Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo Group
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This pilot clinical trial studies fluordeoxyglucose (fludeoxyglucose) F-18 (FDG) positron emission tomography (PET)/computed tomography (CT) in monitoring very early therapy response in patients with glioblastoma. Diagnostic procedures, such as FDG PET/CT, may help measure a patient's response to earlier treatment. Chemotherapy can induce very rapid changes to the tumor's glucose consumption which can be measured with imaging. FDG PET/CT shortly after the start of therapy may help identify very early therapy response in patients with glioblastoma.
What data supports the effectiveness of the treatment Fludeoxyglucose F-18, 18F-FDG, Fludeoxyglucose F-18, FDG for glioblastoma?
FDG-PET scans, which use Fludeoxyglucose F-18, are helpful in managing brain tumors like glioblastoma by showing how the tumor uses glucose, which can help doctors make treatment decisions. They are particularly useful for distinguishing between tumor regrowth and tissue damage from radiation, and for monitoring how well a treatment is working.
12456Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
Is the FDG PET/CT scan safe for humans?
FDG PET/CT scans, which use a tracer called Fludeoxyglucose F-18, are generally considered safe for humans and are commonly used in medical imaging to assess brain tumors and other conditions.
137911How does the FDG PET/CT scan treatment for glioblastoma differ from other treatments?
The FDG PET/CT scan is unique because it combines imaging techniques to noninvasively assess the metabolic activity of brain tumors, helping to identify the most aggressive parts of glioblastoma. This approach allows for more precise treatment planning compared to traditional methods, which may not provide as detailed a view of tumor metabolism and activity.
3781012Eligibility Criteria
This trial is for patients with high-grade glioma, specifically glioblastoma, who are about to start therapy. They must be able to provide written consent and not have severe psychiatric illnesses. Pregnant or breastfeeding individuals cannot participate.Inclusion Criteria
I have been diagnosed with a high-grade brain tumor.
Participant Groups
The study is testing the use of FDG PET/CT scans in detecting early responses to treatment in glioblastoma patients. It aims to see if changes in tumor glucose consumption after starting chemotherapy can indicate how well the treatment is working.
1Treatment groups
Experimental Treatment
Group I: Treatment (FDG PET/CT)Experimental Treatment3 Interventions
Patients undergo standard FDG PET/CT scan 6-8 weeks before start of chemotherapy and one additional FDG PET/CT scan within 48 hours of the start of chemotherapy.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, CA
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Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
National Institutes of Health (NIH)Collaborator
References
Glucose uptake by gliomas after treatment. A positron emission tomographic study. [2019]Positron emission tomographic scanning with fludeoxyglucose F 18 (18F-fluorodeoxyglucose) was used to study acute changes in gliomas after chemotherapy. In six experimental subjects, scans were obtained before and at days 1, 7, and 30 after treatment. Five control patients with gliomas who did not undergo chemotherapy had two scans, 1 month apart. Ratios were calculated between peak tumor regional cerebral metabolic rate for glucose and contralateral white matter. The percent change in ratios relative to each patient's baseline scan was calculated. Ratios in three stable controls remained unchanged over the study interval; in two controls it increased 155% and 36% and both died of tumor progression. In experimental subjects, ratios increased 20% to 100% 24 hours after chemotherapy and then decreased until at 28 days they varied between 22% above and 35% below baseline. The increased fludeoxyglucose F 18 uptake at 24 hours could be from uncoupling oxidative phosphorylation or shunting glucose to ribose phosphates for salvage nucleoside synthesis.
Impact of fluorodeoxyglucose positron emission tomography on the clinical management of patients with glioma. [2019]The past decade has seen the identification of many clinical settings in the treatment of primary brain tumors in which information from fluorodeoxyglucose positron emission tomography (FDG-PET) might be useful, if not essential, to therapeutic formulation. FDG-PET is currently used at referral centers in the management of primary brain tumors. The clinical pattern of FDG-PET use was assessed and its value compared to other information sources in clinical decision making. The clinical records of 75 glioma patients who were evaluated by FDG-PET were reviewed. The range of circumstances in which FDG-PET was employed included: pretherapeutic baseline studies for monitoring the effect of a therapy (1% of all cases), mapping of hypermetabolic regions before surgery or biopsy (2%), mapping of hypermetabolic regions before radiotherapy (2%), postsurgical evaluation for residual tumor (2%), assessment of the malignancy of a mass as a substitute for biopsy (11%), and distinguishing between radiation necrosis and recurrent tumor (87%). Other sources of information that contributed to the therapeutic management of patients included: gadolinium-enhanced MRI, contrast-CT, and clinical findings.
