GlioblastomasPAraDiGMNCT03903419
Feasibility Study of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT in Glioblastoma's Patients
A study testing Feasibility study for the realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for identification of early recurrence in patients treated with radiotherapy for glioblastoma. in people with Glioblastomas, run by Centre Leon Berard at 2 sites in France.
Trial summary
This study is a non-randomized, prospective, multicentric feasibility study assessing 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT to differentiate early recurrence from post-radiation modifications in patients treated with radiotherapy for glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastomas
- What is being tested?
- Feasibility study for the realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for identification of early recurrence in patients treated with radiotherapy for glioblastoma.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Jan 2019to 16 Aug 2021
- 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
- Age ≥ 18 years.
- Histologically proven glioblastoma.
- Prior treatment with radiation therapy, with or without any concomitant treatment (e.g., chemotherapy).
- MRI evaluation within the end of radiotherapy to 12 months of follow-up after the end of radiotherapy, with a diagnosis of relapse, or post radiation modifications, or doubt between tumor recurrence or radiation-related complications.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-3.
- Covered by a medical insurance.
- Signed informed consent.
Who cannot join
- Pregnancy.
- Breastfeeding.
- Adults who are subject to a protective measure or who are unable to express their consent.
- Patients treated by Avastin within 3 months.
- Patients participating in clinical trials involving isotopic ionizing imaging examinations and/or angiogenic anti-treatment.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Not yet recruiting
Hôpital Pierre WERTHEIMER - HCL
Bron, 69677
François DUCRAY, M.D, +33472661321, francois.ducray@chu-lyon.fr
François DUCRAY, M.D
- Recruiting
Centre Léon Berard
Lyon, 69008
Aurélie MOREAU, M.D, +33478782682, aurelie.moreau@lyon.unicancer.fr
Aurélie MOREAU, M.D
About this study
Official title: Feasibility Study for the Realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for Identification of Early Recurrence in Patients Treated With Radiotherapy for Glioblastoma
This study is a non-randomized, prospective, multicentric feasibility study assessing 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT to differentiate early recurrence from post-radiation modifications in patients treated with radiotherapy for glioblastoma.
Patients with a MRI performed since the end of the radiotherapy until 12 months of follow up after the end of radiotherapy, will be referred for both 68Ga-PSMA and 18F-FDOPA PET-CT, whatever the conclusion of the MRI (post radiation modifications, relapse or doubtful MRI).
The rationale of doing 68Ga-PSMA and 18F-FDOPA brain PET-CT in each case will be discussed in detail with the referring physician and an informed consent will be taken from each patient for the study. The two imaging studies will be done at least with a gap of 6 hours, using the same PET-CT scanner.
Read the detailed description
Gliomas are the most common primary intra-axial brain tumors arising from the glial cells. The reference treatment consists in a surgical removal followed by radiotherapy and chemotherapy (Temozolomide).
Because of frequent recurrences after first-line therapy, an accurate neuroimaging is needed. The reference anatomical modality is represented by Magnetic Resonance Imaging (MRI), especially multimodal MRI (MRI with gadolinium injection associated with spectroscopy, perfusion and diffusion). One of the particular goals of this imaging is to discriminate recurrences after therapy from radiation-related complications, which can be challenging. These last ones are side effects which turn out after radiotherapy, particularly when high doses are delivered or if chemotherapy is associated. It can occur during the first 3 months after radiotherapy as a subacute radiation related side effects and is then denominated "pseudo-progression", or after the first 3 months of completing radiotherapy as a later and chronic inflammation radiation-related complication named radiation necrosis. It can display clinical symptoms and imaging features which can mimic a relapse. Biopsy is the gold standard but may be not feasible or inconclusive due to limited and non-representative sampling.
The functional nuclear imaging usually completes the anatomical imaging in the oncological response assessment, by providing further metabolic information. Many Positron Emission Tomography (PET) tracers have been studied such as 18F-FDG exploring glucose metabolism, 18F-FLT as a nucleoside analogue, and 18F-FDOPA, 18F-FET, 11C-MET which are radiolabeled amino acids.
