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

NCT06241391 | Not Yet Recruiting

• 1 other identifier: T/IMF/21/22/04
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioma; Astrocytoma; Anaplastic Astrocytoma; Oligodendroglioma; Glioblastoma Multiforme

Keywords

FDG PET-CT; PSMA PET-CT; MRI brain; Glioma

Outcome Measures

Primary Outcomes (1)

• Detection of sensitivity and specificity of 68Ga PSMA-11 PET-CT to diagnose disease recurrence in gliomas

  Detection of sensitivity and specificity of 68Ga PSMA-11 PET-CT to diagnose disease recurrence in gliomas

  3 months

Secondary Outcomes (4)

• Comparison of tumor SUVmax between 68Ga-PSMA and 18F-FDG PET-CT images

  3 months

• Comparison of sensitivity and specificity of Ga-68 PSMA-11 PET-CT with that of CEMRI in diagnosing disease recurrence in gliomas

  3 months

• Correlation between WHO tumor grade in histology and SUVmax of the recurrent lesion on 68Ga- PSMA PET-CT scan

  3 months

• Correlation between PSMA expression in histopathology specimen (using IHC) and SUVmax of recurrent lesion on 68Ga- PSMA PET-CT scan.

  3 months

Study Arms (1)

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

EXPERIMENTAL

Primary objective Detection of sensitivity and specificity of 68Ga PSMA-11 PET-CT to diagnose disease recurrence in gliomas Secondary objectives 1. Comparison of tumor SUVmax between 68Ga-PSMA and 18F-FDG PET-CT images 2. Comparison of sensitivity and specificity of Ga-68 PSMA-11 PET-CT with that of CEMRI in diagnosing disease recurrence in gliomas 3. Correlation between WHO tumor grade in histology and SUVmax of the recurrent lesion on 68Ga- PSMA PET-CT scan 4. Correlation between PSMA expression in histopathology specimen (using IHC) and SUVmax of recurrent lesion on 68Ga- PSMA PET-CT scan. 5. Any adverse events of Ga-68 PSMA-11 will be recorded according to CTCAE

Diagnostic Test: PSMA PET-CT

Interventions

PSMA PET-CT DIAGNOSTIC_TEST

Prostate Specific Membrane Antigen PET-CT

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

All India Institute of Medical Sciences, Bhubaneswar

Bhubaneswar, Odisha, 751019, India

Location

MeSH Terms

Conditions

Glioma; Astrocytoma; Oligodendroglioma; Glioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Dr.Girish Kumar Parida, MD

CONTACT

+91 9968856817; grissh135@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 5, 2024
• Study Start: February 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)