FDG PET/CT Scan for Glioblastoma

Overseen By Soosan Roodbari

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Severe psychiatric illness, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 48 hours

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special scan, called FDG PET/CT, can quickly show how well early treatment works for people with glioblastoma, a type of brain cancer. The scan uses Fludeoxyglucose F-18 to measure changes in the tumor's sugar use, indicating its response to chemotherapy. Participants must have a confirmed diagnosis of high-grade glioma and plans to start treatment. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance early treatment assessment for future patients.

Do 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.

What prior data suggests that FDG PET/CT is safe for monitoring glioblastoma therapy response?

Research has shown that fludeoxyglucose F-18, used in PET/CT scans, is generally safe for adults. Doctors have used this imaging agent for almost 30 years to observe how tumors metabolize sugar, indicating cancer activity. Although researchers have not fully studied the safety of fludeoxyglucose F-18 in children with cancer or heart issues, adults tolerate it well. Side effects are rare and may include mild issues like dizziness or a rash. Overall, it is considered a safe tool for diagnosing and monitoring brain tumors such as glioblastoma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using FDG PET/CT scans for glioblastoma because this imaging technique can offer a more precise understanding of how the tumor is metabolizing glucose. Unlike standard MRI or CT scans that primarily show the structure of the brain, FDG PET/CT provides insight into the tumor's activity by highlighting areas with increased glucose uptake, which is a hallmark of cancer cells. This could potentially allow doctors to tailor chemotherapy treatments more effectively, ensuring they target the most active parts of the tumor. The timing of the scans, both before and shortly after starting chemotherapy, might also help in quickly assessing how well the treatment is working.

What evidence suggests that FDG PET/CT is effective for monitoring early therapy response in glioblastoma?

Research has shown that FDG PET scans can help distinguish between a returning brain tumor and damage from radiation treatment. This is crucial for patients with glioblastoma, a serious type of brain cancer. In this trial, participants will undergo FDG PET/CT scans to assess these changes. Studies have found that FDG PET scans can clearly show how much sugar the tumor is using. This is important because cancer cells often consume more sugar than normal cells. By examining changes in sugar use, doctors can evaluate how well a treatment is working. Measuring these changes soon after starting chemotherapy provides an early indication of the treatment's effectiveness. ^{4 6 7 8 9}

Who Is on the Research Team?

Johannes Czernin, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 plan to begin treatment.

I have been diagnosed with a high-grade brain tumor.

Exclusion Criteria

Inability to give written consent

Severe psychiatric illness

Breast feeding/pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6-8 weeks

1 visit (in-person)

Treatment

Patients undergo chemotherapy and FDG PET/CT scans to monitor very early therapy response

48 hours

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fludeoxyglucose F-18

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (FDG PET/CT) Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

In a study of six glioma patients undergoing chemotherapy, positron emission tomography (PET) scans showed a significant increase in glucose metabolism in tumors 24 hours after treatment, indicating an acute metabolic response to chemotherapy.

The changes in glucose uptake suggest that the tumors may be utilizing glucose differently post-treatment, potentially for processes like nucleoside synthesis, but by 28 days, metabolic rates varied widely, indicating a complex response to therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucose uptake by gliomas after treatment. A positron emission tomographic study. Rozental, JM., Levine, RL., Nickles, RJ., et al.[2019]

In a case study of a 13-year-old boy with a brain tumor, FDG PET scans showed significant hypermetabolism, indicating a high level of tumor activity, despite other imaging techniques showing uncharacteristic results.

The tumor was ultimately diagnosed as a low-grade ganglioglioma (WHO grade 1), which typically has a good prognosis, highlighting the importance of considering mixed neuronal-glial tumors in young patients when interpreting hypermetabolic PET scan results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High F-18 FDG uptake in a low-grade supratentorial ganglioma: a positron emission tomography case report. Meyer, PT., Spetzger, U., Mueller, HD., et al.[2019]

In a study of 31 patients with adult supratentorial gliomas, FDG PET scans were shown to be a useful tool for assessing tumor progression and treatment response, with higher FDG PET scores correlating with worse clinical outcomes and lower survival rates.

The study involved 137 FDG PET scans and highlighted the need for further research to compare the effectiveness of FDG PET with traditional imaging methods like MRI and CT in managing malignant gliomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of FDG-PET interpretation with survival in a cohort of glioma patients. Pardo, FS., Aronen, HJ., Fitzek, M., et al.[2016]

The novel tracer 18F-fluciclovine (anti-[18F]FACBC) demonstrated a 100% positive predictive value for detecting gliomas in areas not visible on standard contrast-enhanced MRI, indicating its high diagnostic accuracy.

The tracer was well tolerated among patients, with only 17.5% experiencing mild adverse events, none of which were serious, suggesting it is a safe option for glioma imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Wakabayashi, T., Iuchi, T., Tsuyuguchi, N., et al.[2023]

Hybrid PET/MR imaging provides a groundbreaking approach for assessing gliomas, the most common primary brain tumors, by allowing simultaneous evaluation of various brain parameters noninvasively.

Molecular information from PET imaging, particularly using 18F-fluorodeoxyglucose (FDG) and other non-FDG radiotracers, enhances the detection, classification, and treatment planning for gliomas, improving clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Molecular Imaging with PET/MR Imaging in the Diagnosis and Management of Brain Tumors. Borja, AJ., Saini, J., Raynor, WY., et al.[2022]

[18F]FDG remains the most widely used radiotracer for PET studies in brain tumors, providing significant prognostic value and aiding in treatment decisions despite its lower sensitivity for low-grade lesions.