A new promising PET radio-tracer is currently soaring. This is the Prostate Specific Membrane Antigen (PSMA) radiolabeled with Gallium 68, a positron emitter, readily available because of a "homemade synthesis". The PSMA is a transmembrane glycoprotein over-expressed in prostate adenocarcinomas
A few studies performed glioblastomas functional imaging based on this PSMA over expression. All achieved to display glioblastomas with 68Ga-PSMA PET-scanner. A recent publication performed on five patients compared 68Ga-PSMA and 18F-FDG in the diagnostic value of glioblastomas recurrence detection. 68Ga-PSMA showed better identification of recurrent lesions owing to a higher target to background ratio. However the place of this new promising tracer in the glioblastomas monitoring remains poorly documented.
Moreover, a study reported that 18F-FDOPA was more accurate than 18F-FDG in the diagnosis of brain tumor recurrence.
To the best of our knowledge, there are no findings concerning 68GA-PSMA and 18F-FDOPA comparison in distinguishing glioblastomas recurrence from radiation-related complications.
Because of the cost and availability of 68Ga-PSMA, if its performances were better than or similar to 18F-FDOPA ones, it could tend to replace this last one in the future. Whether it could be a surrogate to the 18F-FDOPA has not been elucidated yet, representing an interesting challenge.
In this study, the investigators will evaluate the feasibility of using 68Ga-PSMA PET-CT to distinguish recurrent glioblastomas from radiation-related complications, and its comparison with 18F-FDOPA. This study will not allow a proper evaluation of the sensitivity and specificity, which will be performed in a next larger research after completion of this preliminary phase.
- Conditions
- Glioblastomas
- Being tested
- Feasibility study for the realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for identification of early recurrence in patients treated with radiotherapy for glioblastoma.
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility study for the realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for identification of early recurrence in patients treated with radiotherapy for glioblastoma.Diagnostic test
This study is a non-randomized, prospective, feasibility study assessing 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT to differentiate early recurrence from post-radiation modifications in patients treated with radiotherapy for glioblastoma.
Patients with a MRI performed since the end of the radiotherapy until 12 months of follow up after the end of radiotherapy, will be referred for both 68Ga-PSMA and 18F-FDOPA PET-CT, whatever the conclusion of the MRI (post radiation modifications, relapse or doubtful MRI).
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT | Experimental | Functional imaging: 68Ga-PSMA and 18F-FDOPA PET-CT Immunohistochemistry of initial chirurgical sample with determination of PSMA expression Receives: Diagnostic Test: Feasibility study for the realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for identification of early recurrence in patients treated with radiotherapy for glioblastoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Maximum Standardized Uptake Values of 68Ga-PSMA and of 18F-FDOPA PET-CT in glioblastomas recurrences and radiation-related complications after radiotherapy.
Maximum Standardized Uptake Values (SUVmax) of both 68Ga-PSMA and 18F-FDOPA.
Measured: 1 week
Comparison of Target to Background Ratio of 68Ga-PSMA and of 18F-FDOPA PET-CT in glioblastomas recurrences and radiation-related complications after radiotherapy.
Target to Background Ratio (TBR) of both 68Ga-PSMA and 18F-DOPA.
Measured: 1 week
Comparison of Target to Background Ratio and Target to Striatum Ratio of 68Ga-PSMA and of 18F-FDOPA PET-CT in glioblastomas recurrences and radiation-related complications after radiotherapy.
Target to Background Ratio (TBR) of 68Ga-PSMA and Target to Striatum Ratio of 18F-DOPA.
Measured: 1 week
Secondary outcomes (6)
Description of the final diagnosis according to clinical and/or MRI follow-up.
Assessement of tumour recurrence or radiation-related complication.
Measured: 3 months
Concordance between 68Ga-PSMA and 18F-FDOPA PET-CT from visual interpretation.
Measure of agreement between the two techniques using Kappa coefficient based on tracer uptake (abnormal: yes/no).
Measured: 1 week
PSMA expression on initial glioblastoma sample by immunohistochemistry (IHC).
PSMA expression by immunohistochemistry (IHC).
Measured: 3 months
Association between PSMA expression and 68Ga-PSMA PET-CT imaging data.
PSMA expression detectable on IHC: yes or not
Measured: 3 months
Association between PSMA expression (IHC) and 68Ga- PSMA PET-CT imaging data. association between PSMA expression and 68Ga-PSMA PET-CT imaging data.
Measurement of PSMA uptake on PET-CT
Measured: 3 months
Assessment of safety will be based mainly on the frequency of adverse events according to the common toxicity criteria (CTCAE v5.0) grade
The assessment of safety will be based mainly on the frequency of adverse events according to the common toxicity criteria (CTCAE v5.0) grade.
