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

This study has been terminated.
(change in imaging priorities)
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Neoplasm Metastasis
Prostatic Neoplasms
Brain Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
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 July 26, 2014