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Genital Diseases

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fludeoxyglucose F 18

fluorine F 18 EF5

Lilie Lin, MD

RATIONALE: Diagnostic procedures, such as fluorine F 18 EF5 PET/CT imaging, may help find oxygen in tumor cells. It may also help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This trial is studying fluorine F 18 EF5 PET/CT imaging to see how well it works in finding hypoxia in tumor cells of patients with locally advanced or recurrent/metastatic cervical cancer.

OBJECTIVES:

* To determine if the presence and heterogeneity of hypoxia can be detected by fluorine F 18 EF5 binding in tumors during PET/CT imaging in patients with newly diagnosed or recurrent carcinoma of the cervix.
* To determine if fludeoxyglucose F 18 uptake correlates with fluorine F 18 EF5 uptake.
* To assess the relationship between fluorine F 18 EF5 uptake and disease-free and overall survival.

OUTLINE: Patients are stratified according to disease stage (locally advanced vs recurrent or metastatic disease).

Patients receive fluorine F 18 EF5 IV followed by PET/CT imaging from the base of skull to upper thigh at baseline and during radiotherapy or chemotherapy (i.e., at 3-4 weeks after the initiation of radiotherapy or after the 4th, 5th, or 6th course of chemotherapy). Patients also undergo fludeoxyglucose F 18 PET/CT imaging within 7 to 10 days of the second fluorine F 18 EF5 scan.

After completion of study treatment, patients are followed up at 30 days and then annually thereafter.

Fluorine F 18 EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Cervical Cancer

[F18]EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Carcinoma of the Cervix

The study was terminated and no data are available to be reported

National Cancer Institute (NCI)

Abramson Cancer Center at Penn Medicine

All Subjects

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The study was terminated and despite all possible attempts to contact the PI/study team, no data are available to be reported

Relationship Between Fluorine F 18 EF5 Uptake and Disease-free Survival and Overall Survival

Overall Study

Nervous System Diseases

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Glioma

Glioblastoma

Brain Neoplasms

Astrocytoma

Meningioma

Oligodendroglioma

Medulloblastoma

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Pinealoma

Ependymoma

Craniopharyngioma

Adamantinoma

Gliosarcoma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Solitary Fibrous Tumors

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Nevus

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Neoplasms, Nerve Tissue

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Nervous System Neoplasms

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Germ Cells Tumors

Pineocytoma

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Neuroepithelioma

Diffuse Astrocytoma

Supratentorial Primitive Neuroectodermal Tumor

Pineoblastoma

Pilocytic Astrocytoma

Anaplastic Ependymoma

Embryonal Tumor With Multilayered Rosettes

Subependymoma

Myxopapillary Ependymoma

Soft Tissue Sarcoma

Ewing Sarcoma

Patients receive fluorine F 18 EF5 (\^18F-EF5) IV followed by whole brain and whole body PET scanning OR whole body PET scanning only. Patients then receive nonradioactive EF5 IV over 1-2 ½ hours.

Patients receive nonradioactive EF5 IV over 1-2½ hours followed by \^18F-EF5 IV. Patients then undergo whole brain and whole body PET scanning.

Patients receive nonradioactive EF5 and \^18F-EF5 as in group 2. Patients then undergo whole brain PET scanning.

conventional surgery

positron emission tomography

pharmacological study

Stephen Michael Hahn

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

PRIMARY OBJECTIVES:

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

Secondary I. Determine the pharmacokinetics and biodistribution of \^18F-EF5 administered before and after nonradioactive EF5 in these patients.

II. Determine the ability of positron emission tomography (PET) scanning using \^18F-EF5 to detect tumor hypoxia in these patients.

III. Determine the presence and pattern of nonradioactive EF5 binding by immunohistochemistry (IHC) and/or flow cytometry in these patients.

IV. 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.

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

Microenvironment: Imaging/Implications in Brain Tumors; A Preliminary Investigation of the Biodistribution of [F-18]-EF5 in Patients With Brain Tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fluorine F 18 EF5 PET/CT Imaging in Patients With Locally Advanced or Recurrent/Metastatic Cervical Cancer	NCT00978874	Cervical Cancer	fludeoxyglucose... fluorine F 18 E...	18 Years - 120 Years	Abramson Cancer Center at Penn Medicine
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	NCT00110032	Adult Anaplasti... Adult Anaplasti... Adult Anaplasti... Adult Brain Ste... Adult Central N... Adult Choroid P... Adult Craniopha... Adult Diffuse A... Adult Ependymob... Adult Ependymom... Adult Giant Cel... Adult Glioblast... Adult Gliosarco... Adult Grade I M... Adult Grade II ... Adult Grade III... Adult Medullobl... Adult Meningeal... Adult Mixed Gli... Adult Myxopapil... Adult Oligodend... Adult Pilocytic... Adult Pineoblas... Adult Pineocyto... Adult Subependy... Adult Supratent... Meningeal Melan...	EF5 conventional su... positron emissi... fluorine F 18 E... pharmacological...	18 Years -	National Cancer Institute (NCI)

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