High F-18 FDG uptake in a low-grade supratentorial ganglioma: a positron emission tomography case report. [2019]Positron emission tomography (PET) with fluorine-18 fluorodeoxyglucose (F-18 FDG) is used for the noninvasive monitoring and grading of primary brain tumors. Here the FDG uptake is positively correlated with the malignant extent of the lesion and thereby negatively correlated with patient survival. Little is known about the FDG PET features of primary brain tumors in children, such as mixed neuronal-glial tumors.
Correlation of FDG-PET interpretation with survival in a cohort of glioma patients. [2016]Adult supratentorial gliomas continue to be one of the most challenging diagnostic and therapeutic problems for the neuro-oncologist. Despite a variety of therapeutic approaches, local control and survival rates remain disappointingly low, largely due to a relative inability to localize diffusely infiltrating glial tumor cells. FDG PET provides a relatively noninvasive method for studying glucose metabolism in normal and pathologic brain tissues. In order to assess the usefulness of FDG PET in a prospective cohort of patients, a group of 31 glial tumor patients underwent serial FDG PET scans at specified evaluation time points: initial or perioperative scan; scan following completion of radiation or chemotherapy; scan(s) at 3-month follow-up intervals until last follow-up exam or death. FDG PET score categories were established to provide a visual and clinically useful means for assessing tumor progression and response to treatment. Both progression-free and overall actuarial survival were determined. There were a total of 137 scans interpreted, on a semi-quantitative basis, by two board-certified radiologists. Patients with high FDG PET scores were more likely to progress clinically and demonstrated lower overall actuarial survival times and revealed statistically significant correlations with other determinants of survival (p
[PET and malignant cerebral tumors]. [2019]Normal biodistribution of FDG includes intense physiologic uptake in the brain, which consumes glucose. The high background therefore makes it difficult to detect the foci taking up glucose, which correspond to malignant lesions. FDG PET is nevertheless clinically useful for detecting high-grade gliomas, cerebral lymphomas and, in some cases, unexpected brain metastases in whole-body PET examinations. As an adjunct to CT and MRI, FDG-PET can make stereotactic radiosurgery more precise in targeting primary or secondary brain cancers and can differentiate necrotic fibrosis from viable cancer tissue during follow-up in cases of abnormal or equivocal MRI results. When available, methionine-(11C) PET delineates low grade gliomas accurately. Several fluorine (18F)-labeled radiopharmaceuticals have been proposed in this setting, with FET and FDOPA apparently the most effective. Four original clinical cases illustrating performances of FET and FDOPA PET in this setting are presented.
18F-FDG-PET/CT. [2016][18F]FDG has been the first radiopharmaceutical used for human brain PET studies and still is the most used radiotracer worldwide for PET and PET/CT oncologic applications. In the assessment of brain tumors, in spite of its low sensitivity in some histological exams, chiefly low-grade lesions, its prognostic value remains of high clinical impact. Moreover, the reliability of [18F]FDG in examining not only the tumor itself, but also the functional state of the whole brain, makes this tracer a valuable tool for treatment decisions and patient management, even nowadays when new tracers (especially amino-acids) are available. In addition, [18F]FDG has a role in the differential diagnosis between relapse and necrosis when assessing aggressive tumors and to establish dedifferentiation in low-grade lesions. With the growing of available therapies, another emerging application of [18F]FDG is the monitoring of response to treatment, even though more evidence is needed to assess the best scanning time. Finally, the implementation of CT in PET devices most likely will improve the sensitivity and specificity of [18F]FDG, even though more data are needed to better understand which is the real advantage of PET/CT with respect to multimodality imaging. Currently, the possible added value of PET/CT is in the study of secondary brain lesions. It is believable that in the future we will keep on speaking about this "old" radiotracer, still alive.
