Imaging Techniques for Brain Tumor

Overseen By Eileen Chang

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Pregnant, breastfeeding, claustrophobia

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new imaging techniques to better understand the behavior of aggressive brain tumors, specifically High Grade Glioma (HGG). Researchers use two types of PET scans, 18F-FLT PET and 18F-FMISO PET, to determine if tumors lack oxygen or are growing rapidly, which can make them harder to treat. The goal is to find better treatment methods for these challenging tumors. Individuals newly diagnosed with suspected HGG based on symptoms and MRI results might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking advancements in brain tumor treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these imaging techniques are safe for studying brain tumors?

In a previous study, researchers used a special scan called 18F-FLT PET with patients who have high-grade glioma, a type of brain tumor. This scan proved helpful for monitoring tumor growth. Generally, 18F-FLT PET is easy for patients to handle, and these studies reported no major side effects.

Another scan, 18F-FMISO PET, has been used in several studies to assess oxygen levels in tumors. Although detailed safety information is limited, researchers have commonly used 18F-FMISO PET in people, and the available research has found no significant safety issues.

Both imaging techniques primarily provide clearer pictures of the tumor, helping doctors understand more about its behavior and growth. While direct safety data is limited, these scans have been used in many research settings without major problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the imaging techniques using 18F-FLT PET and 18F-FMISO PET for high-grade glioma because they offer a more precise way of understanding tumor behavior compared to traditional MRI scans. Unlike standard imaging, which primarily shows the structure of the brain, these PET scans provide insights into the tumor's aggressiveness and oxygen levels. This can help doctors tailor treatments more effectively and potentially improve outcomes for patients with high-grade gliomas.

What evidence suggests that these imaging techniques are effective for assessing High Grade Glioma?

Research has shown that 18F-FLT PET imaging effectively identifies optimal biopsy sites in suspected brain tumor cases. It also outperforms other imaging methods in predicting patient survival and tumor recurrence. In this trial, participants will undergo imaging with either 18F-FLT PET or 18F-FMISO PET. The 18F-FMISO PET effectively highlights low-oxygen areas in brain tumors, which are more challenging to treat. Together, these imaging techniques offer valuable insights into tumor aggressiveness and assist in guiding treatment plans. ^{1 3 6 7 8}

Who Is on the Research Team?

Sadek Nehmeh, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults over 18 suspected to have High-Grade Glioma (HGG) based on clinical assessments and MRI results. It's not suitable for pregnant or breastfeeding individuals, or those who can't undergo PET scans due to conditions like claustrophobia.

Inclusion Criteria

My diagnosis of a high-grade glioma is based on clinical exams and MRI results.

Exclusion Criteria

Pregnant or breastfeeding

You have a condition that makes it unsafe for you to have a PET scan, like claustrophobia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Simultaneous imaging of tumor hypoxia and proliferation using FMISO and FLT PET techniques

1-2 weeks

1-2 visits (in-person)

Surgical Planning and Sampling

Intraoperative neuro-navigation and targeted sampling of FMISO and FLT avid tumor subregions prior to tumor excision

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and surgical procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 18F-FLT PET
• 18F-FMISO PET

Trial Overview The study tests two PET imaging techniques: FMISO PET, which checks if tumor cells are lacking oxygen, and FLT PET, which examines cell growth. These will be compared with tissue biomarkers of hypoxia and proliferation to improve cancer treatment strategies.

How Is the Trial Designed?

Group I: High Grade Glioma (HGG) Experimental Treatment 2 Interventions

Thirty newly diagnosed treatment-naïve subjects with suspected HGG based on clinical presentation and MRI findings and undergoing surgical planning will be accrued in this study.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

William Rhodes Center for Glioblastoma

Collaborator

Trials

1

Recruited

30+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5517561/

18F-fluorothymidine PET imaging in gliomas: an update - PMC F-FLT imaging has been reported to depict accurately the biopsy site when glioma is suspected [24]. The sensitivity of the method in detecting high-grade ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/58/3/393

Repeatability of 18F-FLT PET in a Multicenter Study of ... Methods: 18F-FLT PET was performed on 10 patients with recurrent high-grade glioma at 5 different institutions within the Adult Brain Tumor ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6208814/

Serial FLT PET imaging to discriminate between true ... Moreover, FLT PET has been found to perform better in predicting survival and recurrence in glioma patients than FDG PET and MRI [17, 18]. However, to date, no ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0959804915011260

A systematic review on [18F]FLT-PET uptake as a measure ... This systematic review focuses on the use of [ 18 F]FLT-PET tumour uptake values as a measure of tumour response to therapeutic interventions.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00850278?term=AREA%5BBasicSearch%5D(18F-FLT)&rank=7

NCT00850278 | Assessment of [18F]FLT-PET Imaging for ... The primary objective of this study is to assess the efficacy of the radiopharmaceutical 3'-deoxy-3'-[F-18] fluorothymidine, [F-18 ] FLT , a tracor of cell ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00979810

Image-Guided Stereotactic Biopsy of High Grade Gliomas This is a pilot study intended to collect preliminary data on 15 patients diagnosed with untreated high-grade glioma who are scheduled to undergo surgical ...

7. nature.com nature.com/articles/s41598-025-15185-4

Tumor-specific PET tracer imaging and contrast-enhanced ... This method has been shown to provide robust segmentation for 18 F-FLT PET imaging in glioma patients. ... CAR-based therapeutic targets in ...

8. pet.theclinics.com pet.theclinics.com/article/S1556-8598(24)00080-4/abstract

The State-of-the-Art PET Tracers in Glioblastoma and High ... The role of F18-FDG PET in the evaluation of glioblastoma and high-grade gliomas and monitoring treatment response.