GliomaNCT06241391
Ga-68 Prostate Specific Membrane Antigen PET/CT in Gliomas
A study testing PSMA PET-CT in people with Glioma and Astrocytoma, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Astrocytoma, Anaplastic Astrocytoma
- What is being tested?
- PSMA PET-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences, Bhubaneswar
Bhubaneswar, Odisha, 751019
Dr Girish Kumar Parida, MD, +91 9968856817, grissh135@gmail.com
About this study
Official title: Role of Ga-68 Prostate Specific Membrane Antigen PET/CT in Detection of Recurrence in Patients With Gliomas
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.
Read the detailed description
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.
- Being tested
- PSMA PET-CT
- Keywords
- FDG PET-CT, PSMA PET-CT, MRI brain, Glioma
- Medical subject headings
- Glioma, Astrocytoma, Oligodendroglioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PET-CTDiagnostic test
Prostate Specific Membrane Antigen PET-CT
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: PSMA PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (4)
Comparison of tumor SUVmax between 68Ga-PSMA and 18F-FDG PET-CT images
Comparison of tumor SUVmax between 68Ga-PSMA and 18F-FDG PET-CT images
Measured: 3 months
Comparison of sensitivity and specificity of Ga-68 PSMA-11 PET-CT with that of CEMRI in diagnosing disease recurrence in gliomas
Comparison of sensitivity and specificity of Ga-68 PSMA-11 PET-CT with that of CEMRI in diagnosing disease recurrence in gliomas
Measured: 3 months
Correlation between WHO tumor grade in histology and SUVmax of the recurrent lesion on 68Ga- PSMA PET-CT scan
Correlation between WHO tumor grade in histology and SUVmax of the recurrent lesion on 68Ga- PSMA PET-CT scan
Measured: 3 months
Correlation between PSMA expression in histopathology specimen (using IHC) and SUVmax of recurrent lesion on 68Ga- PSMA PET-CT scan.
Correlation between PSMA expression in histopathology specimen (using IHC) and
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Girish Kumar Parida, All India Institute of Medical Sciences, Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241391
- Sponsor's protocol ID
- T/IMF/21/22/04
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data will be shared after obtaining permission from the institute post completion of the study
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ga-68 Prostate Specific Membrane Antigen PET/CT in Detection of Recurrence in Patients With Gliomas
- ClinicalTrials.gov ID
- NCT06241391
- Acronym / sponsor ID
- T/IMF/21/22/04
- Keywords
- FDG PET-CT, PSMA PET-CT, MRI brain, Glioma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Efficiency of 68 Ga-PSMA-11 PET-CT in detection of recurrent gliomas | Experimental | Diagnostic Test: PSMA PET-CTPrimary 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSMA PET-CTProstate Specific Membrane Antigen PET-CT | Diagnostic test | Efficiency of 68 Ga-PSMA-11 PET-CT in detection of recurrent gliomas |
Primary outcome
Detection of sensitivity and specificity of 68Ga PSMA-11 PET-CT to diagnose disease recurrence in gliomas
Time frame: 3 months
Detection of sensitivity and specificity of 68Ga PSMA-11 PET-CT to diagnose disease recurrence in gliomas
4 secondary outcomes
Comparison of tumor SUVmax between 68Ga-PSMA and 18F-FDG PET-CT images
Time frame: 3 months
Comparison of sensitivity and specificity of Ga-68 PSMA-11 PET-CT with that of CEMRI in diagnosing disease recurrence in gliomas
Time frame: 3 months
Correlation between WHO tumor grade in histology and SUVmax of the recurrent lesion on 68Ga- PSMA PET-CT scan
Time frame: 3 months
Correlation between PSMA expression in histopathology specimen (using IHC) and SUVmax of recurrent lesion on 68Ga- PSMA PET-CT scan.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No. IPD data will be shared after obtaining permission from the institute post completion of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSMA PET-CT in people with Glioma and Astrocytoma, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr.Girish Kumar Parida, MD (+91 9968856817, grissh135@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of sensitivity and specificity of 68Ga PSMA-11 PET-CT to diagnose disease recurrence in gliomas (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.