Positron Emission Tomography Using Fluorine F 18 EF5 to Find Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Newly Diagnosed Brain Tumors - Full Text View

Sponsors and Collaborators:	University of Pennsylvania National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00110032

Purpose

RATIONALE: Diagnostic procedures using fluorine F 18 EF5 and positron emission tomography to detect tumor hypoxia may help in planning cancer treatment.

PURPOSE: This phase I trial is studying the side effects of fluorine F18 EF5 when given during positron emission tomography to find oxygen in tumor cells of patients who are undergoing surgery or biopsy for newly diagnosed brain tumors.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: EF5 Drug: fluorine F 18 EF5 Procedure: conventional surgery Procedure: positron emission tomography	Phase I

MedlinePlus related topics: Brain Cancer Cancer

Drug Information available for: Fluoride Sodium fluoride Stannous fluoride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	A Preliminary Investigation of the Biodistribution of [F-18]-EF5 in Patients With Brain Tumors

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Safety by common toxicity criteria (CTC v.2) from the day before craniotomy to 2-4 weeks after [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics and biodistribution of radioactively labeled [F-18]-EF5 given before vs. after non-radioactive EF5 on the day before surgery [ Designated as safety issue: No ]
Hypoxia detection ability of PET scanning with [F-18]-EF5 by immunohistochemistry (IHC) and/or flow cytometry (FCM) on the day before surgery [ Designated as safety issue: No ]

Estimated Enrollment:	46
Study Start Date:	June 2005

Detailed Description:

OBJECTIVES:

Determine the safety of fluorine F 18 EF5 (^18F-EF5) in patients with newly diagnosed brain tumors undergoing surgery or biopsy.

Secondary

Determine the pharmacokinetics and biodistribution of ^18F-EF5 administered before and after nonradioactive EF5 in these patients.
Determine the ability of positron emission tomography (PET) scanning using ^18F-EF5 to detect tumor hypoxia in these patients.
Determine the presence and pattern of nonradioactive EF5 binding by immunohistochemistry (IHC) and/or flow cytometry in these patients.
Correlate tumor hypoxia, as measured by PET scanning using ^18F-EF5, with EF5 staining by IHC and/or flow cytometry and recurrence-free survival of these patients.

OUTLINE: Patients are assigned to 1 of 3 groups.

Group 1: Patients receive fluorine F 18 EF5 (^18F-EF5) IV followed by whole brain and whole body positron emission tomography (PET) scanning OR whole body PET scanning only. Patients then receive nonradioactive EF5 IV over 1-2 ½ hours.
Group 2: Patients receive nonradioactive EF5 IV over 1-2½ hours followed by ^18F-EF5 IV. Patients then undergo whole brain and whole body PET scanning.
Group 3: Patients receive nonradioactive EF5 and ^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning.

Approximately one day after EF5 administration, all patients undergo surgery or biopsy of the tumor AND biopsy of normal skin adjacent to the incision.

Patients are followed at 2-4 weeks and 4-6 weeks after EF5 administration and then every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 46 patients (6 each in groups 1 and 2, 34 in group 3) will be accrued for this study within 5 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed and/or clinical and imaging evidence of a de novo mass that is likely to be a brain tumor
Amenable to debulking surgery or surgical resection or biopsy as standard initial therapy for the tumor

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 70-100%

Life expectancy

At least 3 months

Hematopoietic

WBC count ≥ 2,000/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin < 1.2 mg/dL

Renal

Creatinine < 1.3 mg/dL

Cardiovascular

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
No other significant cardiac condition that would preclude study participation

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 1 month after study participation
Weight ≤ 130 kg
No peripheral neuropathy ≥ grade 3
No history of allergic reaction attributed to metronidazole
No other uncontrolled illness
No psychiatric illness or social situation that would preclude study compliance
No other medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110032

Locations

United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283

Sponsors and Collaborators

University of Pennsylvania

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Stephen Michael Hahn, MD

University of Pennsylvania

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000423313, UPCC-01304, NCI-5999
Study First Received:	May 3, 2005
Last Updated:	November 22, 2008
ClinicalTrials.gov Identifier:	NCT00110032
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

adult anaplastic astrocytoma
adult anaplastic ependymoma
adult anaplastic oligodendroglioma
adult brain stem glioma
adult central nervous system germ cell tumor
adult choroid plexus tumor
adult craniopharyngioma
adult diffuse astrocytoma
adult ependymoblastoma
adult ependymoma
adult giant cell glioblastoma
adult glioblastoma
adult gliosarcoma
adult medulloblastoma

adult melanocytic lesion
adult meningeal hemangiopericytoma
adult myxopapillary ependymoma
adult oligodendroglioma
adult pilocytic astrocytoma
adult pineoblastoma
adult pineocytoma
adult subependymoma
adult supratentorial primitive neuroectodermal tumor (PNET)
adult mixed glioma
adult grade I meningioma
adult grade II meningioma
adult grade III meningioma

Study placed in the following topic categories:

Choroid Plexus Neoplasms
Glioblastoma
Neuroectodermal Tumors, Primitive
Astrocytoma
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Hemangiopericytoma
Ependymoma
Brain Neoplasms
Neuroectodermal Tumors

Craniopharyngioma
Medulloblastoma
Neuroepithelioma
Oligodendroglioma
Meningioma
Glioma
Fluorides
Choroid Plexus neoplasms
Gliosarcoma
Pinealoma
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009