Ga-68 Prostate Specific Membrane Antigen PET/CT in Gliomas

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Ga-68 Prostate Specific Membrane Antigen PET/CT in Gliomas

Study Purpose

As a part of molecular imaging, many PET tracers have been investigated in this regard. Those include 18F-FDG being glucose analogue, 18F-FLT representing nucleoside metabolism, and 18F-FDOPA, 18F-FET, 11C-MET as amino acids analogues. Among these, 18F-FDG is the most commonly used tracer due to its broader use and easy availability. However, high physiological uptake in the brain is a significant limitation. The main limitation of other tracers is the need for onsite cyclotrons for their production, making their availability difficult. So, the search for an ideal modality is still ongoing, and the latest addition to this search is a radio ligand labeled Prostate Specific Membrane Antigen (PSMA). It is a new but potentially promising radiotracer, currently showing its utility in different malignancies. Investigators, therefore, aim to identify whether Ga-68 PSMA PET-CT has better diagnostic accuracy in the detection of recurrent gliomas than conventional imaging modalities.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients with age more than18 years.

- Patients having past history of histologically proven glioma.

- Patients who have undergone prior treatment with tumor resection and/or radiation therapy and/or chemotherapy.

- Clinically suspected cases of recurrence.

- Patient should be willing to and able to give written informed consent.

Exclusion Criteria:

- Pregnant lady.

- Breastfeeding mother.

- Patients who will deny to give consent.

- Any brain primary other than high grade glioma.

- Patient diagnosed with other primary malignancy.

- Patient with life threating neurological emergency

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06241391
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	All India Institute of Medical Sciences, Bhubaneswar
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	India
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, Astrocytoma, Anaplastic Astrocytoma, Oligodendroglioma, Glioblastoma Multiforme

Additional Details

Prostate Specific Membrane Antigen (PSMA is a type II membrane glycoprotein and is typically overexpressed in primary and metastatic lesions of prostate malignancy as the name suggests. However, this overexpression is not limited to prostate cancer only. It has been reported that, PSMA is overtly expressed in the vascular endothelium of various other malignancies where significant neovascularization is seen. Gliomas being highly vascularized tumors, have shown significant PSMA expression in their vascular endothelium especially in high grade ones. If this PSMA expression can be assessed through noninvasive molecular imaging, this would further ease the management these tumors. Different lesions have shown different grades of PSMA uptake in the PET/CT with high grade gliomas showing high uptake. Most of the articles published till date are either case reports or studies comprising very few numbers of patients. We would like to use the PET tracer Ga -68 PSMA for the detection of recurrence in patients with glioma. Investigators believe that 68 Ga PSMA PET-CT has the potential to play an imperative role in noninvasively evaluating recurrent gliomas and can overcome the limitations of the currently used modalities. Besides, extrapolation of the PSMA expression, which is indirect evidence of neovascularization, can also be used to assess treatment options like VEGF inhibitors (Bevacizumab). These studies can also pave the way for further studies involving PSMA-based radio ligand therapy, which is currently being successfully applied in patients with metastatic prostate cancer.

Arms & Interventions

Arms

Experimental: Efficiency of 68 Ga-PSMA-11 PET-CT in detection of recurrent gliomas

Primary objective Detection of sensitivity and specificity of 68Ga PSMA-11 PET-CT to diagnose disease recurrence in gliomas Secondary objectives Comparison of tumor SUVmax between 68Ga-PSMA and 18F-FDG PET-CT images Comparison of sensitivity and specificity of Ga-68 PSMA-11 PET-CT with that of CEMRI in diagnosing disease recurrence in gliomas Correlation between WHO tumor grade in histology and SUVmax of the recurrent lesion on 68Ga- PSMA PET-CT scan Correlation between PSMA expression in histopathology specimen (using IHC) and SUVmax of recurrent lesion on 68Ga- PSMA PET-CT scan. Any adverse events of Ga-68 PSMA-11 will be recorded according to CTCAE

Interventions

Diagnostic Test: - PSMA PET-CT

Prostate Specific Membrane Antigen PET-CT

Contact a Trial Team

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