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

Primary Purpose

CNS Brain Metastases, Head and Neck Cancer, Lung Cancer

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PET-imaging with CuATSM

PET Imaging

PET CuATSM

PET imaging

PET imaging with CuATSM

About this trial

This is an interventional diagnostic trial for CNS Brain Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Wisconsin Hospital and Clinics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

1 CNS

2. Head and Neck

3. Lung

4. Prostate

5. Esophagus

Arm Description

imaging with CuATSM

Imaging with CuATSM

imaging with CuATSM

PET imaging with CuATSM

Outcomes

Primary Outcome Measures

To validate the CuATSM-PET imaging by correlation to the serum level of osteopontin, a marker of hypoxia

Secondary Outcome Measures

To test reliability of the CuATSM uptake by quantifying the reproducibility of the pre-treatment CuATSM_PET scans

To assess the technical and logistic feasibility of CuATSM-PET scans in a population of cancer patients

Full Information

NCT ID

NCT00585117

First Posted

December 21, 2007

Last Updated

December 12, 2019

Sponsor

University of Wisconsin, Madison

1. Study Identification

Unique Protocol Identification Number

NCT00585117

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Terminated

Why Stopped

change in imaging priorities

Study Start Date

December 2006 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CNS Brain Metastases, Head and Neck Cancer, Lung Cancer, Prostate Cancer, Esophageal Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 CNS

Arm Type

Experimental

Arm Description

imaging with CuATSM

Arm Title

2. Head and Neck

Arm Type

Experimental

Arm Description

Imaging with CuATSM

Arm Title

3. Lung

Arm Type

Experimental

Arm Description

imaging with CuATSM

Arm Title

4. Prostate

Arm Type

Experimental

Arm Description

PET imaging with CuATSM

Arm Title

5. Esophagus

Arm Type

Experimental

Arm Description

PET imaging with CuATSM

Intervention Type

Procedure

Intervention Name(s)

PET-imaging with CuATSM

Intervention Description

imaging with CuATSM

Intervention Type

Procedure

Intervention Name(s)

PET Imaging

Intervention Description

Imaging with CuATSM

Intervention Type

Procedure

Intervention Name(s)

PET CuATSM

Intervention Description

Imaging with CuATSM

Intervention Type

Procedure

Intervention Name(s)

PET imaging

Intervention Description

imaging with CuATSM

Intervention Type

Procedure

Intervention Name(s)

PET imaging with CuATSM

Intervention Description

Imaging with CuATSM

Intervention Type

Procedure

Intervention Name(s)

PET imaging with CuATSM

Intervention Description

Imaging with CuATSM

Primary Outcome Measure Information:

Title

To validate the CuATSM-PET imaging by correlation to the serum level of osteopontin, a marker of hypoxia

Time Frame

end of study

Secondary Outcome Measure Information:

Title

To test reliability of the CuATSM uptake by quantifying the reproducibility of the pre-treatment CuATSM_PET scans

Time Frame

end of study

Title

To assess the technical and logistic feasibility of CuATSM-PET scans in a population of cancer patients

Time Frame

end of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Jeraj, Ph.D

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Wisconsin Hospital and Clinics

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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