NCT00968656

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

2.8 years

First QC Date

August 28, 2009

Last Update Submit

December 8, 2014

Conditions

Breast CancerHead and Neck CancerDiffuse Large B-cell Lymphoma

Keywords

Breast cancerHead and Neck CancerDiffuse Large B-cell lymphomaCellular proliferation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (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.

    3 years

Interventions

PET/CTRADIATION

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

Laboratory TestingOTHER

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

Safety TestingOTHER

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 stainingOTHER

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

F-18-ISODRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to tolerate 60-90 minutes of PET imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University / Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsHead and Neck NeoplasmsLymphoma, Large B-Cell, DiffuseHyperplasia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Farrokh Dehdashti, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiology

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

January 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations

US(1)