Investigational Scan for Brain Tumor Recurrence

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Antiangiogenic therapy

Disqualifiers: Pregnancy, Nursing, Contraception, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method to better detect whether a brain tumor, called glioma, has returned or worsened after initial treatment. The study employs a special PET/CT scan with a radioactive substance, Ga-68 PSMA-11 (also known as Gallium Ga-68 gozetotide or Gallium Ga-68 PSMA-11), to reveal tumor activity in the brain. Suitable candidates for this trial have a history of aggressive glioma, have undergone initial treatment, and face possible tumor recurrence, with surgery planned for confirmation. This scan could help avoid unnecessary surgeries by providing clearer insights into tumor activity. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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 this imaging technique is safe for patients with glioma?

Research has shown that Ga-68 PSMA-11 is generally safe. In a study with 960 participants, researchers thoroughly checked its safety. This imaging agent has FDA approval for diagnosing and staging prostate cancer, providing extensive safety information.

However, as with any imaging agent, there is a risk from radiation exposure. Long-term exposure can increase cancer risk. For most people, though, the benefits of obtaining accurate images outweigh the risks. Overall, the treatment is well-tolerated, and serious side effects are rare. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Ga 68 PSMA-11 because it offers a novel way to detect brain tumor recurrence with high precision. Unlike traditional imaging techniques, Ga 68 PSMA-11 is a radiotracer that targets the prostate-specific membrane antigen, which is often overexpressed in certain tumors. This targeted approach allows for more accurate PET/CT scans, potentially leading to earlier detection and better management of recurrent brain tumors. The method is also less invasive and could provide quicker results compared to conventional imaging options, helping doctors make timely and informed decisions about patient care.

What evidence suggests that Ga-68 PSMA-11 PET/CT is effective for detecting brain tumor recurrence?

Research has shown that Ga-68 PSMA-11 PET/CT scans are already used to locate prostate cancer due to their ability to accurately identify cancer cells. This imaging agent adheres to blood vessels in tumors, including those in the brain. It assists doctors in determining whether a tumor is returning, worsening, or if changes result from treatment. Previous studies have demonstrated that this scanning method is promising in precisely identifying cancer locations. In this trial, participants will receive Ga-68 PSMA-11 and undergo PET/CT scans to test its effectiveness for brain tumors, aiming to provide clearer answers without requiring surgery. ^{3 4 5 6 7}

Who Is on the Research Team?

Brian J. Burkett, MD, MPH

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for patients with glioma, a type of brain tumor. It's specifically aimed at those who have undergone treatment and need to determine if their disease has returned or worsened. Participants should be due for an imaging assessment as part of their standard care.

Inclusion Criteria

MRI findings compatible with contrast-enhancing recurrent infiltrating glioma

I am scheduled for surgery to remove a suspected recurring brain tumor.

I am willing to allow my doctors to share my radiation and follow-up records.

Exclusion Criteria

I am of childbearing age and not using birth control.

I am currently breastfeeding.

Unable to undergo a PSMA PET/CT scan (e.g. body habitus, claustrophobia)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Patients receive Ga-68 PSMA-11 intravenously and undergo PET/CT over 1 hour, 50-100 minutes after injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ga 68 PSMA-11

Trial Overview

The study tests Ga-68 PSMA-11 PET/CT scans to see if they're better than current methods at telling the difference between tumors that are growing back or getting worse and changes caused by previous treatments in glioma patients.

How Is the Trial Designed?

Group I: Diagnostic (Ga-68 PSMA-11, PET/CT) Experimental Treatment 4 Interventions

Patients receive Ga-68 PSMA-11 IV and then undergo PET/CT over 1 hour, 50-100 minutes after injection.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A new automated method for producing gallium-68 from zinc-68 targets can generate up to 194 GBq of purified gallium-68, meeting the high clinical demand for this isotope.

The produced gallium-68 compounds, including [68Ga]Ga-PSMA-11 and [68Ga]Ga-DOTATATE, showed excellent radiochemical purity and sufficient shelf-life for clinical applications, ensuring safety and efficacy in medical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-curie production of gallium-68 on a biomedical cyclotron and automated radiolabelling of PSMA-11 and DOTATATE. Thisgaard, H., Kumlin, J., Langkjær, N., et al.[2021]

The study developed a ready-to-use kit for radiolabeling DKFZ-PSMA-11 with Gallium-68, which allows for efficient and specific imaging of prostate cancer using PET/CT.

The (68)Ga-DKFZ-PSMA-11 kit demonstrated high diagnostic performance in detecting primary prostate cancer and its advanced lesions, meeting all quality assurance criteria for human application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Single Vial Kit Solution for Radiolabeling of 68Ga-DKFZ-PSMA-11 and Its Performance in Prostate Cancer Patients. Ebenhan, T., Vorster, M., Marjanovic-Painter, B., et al.[2021]

Ga-PSMA-11 PET/CT is a promising diagnostic tool for detecting recurrent glioblastoma multiforme (GBM), showing high tumor-to-brain ratios and no adverse events related to the radiopharmaceutical in the study of patients with suspected recurrence.

While Ga-PSMA-11 shows potential for targeted therapies due to PSMA expression in recurrent GBM, the low tumor-to-liver ratio indicates that its effectiveness for targeted radionuclide therapy may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-Prostate-Specific Membrane Antigen-11 PET/CT: A New Imaging Option for Recurrent Glioblastoma Multiforme? Kunikowska, J., Kuliński, R., Muylle, K., et al.[2021]

[68Ga]Ga-PSMA-11 is a key radiopharmaceutical used for imaging prostate-specific membrane antigen (PSMA), which is crucial for managing recurrent prostate cancer.

