PET Scans for Brain Tumors

Recruiting at 12 trial locations

Overseen By Anton Nosov, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pregnancy, Active infection, Heart failure, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

30 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 type of scan, called 68Ga-PSMA-11 PET/CT, can help doctors assess the activity of brain tumors in individuals with high-grade glioma or brain metastases. These scans could provide a clearer picture of the cancer's aggressiveness. Suitable candidates for this trial have been diagnosed with or are suspected to have these specific brain tumors and are planning a biopsy or surgery on their brain lesion. As an Early Phase 1 trial, this research focuses on understanding the scan's function in people, offering participants an opportunity to contribute to groundbreaking medical insights.

Will I have to stop taking my current medications?

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 68Ga-PSMA-11 PET/CT scans are safe for assessing brain tumors?

Research shows that 68Ga-PSMA-11 PET scans are generally safe. In previous studies, this imaging method demonstrated a good safety record with prostate cancer patients, indicating it is usually well-tolerated and rarely causes serious side effects. Another study with brain tumor patients also reported positive immediate safety results.

The FDA has already approved 68Ga-PSMA-11 for certain uses, suggesting it is considered safe when used properly. However, precautions such as wearing special gloves are taken to limit radiation exposure. Overall, past research indicates this treatment appears safe, but ongoing studies will provide more information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard approaches for high-grade glioma, which often involve surgery, radiation, or chemotherapy, 68Ga-PSMA-11 PET scans offer a novel imaging technique that can enhance tumor detection. Researchers are excited about this method because it targets the prostate-specific membrane antigen (PSMA), which is overexpressed in certain brain tumors, providing potentially more precise imaging than conventional scans. This precision could lead to better treatment planning and monitoring, improving outcomes for patients with high-grade glioma or brain metastases.

What evidence suggests that 68Ga-PSMA-11 PET/CT is effective for assessing tumor activity in high-grade glioma or brain metastases?

Research has shown that 68Ga-PSMA-11 PET scans, which participants in this trial will undergo, can reveal the activity level of brain tumors. Other studies have found that this type of scan clearly shows tumor activity, which is crucial for evaluating aggressive brain tumors and cancer that has spread to the brain. One study compared 68Ga-PSMA-11 with another imaging method and found it provided valuable insights into the tumor's behavior. This evidence suggests that 68Ga-PSMA-11 PET scans might be a helpful tool for visualizing brain tumors and could assist in planning treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Anton Nosov, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This clinical trial is open to individuals with high-grade gliomas or brain metastases. Participants must be suitable for PET/CT scans and have a type of brain tumor that might show activity on these scans.

Inclusion Criteria

I have or am suspected to have a high-grade glioma or brain metastases from another cancer.

Ability to understand and the willingness to sign (or their legally acceptable representative (LAR) must sign) a written informed consent document

I am scheduled for a brain surgery to remove or sample a lesion.

Exclusion Criteria

Patients with severe allergy to both iodinated and gadolinium contrast.

I do not have any serious illnesses that would stop me from following the study's requirements.

Pregnant or nursing female. All women of childbearing potential must have a documented negative serum or urine pregnancy test <1 week before study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo 68Ga-PSMA-11 PET/CT scans to assess tumor uptake

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

• 68Ga-PSMA-11 PET Scans

Trial Overview The study is testing the effectiveness of a special imaging scan called 68Ga-PSMA-11 PET/CT in detecting active cancer cells in patients with certain types of aggressive brain tumors or secondary brain cancers.

How Is the Trial Designed?

Group I: Participants with high-grade glioma Experimental Treatment 1 Intervention

Participants with newly diagnosed or recurrent high-grade glioma/HGG or brain metastases

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study of 30 patients with recurrent high-grade gliomas (rHGG), Ga-68 PSMA PET imaging showed increased tracer uptake in all detected lesions, indicating its effectiveness in identifying tumor recurrence.

The study demonstrated a 100% concordance between MRI and PET imaging for detecting lesions, suggesting that Ga-68 PSMA PET could be a reliable tool for evaluating rHGG and has potential for theranostic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ga-68 PSMA PET/CT in recurrent high-grade gliomas: evaluating PSMA expression in vivo. Kumar, A., ArunRaj, ST., Bhullar, K., et al.[2022]

In a study of 24 patients with glioblastoma, Ga-68 PSMA PET-CT imaging demonstrated a strong correlation with MRI for defining tumor volumes, with complete overlap in 17 cases, suggesting it is a reliable tool for treatment planning.

The use of Ga-68 PSMA PET-CT may lead to more accurate delineation of gross tumor volumes, potentially reducing radiation therapy side effects by avoiding unnecessary treatment of non-tumor areas affected by postoperative changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of Target Volumes on Magnetic Resonance Imaging and Prostate-Specific Membrane Antigen Brain Scans in the Treatment Planning of Glioblastomas. Lavanya, V., Malik, IM., Nallapareddy, K., et al.[2023]

Ga PSMA-11 PET/CT imaging demonstrated better visualization of brain lesions, particularly in glioblastoma cases, compared to F-FDG PET/CT, showing a significant improvement in target to background ratios (TBR).

The study suggests that Ga PSMA-11 PET/CT is a promising tool for evaluating brain lesions due to its ability to provide clearer images of metabolically active disease, as it shows minimal physiological uptake in normal brain tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Value of 68Ga PSMA-11 PET/CT Imaging of Brain Tumors-Preliminary Analysis. Sasikumar, A., Joy, A., Pillai, MR., et al.[2021]

The study successfully standardized an automatic synthesis protocol for the radiopharmaceutical [68Ga]Ga-PSMA-11, achieving a high radiochemical purity of 99.06%, which is crucial for effective PET imaging of prostate cancer.

