[F-18] Fluorothymidine (FLT) Imaging on Patients With Primary Brain Tumors
Condition: Cancer; Brain Tumors
MeSH terms: Brain Neoplasms
Intervention: FLT-PET Imaging
Intervention description: 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 patients with glial neoplasms.
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Despite significant advances in the understanding of brain tumor biology and genetics as well
      as improvements in surgical techniques, radiotherapy administration, and chemotherapy
      methods, many primary brain tumors remain incurable. Most primary brain tumors are highly
      infiltrative neoplasms, and are therefore unlikely to be cured by local treatments such as
      surgery, focal radiotherapy, radiosurgery or brachytherapy. A particularly problematic aspect
      of the management of patients with brain tumors is the eventual development of enhancing
      lesions on MRI after radiation therapy. The treating physician is then left with the dilemma
      of what this enhancing lesion may represent (radiation necrosis versus recurrent tumor). The
      differential diagnosis is between recurrent tumor or radiation necrosis however the amount of
      each contributing to the enhancing mass on MRI is difficult if not impossible to assess. This
      particular problem is very common and most patients develop some degree of radiation necrosis
      after therapy with radiation. Differentiation of necrosis from recurrence is particularly
      challenging. MRI is typically unable to make this important distinction as there is simply an
      enhancing mass, the etiology of which could be either necrosis or recurrence. Other imaging
      methods such as FDG-PET have been used but this technique is also complicated in that the
      normal brain has FDG uptake and it is often difficult to differentiate recurrence from
      necrosis. [F-18]FLT may prove to be the most reliable method in making this important
      differentiation (necrosis versus recurrence) as normal brain and necrotic brain do not have
      proliferative activity and thus no [F-18]FLT uptake whereas tumor will have proliferative
      activity and thus [F-18]FLT uptake.
    

Eligibility criteria:

        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.