervention / Treatment

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

  • United States
    • 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
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

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

University of Wisconsin, Madison

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.

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