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

Breast Cancer Clinical Trial

— FISO PET/CT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968656
• Other study ID #: FISO 08-1010
• Status: Completed
• Phase: Phase 1
• First received: August 28, 2009
• Last updated: December 8, 2014
• Start date: January 2009
• Est. completion date: November 2011

Study information

• Verified date: December 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Diffuse Large B-cell Lymphoma
• Head and Neck Cancer
• Head and Neck Neoplasms
• Hyperplasia
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

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
• 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

Drug:
• F-18-ISO
Patients receive F-18-ISO-1 i.v.

Locations

Country	Name	City	State
United States	Washington University / Barnes Jewish Hospital	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Isotrace Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary out come is to assess the diagnostic quality of [18F]ISO-1-PET/CT images at the proposed 8 mCi dose.		3 years	No
Secondary	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.		3 years	No