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Assessment of Cellular Proliferation in Tumors by Positron Emission Tomography (PET) Using [18F]ISO-1

NCT00968656 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2014-12-09

No results posted yet for this study

Summary

The main purpose of this study is to see if Positron Emission Tomography (PET) imaging with a radioactive tracer called 18F-ISO-1 can accurately identify how quickly cancer cells are growing or dividing. A second purpose for this study is to determine, by taking pictures, what tissues and organs of the body take up 18F-ISO-1 naturally and to determine how that uptake changes over time.

Conditions

Interventions

RADIATION

PET/CT

Patients receive F-18-ISO-1 i.v. and undergo PET/CT imaging at 2-3 time points following the injection.

OTHER

Laboratory Testing

Blood and urine samples for laboratory analysis and radioactive counts will be obtained during the imaging sessions

OTHER

Safety Testing

ECG tracings, and vital signs (blood pressure, heart rate, body temperature and respiration rate) are obtained at several time points before, during, and after the imaging sessions.

OTHER

Immunohistochemistry staining

If available tissue from a biopsy or surgery will be tested cellular proliferation markers such as Ki67 and sigma 2 receptors

DRUG

F-18-ISO

Patients receive F-18-ISO-1 i.v.

Sponsors & Collaborators

  • Isotrace Technologies

    collaborator UNKNOWN

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Farrokh Dehdashti, M.D. · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00968656 on ClinicalTrials.gov