The combination of PET with CT is expected to enhance the sensitivity and specificity of [18F]FDG, particularly in differentiating between tumor relapse and necrosis, although further research is needed to fully understand its advantages over other imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-FDG-PET/CT. Chierichetti, F., Pizzolato, G.[2016]

The combination of MR and PET imaging techniques, particularly using amino acid tracers like (18)F-fluoroethyltyrosine, enhances the ability to accurately identify and delineate aggressive tumor areas in glioblastoma multiforme (GBM), which is crucial for effective treatment planning.

Simultaneous PET-MR imaging not only improves the quantification of PET signals but also reduces overall imaging time, making it more suitable for patients with GBM who are often in critical condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[PET-MR in patients with glioblastoma multiforme]. Ertl-Wagner, B., Ingrisch, M., Niyazi, M., et al.[2021]

FDG-PET is particularly valuable in distinguishing between radiation necrosis and recurrent tumors in glioma patients, with this application accounting for 87% of its use in the study of 75 patients.

While FDG-PET is utilized in various clinical settings for managing primary brain tumors, its primary role is in assessing tumor malignancy and evaluating treatment effects, complementing other imaging techniques like MRI and CT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of fluorodeoxyglucose positron emission tomography on the clinical management of patients with glioma. Deshmukh, A., Scott, JA., Palmer, EL., et al.[2019]

In a study involving 45 patients with suspected glioma, 18F-fluciclovine PET/CT demonstrated a high positive predictive value of 88.0% for identifying tumor areas that were not visible on traditional imaging, aiding in surgical planning.

The use of 18F-fluciclovine PET/CT led to modifications in the planned extent of tumor resection in nearly half of the cases, indicating its potential to improve surgical outcomes for glioma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining the extent of tumor resection at surgical planning with 18F-fluciclovine PET/CT in patients with suspected glioma: multicenter phase III trials. Wakabayashi, T., Hirose, Y., Miyake, K., et al.[2022]

FDG PET is effective in detecting high-grade gliomas, cerebral lymphomas, and some unexpected brain metastases, despite challenges due to high background glucose uptake in the brain.

Methionine-(11C) PET and fluorine (18F)-labeled radiopharmaceuticals like FET and FDOPA provide more accurate delineation of low-grade gliomas and improve the precision of targeting brain cancers during treatments like stereotactic radiosurgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[PET and malignant cerebral tumors]. Talbot, JN., Kerrou, K., Gault, N., et al.[2019]

The combination of FDG-PET/CT and gadolinium-enhanced MRI significantly improves the identification of high-grade gliomas compared to using either imaging method alone, achieving a specificity and positive predictive value of 100% when both tests agree.

However, FDG-PET/CT alone has limited sensitivity (59%) and negative predictive value (55%), indicating that a negative result should not be the sole basis for deciding against surgery in suspected high-grade glioma cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of 18F-fluorodeoxyglucose positron emission tomography in the evaluation of glioma. Shaw, TB., Jeffree, RL., Thomas, P., et al.[2020]

PET/CT imaging using 18F fluorodeoxyglucose (FDG) is a powerful noninvasive tool for diagnosing and assessing treatment responses in various cancers, with over 10,000 scans conducted in a 5-year period at the study center.

Understanding the normal patterns of FDG uptake in the brain is crucial for accurately interpreting scans, as brain cells primarily use glucose, which can affect the detection of both benign and malignant abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spectrum Of Brain Abnormalities Detected On Whole Body F-18 FDG PET/CT Scan. Hassan, A., Majeed, Y., Aftab, K.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3525078/

Comparison of F-18 Fluorodeoxyglucose and F ... Both quantitative and visual determinations allow accurate differentiation between recurrent glioma and radiation necrosis by both FDG and FLT PET.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301605023801

[F-18]-fluorodeoxyglucose positron emission tomography ... Results: The estimated 1-year and 2-year overall survival (OS) for the entire group was 70% and 17%, respectively, with a median overall survival of 70 weeks.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8635110/

Delayed FDG PET Provides Superior Glioblastoma ... Our results revealed statistically significant improvements in the maximum standardized uptake values and subjective conspicuity of glioblastomas at later time ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03732352

NCT03732352 | 18F-FDG PET and Osimertinib in ... This phase II trial studies how well fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET) and osimertinib works in evaluating glucose utilization ...

5. academic.oup.com academic.oup.com/neuro-oncology/article/18/3/426/2509210

Performance of 18F-FET versus 18F-FDG-PET for the ... For brain tumor diagnosis, FET-PET performed much better than FDG and should be preferred when assessing a new isolated brain tumor. For glioma ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3613621/

Role of 18F-fluorodeoxyglucose Positron Emission ... F-18-FDG PET evaluates the lesions on the basis of glucose metabolic activity and has been successfully applied for brain tumor imaging in a wide variety of ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02902757

NCT02902757 | FDG PET/CT in Monitoring Very Early ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... To assess very early response to therapy in glioblastoma patients using 18F-FDG PET/CT.

8. ajronline.org ajronline.org/doi/10.2214/AJR.07.2660

18F-FDG PET of Common Enhancing Malignant Brain Tumors FDG PET may be useful for differentiating common enhancing malignant brain tumors, particularly lymphoma versus high-grade glioma and metastatic tumor.

9. mayoclinic.org mayoclinic.org/drugs-supplements/fludeoxyglucose-f-18-intravenous-route/description/drg-20074508

Fludeoxyglucose f 18 (intravenous route) - Side effects & ... However, safety and efficacy of fludeoxyglucose F 18 injection have not been established in children with cancer or heart disease. Geriatric. No ...