Phase 1
N=15
[F-18] Fluorothymidine (FLT) Imaging on Patients With Primary Brain Tumors
Cancer · Brain Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00707343 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Area Under the Receiver Operating Curve (ROC AUC) Values for PET Imaging Techniques — 0.98; 0.91; 0.89; 0.82 Probability
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- FLT-PET Imaging (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Receiver Operating Curve (ROC AUC) Values for PET Imaging Techniques |
0.98; 0.91; 0.89; 0.82 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00707343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.