The paper provides a comprehensive overview of the preclinical development and clinical applications of [68Ga]Ga-PSMA-11, comparing its effectiveness with other imaging methods to guide clinicians in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[68Ga]Ga-PSMA-11 in prostate cancer: a comprehensive review. Bois, F., Noirot, C., Dietemann, S., et al.[2020]

The novel 68Ga-THP PSMA PET/CT imaging technique was found to be safe for use in prostate cancer patients, with no serious adverse events reported and only minor side effects observed in two patients.

This imaging method led to a change in clinical management for 42.9% of the patients evaluated, indicating its potential effectiveness in guiding treatment decisions for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase II, Open-label study to assess safety and management change using 68Ga-THP PSMA PET/CT in patients with high risk primary prostate cancer or biochemical recurrence after radical treatment: The PRONOUNCED study. Afaq, A., Payne, H., Davda, R., et al.[2022]

The imaging agent [68Ga]Ga-PSMA-093 shows excellent blood clearance and rapid tumor uptake, making it effective for detecting prostate cancer lesions, as confirmed by clinical studies.

Different sources of 68Ge/68Ga generators can be used to reliably produce [68Ga]Ga-PSMA-093 with high yields, ensuring the availability of this imaging tracer for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kit-based preparation of [68Ga]Ga-P16-093 (PSMA-093) using different commercial 68Ge/68Ga generators. Hong, H., Wang, G., Ploessl, K., et al.[2022]

In a study involving 88 patients with prostate cancer, the Ga-PSMA-11 ligand for PET/CT imaging showed no reported clinical adverse events, indicating a strong safety profile for this imaging agent.

While there were significant decreases in systolic blood pressure and heart rate over time, these changes were minimal and did not lead to any cases of hypotension, confirming that Ga-PSMA-11 is well tolerated in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Safety Evaluation of 68Ga-Labeled Ligand Prostate-Specific Membrane Antigen 11 PET/CT in Prostate Cancer: The Results of 2 Prospective, Multicenter Trials. Nielsen, JB., Zacho, HD., Haberkorn, U., 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]

In a study of 19 prostate cancer patients, 68Ga-PSMA PET/CT imaging successfully identified recurrence in 15 out of 17 patients with biochemical recurrence after radical prostatectomy, demonstrating its effectiveness in early detection of cancer spread.

The imaging technique revealed positive sites of recurrence in both single and multiple locations, leading to salvage lymphadenectomy in four patients, with histological confirmation of malignancy in three cases, highlighting its potential to guide treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnostic performance of 68GA-PSMA PET/CTin patients with prostate cancer]. Veliev, EI., Tomilov, AA., Goncharuk, DA., et al.[2019]

The 68Ga-PSMA-11 PET/CT imaging technique demonstrated a detection rate of 53.6% for identifying prostate cancer relapse in 332 patients, with varying effectiveness based on the clinical stage of biochemical recurrence (BCR).

The positive predictive value (PPV) of 68Ga-PSMA-11 PET/CT was very high at 96.2%, indicating its reliability in detecting local versus systemic disease in patients with rising PSA levels after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-11 PET/CT in recurrent prostate cancer: efficacy in different clinical stages of PSA failure after radical therapy. Ceci, F., Castellucci, P., Graziani, T., et al.[2021]

(68)Ga-PSMA PET/CT is a highly sensitive diagnostic tool for detecting primary prostate cancer and its metastases, outperforming traditional fluorine-18 choline PET/CT by identifying more metastases at lower PSA levels.

The (68)Ga-PSMA radioligand can be produced in hospitals using a gallium generator, making it a convenient and accessible option for prostate cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Not Available]. Lavalaye, J., Lam, MG., Verzijlbergen, JF., et al.[2021]

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]

Citations

1.

trials.braintumor.org

trials.braintumor.org/trials/NCT06444412

An Investigational Scan (Ga-68 PSMA-11 PET/CT) for ...

This study may help researchers learn whether GA-68 PSMA-11 PET/CT is useful for improving detection of tumor recurrence or progression, as opposed to treatment ...

2.

pmc.ncbi.nlm.nih.gov

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

[68Ga]Ga-PSMA-11: The First FDA-Approved 68Ga ...

In the FDA approval, [68Ga]Ga-PSMA-11 is indicated for the initial diagnosis and staging of prostate cancer patients with suspected metastases and the imaging ...

3.

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.

4.

withpower.com

withpower.com/trial/phase-2-who-grade-4-glioma-5-2024-b3123

Investigational Scan for Brain Tumor Recurrence

Ga 68 PSMA-11 has been evaluated in clinical trials for prostate cancer and is generally considered safe, with no serious adverse events reported. Some minor ...

5.

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 ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2020/212643s000lbl.pdf

Gallium Ga 68 PSMA-11 Injection, for intravenous use

Long-term cumulative radiation exposure is associated with an increased risk for cancer. ... The safety of Ga 68 PSMA-11 Injection was evaluated in 960 ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06444412

An Investigational Scan (Ga-68 PSMA-11 PET/CT) for ...

This study may help researchers learn whether GA-68 PSMA-11 PET/CT is useful for improving detection of tumor recurrence or progression, as opposed to treatment ...