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

NCT ID: NCT00585117

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2012-01-31

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1 CNS

imaging with CuATSM

Group Type EXPERIMENTAL

PET-imaging with CuATSM

Intervention Type PROCEDURE

imaging with CuATSM

PET Imaging

Intervention Type PROCEDURE

Imaging with CuATSM

2. Head and Neck

Imaging with CuATSM

Group Type EXPERIMENTAL

PET CuATSM

Intervention Type PROCEDURE

Imaging with CuATSM

3. Lung

imaging with CuATSM

Group Type EXPERIMENTAL

PET imaging

Intervention Type PROCEDURE

imaging with CuATSM

4. Prostate

PET imaging with CuATSM

Group Type EXPERIMENTAL

PET imaging with CuATSM

Intervention Type PROCEDURE

Imaging with CuATSM

5. Esophagus

PET imaging with CuATSM

Group Type EXPERIMENTAL

PET imaging with CuATSM

Intervention Type PROCEDURE

Imaging with CuATSM

Interventions

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PET-imaging with CuATSM

imaging with CuATSM

Intervention Type PROCEDURE

PET Imaging

Imaging with CuATSM

Intervention Type PROCEDURE

PET CuATSM

Imaging with CuATSM

Intervention Type PROCEDURE

PET imaging

imaging with CuATSM

Intervention Type PROCEDURE

PET imaging with CuATSM

Imaging with CuATSM

Intervention Type PROCEDURE

PET imaging with CuATSM

Imaging with CuATSM

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Jeraj, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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RO06309

Identifier Type: OTHER

Identifier Source: secondary_id

A533300

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\HUMAN ONCOLOGY\HUMAN ONCO

Identifier Type: OTHER

Identifier Source: secondary_id

HSC 2006-0282

Identifier Type: -

Identifier Source: org_study_id