Assessment of Cellular Proliferation in Tumors by Positron Emission Tomography (PET) Using [18F]ISO-1
NCT ID: NCT00968656
Last Updated: 2014-12-09
Study Results
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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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2009-01-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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PET/CT
Patients receive F-18-ISO-1 i.v. and undergo PET/CT imaging at 2-3 time points following the injection.
Laboratory Testing
Blood and urine samples for laboratory analysis and radioactive counts will be obtained during the imaging sessions
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.
Immunohistochemistry staining
If available tissue from a biopsy or surgery will be tested cellular proliferation markers such as Ki67 and sigma 2 receptors
F-18-ISO
Patients receive F-18-ISO-1 i.v.
Eligibility Criteria
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Inclusion Criteria
* For determination of Ki-67, S-phase, mitotic index, and sigma-2 receptor assessment, cancer subjects must be scheduled to undergo surgical resection of the primary tumor without intervening therapy, or be scheduled to undergo (or have already undergone) tissue sampling as either standard of care or part of another research project prior to any planned treatment for their cancer. For tumor sigma-2 receptors assessment, about 0.5 g of fresh tumor tissue kept frozen on dry ice is needed, other proliferative markers may be determined on a much smaller specimen. Thus, it is possible that the analysis of sigma-2 receptors may not be possible in all patients, as obtaining 0.5 g tumor specimen may not practical in all patients.
* Newly diagnosed breast cancer, head \& neck cancer, or diffuse large B-cell lymphoma subjects should have a primary lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination and who have not received any treatment for their cancer.
* Able to give informed consent.
* Not currently pregnant or nursing: Female subjects must be either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), or post menopausal (cessation of menses for more than 1 year). If of childbearing potential, a urine pregnancy test must be performed within the 24 hour period immediately prior to administration of \[18F\]ISO-1 and determined to be negative.
* Unable to tolerate 60-90 minutes of PET imaging.
18 Years
ALL
No
Sponsors
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Isotrace Technologies
UNKNOWN
Washington University School of Medicine
OTHER
Responsible Party
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Farrokh Dehdashti
Professor of Radiology
Principal Investigators
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Farrokh Dehdashti, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University / Barnes Jewish Hospital
St Louis, Missouri, United States
Countries
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Other Identifiers
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FISO 08-1010
Identifier Type: -
Identifier Source: org_study_id