[68Ga]Ga-PSMA-11 demonstrated excellent stability and binding properties, with significant accumulation in prostate tumors and favorable tumor-to-blood ratios, indicating its potential for accurate tumor localization in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardization of the [68Ga]Ga-PSMA-11 Radiolabeling Protocol in an Automatic Synthesis Module: Assessments for PET Imaging of Prostate Cancer. Fuscaldi, LL., Sobral, DV., Durante, ACR., et al.[2021]

In a study of 15 patients with gliomas, the PSMA PET tracer (68 Ga-PSMA-11) showed significantly higher uptake in high-grade gliomas compared to low-grade ones, indicating its potential as a prognostic tool for assessing tumor aggressiveness.

The study suggests that PSMA-targeted therapies could be beneficial for patients with high PSMA uptake in their gliomas, although further research with larger sample sizes is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68 Ga-PSMA-11 PET/CT Imaging in Brain Gliomas and Its Correlation With Clinicopathological Prognostic Parameters. Verma, P., Singh, BK., Sudhan, MD., et al.[2023]

In a study involving 41 patients with suspected brain tumors, [99mTc]Tc-iPSMA SPECT brain imaging demonstrated high specificity (100%) and sensitivity (94%) for diagnosing high-grade gliomas (HGG) and brain metastases (BM), indicating its potential as a reliable diagnostic tool.

The imaging technique showed significantly increased uptake in HGG and BM compared to low-grade gliomas (LGG) and reactive gliosis, correlating well with histopathological findings and PSMA expression in tumor vasculature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[99mTc]Tc-iPSMA SPECT brain imaging as a potential specific diagnosis of metastatic brain tumors and high-grade gliomas. Vallejo-Armenta, P., Soto-Andonaegui, J., Villanueva-Pérez, RM., et al.[2021]

The preparation of [(68)Ga]PSMA-11 for PET-CT imaging in prostate cancer patients resulted in consistently high radiochemical yields of 93.19%±3.76%, with over 200 batches produced and no batch failures reported.

The radiopharmaceutical demonstrated high radiochemical purity (>99%) and was well-tolerated by over 300 patients, with no adverse reactions observed, indicating its safety and efficacy for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation of [(68)Ga]PSMA-11 for PET-CT imaging using a manual synthesis module and organic matrix based (68)Ge/(68)Ga generator. Nanabala, R., Anees, MK., Sasikumar, A., et al.[2021]

The study developed a new, simple, and validated HPLC method to assess the chemical and radiochemical purity of [68Ga]Ga-PSMA-11, which is crucial for ensuring its quality in clinical use.

This method addresses the challenges posed by the short half-life of [68Ga]Ga-PSMA-11 and the variability in synthesis conditions, potentially improving the reliability of PET imaging in prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a UV-Radio-HPLC method to assess chemical and radiochemical purity of [68Ga] Ga-PSMA-11. Pehli Vanoglu, H., Ocak, M., Caglar-Andac, S.[2022]

Citations

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Study Details | NCT03368547 | 68Ga-PSMA-11 PET/CT in ... This clinical trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with intermediate or ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37883060/

68 Ga-PSMA-11 PET/CT Imaging in Brain Gliomas and Its ... The aim of the present study was to correlate and compare the 68 Ga-PSMA-11 and 18 F-FDG uptake in brain tumors with their clinicopathological prognostic ...

3. asco.org asco.org/abstracts-presentations/ABSTRACT366868

[68Ga]Ga-PSMA-11 PET baseline imaging as a prognostic ... Conclusions: Higher SUVmean is strongly associated with improved outcomes with 177Lu-PSMA-617; clinical efficacy for different SUV levels vs the SoC arm is ...

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/451442

A Study of 68Ga-PSMA-11 PET Scans in People With Brain ... The purpose of this study is to find out whether 68Ga-PSMA-11 PET/CT is effective in assessing tumor uptake (tumor activity seen in cancerous tissue) in ...

5. illuccixhcp.com illuccixhcp.com/efficacy/

Clinical Efficacy | Illuccix® (kit for the preparation of gallium Ga ... View the established clinical efficacy for Illuccix® across prostate cancer stages demonstrated in pivotal trials with ⁶⁸Ga-PSMA-11.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8401928/

[68Ga]Ga-PSMA-11: The First FDA-Approved 68Ga ... Comparison of 68Ga-labelled PSMA-11 and 11C-choline in the detection of prostate cancer metastases by PET/CT. Eur. J. Nucl. Med. Mol. Imaging. 2017;44:92 ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/212642s000lbl.pdf

Gallium Ga 68 PSMA-11 Injection, for intravenous use Handle Ga 68 PSMA-11 Injection with appropriate safety measures to minimize radiation exposure [see. Warnings and Precautions (5.2)]. Use waterproof gloves, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06444412

An Investigational Scan (Ga-68 PSMA-11 PET/CT) for ... To assess the feasibility and immediate safety profile of gallium Ga 68 gozetotide (Ga-68 labeled PSMA-11) brain PET in patients with gliomas, assessed as the ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11281955/

Evaluation of 68Ga-PSMA-11 PET/CT: a Phase 1 clinical ... 68 Ga-PSMA-11 has a favourable safety and tolerability profile in Japanese patients with primary, recurrent, or suspected recurrent prostate cancer.

10. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-03913

An Investigational Scan (Ga-68 PSMA-11 PET/CT) for the ... To assess the feasibility and immediate safety profile of gallium Ga 68 gozetotide (Ga-68 labeled PSMA-11) brain PET in patients with gliomas, assessed as ...