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

Trial Summary

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 data supports the effectiveness of the treatment 68Ga-PSMA-11 PET Scans for brain tumors?

The research shows that 68Ga-PSMA-11 PET scans have been used effectively for imaging prostate cancer, and preliminary analysis suggests it may also be feasible for imaging brain tumors. This indicates potential for the treatment to help in identifying brain tumors, although more specific studies are needed to confirm its effectiveness for this use. ^{1 2 3 4 5}

How does the drug used in PET scans for brain tumors differ from other treatments?

The drug used in PET scans for brain tumors, 68Ga-PSMA-11, is unique because it targets prostate-specific membrane antigen (PSMA) expressed in the blood vessels of brain tumors, providing clearer images compared to traditional methods. This allows for better visualization of tumors due to its high tumor-to-background ratio, which is not achieved with standard imaging techniques. ^{2 3 6 7 8}

What is the purpose of this trial?

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 participants with high-grade glioma/HGG or brain metastases.

Research Team

Anton Nosov, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Ga-68 PSMA PET/CT in recurrent high-grade gliomas: evaluating PSMA expression in vivo. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Diagnostic Value of 68Ga PSMA-11 PET/CT Imaging of Brain Tumors-Preliminary Analysis. [2021]

3. United States 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. [2021]

4. England 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. [2022]

5. Switzerland 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

68 Ga-PSMA-11 PET/CT Imaging in Brain Gliomas and Its Correlation With Clinicopathological Prognostic Parameters. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

[99mTc]Tc-iPSMA SPECT brain imaging as a potential specific diagnosis of metastatic brain tumors and high-grade gliomas. [2021]

8. India 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. [2023]