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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00968656
Recruitment Status : Completed
First Posted : August 31, 2009
Last Update Posted : December 9, 2014
Isotrace Technologies
Information provided by (Responsible Party):
Farrokh Dehdashti, Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Head and Neck Cancer Diffuse Large B-cell Lymphoma Radiation: PET/CT Other: Laboratory Testing Other: Safety Testing Other: Immunohistochemistry staining Drug: F-18-ISO Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Cellular Proliferation in Tumors by Positron Emission Tomography (PET) Using [18F]ISO-1
Study Start Date : January 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. The primary out come is to assess the diagnostic quality of [18F]ISO-1-PET/CT images at the proposed 8 mCi dose. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Secondary outcome is to quantitatively determine the relationship between tumor [18F]ISO-1 uptake and Ki-67, S-phase, mitotic index and sigma-2 receptors content of the tumor. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients 18 years of age or older with biopsy-proven breast cancer, head & neck cancer or diffuse large B-cell lymphoma.
  • 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.

Exclusion Criteria:

  • Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years. Lymphoma patients who have received treatment in the past but have a new diagnosis of diffuse large B-cell lymphoma are eligible to participate providing they will undergo tissue sampling as specified in the inclusion criteria.
  • Unable to tolerate 60-90 minutes of PET imaging.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00968656

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United States, Missouri
Washington University / Barnes Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Isotrace Technologies
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Principal Investigator: Farrokh Dehdashti, M.D. Washington University School of Medicine

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Responsible Party: Farrokh Dehdashti, Professor of Radiology, Washington University School of Medicine Identifier: NCT00968656     History of Changes
Other Study ID Numbers: FISO 08-1010
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014
Keywords provided by Farrokh Dehdashti, Washington University School of Medicine:
Breast cancer
Head and Neck Cancer
Diffuse Large B-cell lymphoma
Cellular proliferation
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Lymphoma, Non-Hodgkin
Pathologic Processes