[PET-MR in patients with glioblastoma multiforme]. [2021]Glioblastoma multiforme (GBM) is the most common and most aggressive primary tumor of the brain. In recent years newer therapeutic approaches have been developed. To allow for an optimized treatment planning it is important to precisely delineate necrotic tissue, edema and vital tumor tissue and to identify the most aggressive parts of the GBM. The magnetic resonance (MR) portion of an MR-positron emission tomography (PET) examination in patients with GBM should consist of both structural and functional sequences including diffusion-weighted and perfusion sequences. The use of (18)F-fluorodeoxyglucose ((18)F-FDG) is limited in patients with gliomas as glucose metabolism is already physiologically high in parts of the brain but (18)F-FDG is nevertheless a commonly used radiopharmaceutical for neuro-oncological questions. (18)F-fluorothymidine reflects the cellular activity of thymidine kinase 1 and correlates with the expression of KI-67 as an index of mitotic activity. The nitroimidazole derivatives (18)F-fluoromisonidazole and (18)F-fluoroazomycin arabinoside ((18)F-FAZA) allow the detection of hypoxic areas within the tumor. In recent years amino acid tracers, such as (18)F-fluoroethyltyrosine are increasingly being used in the diagnosis of gliomas. The simultaneous PET-MR image acquisition allows new approaches, e.g. motion correction by the simultaneous acquisition of MR data with a high temporal resolution and an improved quantification of the PET signal by integrating the results of functional MR sequences. Moreover, the simultaneous acquisition of these two time-consuming methods leads to reduced imaging times for this, often severely ill patient group.
Spectrum Of Brain Abnormalities Detected On Whole Body F-18 FDG PET/CT Scan. [2019]Positron emission tomography (PET) with integrated computed tomography (CT) is a unique modality to noninvasively scan the whole body for diagnosing, staging and assessing response to therapy in various benign and malignant diseases. 18F fluorodeoxyglucose (FDG) is the most commonly used radiotracer for PET/CT imaging in cancer patients. FDG is a glucose analogue which is the predominant substrate for brain metabolism. As the brain cells are obligate glucose consumers, the knowledge of physiologic radiotracer uptake within the brain is imperative for correct interpretation of abnormal sites of metabolism. Over 10,000 PET/CT scans have been performed at our centre in a 5 years' period. A spectrum of brain abnormalities, both benign and malignant, detected in cancer patients undergoing whole body 18F FDG PET/CT imaging has been compiled.
Diagnostic Performance and Safety of Positron Emission Tomography Using 18F-Fluciclovine in Patients with Clinically Suspected High- or Low-grade Gliomas: A Multicenter Phase IIb Trial. [2023]Label="OBJECTIVES" NlmCategory="OBJECTIVE">The study objective was to assess the diagnostic performance of positron emission tomography (PET) for gliomas using the novel tracer 18F-fluciclovine (anti-[18F]FACBC) and to evaluate the safety of this tracer in patients with clinically suspected gliomas.
Diagnostic performance of 18F-fluorodeoxyglucose positron emission tomography in the evaluation of glioma. [2020]Identifying glioma grade through imaging allows clinicians to recommend and accurately direct treatment. We sought to quantify the utility of FDG-PET/CT (18F-fluorodeoxyglucose positron emission tomography/computed tomography), alone and in combination with MRI, in identifying high-grade regions of glioma.
Determining the extent of tumor resection at surgical planning with 18F-fluciclovine PET/CT in patients with suspected glioma: multicenter phase III trials. [2022]Label="OBJECTIVE" NlmCategory="OBJECTIVE">Glioma is the most common type of central nervous system tumor reported worldwide. Current imaging technologies have limitations in the diagnosis and assessment of glioma. The present study aimed to confirm the diagnostic efficacy and safety of anti-1-amino-3-[18F]fluorocyclobutane carboxylic acid (18F-fluciclovine; anti-[18F]FACBC) as a radiotracer for patients undergoing combined positron emission tomography and computed tomography (PET/CT) for suspected glioma.
Role of Molecular Imaging with PET/MR Imaging in the Diagnosis and Management of Brain Tumors. [2022]Gliomas are the most common primary brain tumors. Hybrid PET/MR imaging has revolutionized brain tumor imaging, allowing for noninvasive, simultaneous assessment of morphologic, functional, metabolic, and molecular parameters within the brain. Molecular information obtained from PET imaging may aid in the detection, classification, prognostication, and therapeutic decision making for gliomas. 18F-fluorodeoxyglucose (FDG) has been widely used in the setting of brain tumor imaging, and multiple techniques may be employed to optimize this methodology. More recently, a number of non-18F-FDG-PET radiotracers have been applied toward brain tumor imaging and are used in clinical practice.