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Preliminary Evaluation of the Efficacy of [F-18] Fluorothymidine (FLT) to Differentiate Radiation Necrosis From Tumor Recurrence and as a Marker of Proliferation in Patients With Primary Brain Tumors


N/A
18 Years
N/A
Open (Enrolling)
Both
Cancer, Brain Tumors

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Trial Information

Preliminary Evaluation of the Efficacy of [F-18] Fluorothymidine (FLT) to Differentiate Radiation Necrosis From Tumor Recurrence and as a Marker of Proliferation in Patients With Primary Brain Tumors


The primary objective of this study is to assess the preliminary efficacy of the
radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that
directly assess tumor proliferation using Positron Emission Tomography (PET) in
differentiating tumor recurrence from radiation necrosis in a group of 30 patients with
glial neoplasms. This preliminary clinical study will investigate [F-18]FLT in patients with
previously treated primary malignant brain tumors (WHO Grade II, III or IV glial-based
tumors) who have a new or enlarging enhancing lesion on Gd-MRI and in whom it is not
possible to differentiate recurrent tumor from radiation necrosis on the basis of
conventional imaging techniques. The ability to make this important differentiation and
accurately determine the amount/degree of tumor recurrence from the amount/degree of
radiation necrosis in the enhancing mass is critical for the care of treated brain tumor
patients and could potentially change patient management once validated as an accurate means
of differentiating the amount/degree of radiation necrosis from recurrence.

While the safety of [F-18]FLT has been studied in a many patients to date we will also
obtain additional safety data on the use of this agent in patients with primary brain tumors
in a cohort of the initial 12 patients to be studied. It is important to emphasize that the
potential clinical application of [F-18]FLT imaging in brain tumors must be compared to the
current widely used imaging techniques of MRI and PET imaging using the agent, [F-18]
fluorodeoxyglucose (FDG).

In this study, [F-18]FLT PET will be used to assess the three goals of this project:

1. Show that imaging with [F-18]FLT and PET will or will not better determine the
amount/degree of tumor versus necrosis in the abnormal areas seen on the recent MRI
scan and FDG-PET scan.

2. The [F-18]FLT radiopharmaceutical is shown to be safe or not safe in the amount
administered in this study.

3. The amount of [F-18]FLT that is seen on the PET study is shown to correlate or not to
correlate with other tests used to determine the proliferation of brain tumors in a
tissue sample of your newly identified abnormality on MRI in the event that another
surgical biopsy or procedure is performed


Inclusion Criteria:



- Adult patients (n = 20) with primary brain tumors will be studied.

- All patients will have had previous radiation and may or may not have had
chemotherapy for treatment of the primary brain tumor.

- All patients must have either radiological or established histological diagnosis of
the following general categories: glioma (grade 2 to grade 4) previously treated with
radiation therapy and possibly chemotherapy. It is expected that some of the patients
may need a biopsy or neurosurgical procedure for diagnostic and/or therapeutic
purposes as necessary treatment of their disease. In those instances the pathologic
results will be used for correlation with the imaging findings. Only clinically
indicated biopsy and/or surgery will be done and surgery is incidental to inclusion
in the protocol.

- Patients must be 18 years or older for inclusion in this study.

- After entry into the study, the initial 12 patients are expected to be followed for
at least 1 month after the infusion of [F-18]FLT.

- The patient, if female, must be postmenopausal for a minimum of one year or
surgically sterile, or on one of the following methods of birth control for a minimum
of one month prior to entry into this study: IUD, oral contraceptives, Depo-Provera
or Norplant. These criteria can be waived at the discretion of the investigator if
the patient's intracranial tumor is considered life threatening and the one month
wait required is not in the best interest of the patient. Negative pregnancy test is
accepted.

- Pre-treatment laboratory tests for patients receiving [F-18]FLT must be performed
within 14 days prior to study entry. These must no greater or less than 4X the normal
upper or lower limits. These will include liver enzymes (SGOT, SGPT, ALK Phos, GGT,
LDH), bilirubin (direct and total), amylase, serum electrolytes, CBC with platelets
and absolute neutrophil counts, prothrombin time, partial thromboplastin time, BUN,
creatinine, and urinalysis.

- Pre-treatment radiological scans/studies (Gd- enhanced MRI and FDG-PET) for patients
receiving [F-18]FLT must be performed within 10 days of study entry.

Exclusion Criteria:

- Patients with clinically significant signs of uncal herniation, such as acute
pupillary enlargement, rapidly developing motor changes (over hours), or rapidly
decreasing level of consciousness, are not eligible.

- Patients with known allergic or hypersensitivity reactions to previously administered
radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune
diseases may be enrolled at the Investigator's discretion.

- Patients who are pregnant or lactating or who suspect they might be pregnant.

- Adult patients who require monitored anesthesia for PET scanning.

- HIV positive patients due to the previous toxicity noted with FLT in this patient
group.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Show that imaging with [F-18]FLT and PET will or will not better determine the amount/degree of tumor versus necrosis in the abnormal areas seen on the recent MRI scan and FDG-PET scan

Outcome Time Frame:

December 2011

Safety Issue:

No

Principal Investigator

John M Hoffman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Huntsman Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

HCI20112

NCT ID:

NCT00707343

Start Date:

May 2007

Completion Date:

December 2013

Related Keywords:

  • Cancer
  • Brain Tumors
  • Brain Neoplasms

Name

Location

Huntsman Cancer InstituteSalt Lake City, Utah  84112