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 posted4 Apr 2019
- Study start16 Jan 2019
- Primary completion16 Aug 2021 (estimated)
- Study completion16 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomasStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie MOREAU, M.D, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903419
- Sponsor's protocol ID
- ET18-143
- Acronym
- PAraDiGM
- Status last verified
- Oct 2020
- First submitted
- 28 Mar 2019
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McBriar JD, Shafiian N, Scharf S, Boockvar JA, Wernicke AG. Prostate-Specific Membrane Antigen Use in Glioma Management: Past, Present, and Future. Clin Nucl Med. 2024 Sep 1;49(9):806-816. doi: 10.1097/RLU.0000000000005365. Epub 2024 Jul 1.
PubMed 38968568
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for the Realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for Identification of Early Recurrence in Patients Treated With Radiotherapy for Glioblastoma
- ClinicalTrials.gov ID
- NCT03903419
- Acronym / sponsor ID
- PAraDiGM / ET18-143
- Conditions
- Glioblastomas
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 16 Aug 2021 (estimated)
- Study completion
- 16 Aug 2021 (estimated)
- First posted
- 4 Apr 2019 (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.
This study is a non-randomized, prospective, multicentric feasibility study assessing 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT to differentiate early recurrence from post-radiation modifications in patients treated with radiotherapy for glioblastoma.
Patients with a MRI performed since the end of the radiotherapy until 12 months of follow up after the end of radiotherapy, will be referred for both 68Ga-PSMA and 18F-FDOPA PET-CT, whatever the conclusion of the MRI (post radiation modifications, relapse or doubtful MRI).
The rationale of doing 68Ga-PSMA and 18F-FDOPA brain PET-CT in each case will be discussed in detail with the referring physician and an informed consent will be taken from each patient for the study. The two imaging studies will be done at least with a gap of 6 hours, using the same PET-CT scanner.
Detailed description
Gliomas are the most common primary intra-axial brain tumors arising from the glial cells. The reference treatment consists in a surgical removal followed by radiotherapy and chemotherapy (Temozolomide).
Because of frequent recurrences after first-line therapy, an accurate neuroimaging is needed. The reference anatomical modality is represented by Magnetic Resonance Imaging (MRI), especially multimodal MRI (MRI with gadolinium injection associated with spectroscopy, perfusion and diffusion). One of the particular goals of this imaging is to discriminate recurrences after therapy from radiation-related complications, which can be challenging. These last ones are side effects which turn out after radiotherapy, particularly when high doses are delivered or if chemotherapy is associated. It can occur during the first 3 months after radiotherapy as a subacute radiation related side effects and is then denominated "pseudo-progression", or after the first 3 months of completing radiotherapy as a later and chronic inflammation radiation-related complication named radiation necrosis. It can display clinical symptoms and imaging features which can mimic a relapse. Biopsy is the gold standard but may be not feasible or inconclusive due to limited and non-representative sampling.
The functional nuclear imaging usually completes the anatomical imaging in the oncological response assessment, by providing further metabolic information. Many Positron Emission Tomography (PET) tracers have been studied such as 18F-FDG exploring glucose metabolism, 18F-FLT as a nucleoside analogue, and 18F-FDOPA, 18F-FET, 11C-MET which are radiolabeled amino acids.
A new promising PET radio-tracer is currently soaring. This is the Prostate Specific Membrane Antigen (PSMA) radiolabeled with Gallium 68, a positron emitter, readily available because of a "homemade synthesis". The PSMA is a transmembrane glycoprotein over-expressed in prostate adenocarcinomas
A few studies performed glioblastomas functional imaging based on this PSMA over expression. All achieved to display glioblastomas with 68Ga-PSMA PET-scanner. A recent publication performed on five patients compared 68Ga-PSMA and 18F-FDG in the diagnostic value of glioblastomas recurrence detection. 68Ga-PSMA showed better identification of recurrent lesions owing to a higher target to background ratio. However the place of this new promising tracer in the glioblastomas monitoring remains poorly documented.
Moreover, a study reported that 18F-FDOPA was more accurate than 18F-FDG in the diagnosis of brain tumor recurrence.
To the best of our knowledge, there are no findings concerning 68GA-PSMA and 18F-FDOPA comparison in distinguishing glioblastomas recurrence from radiation-related complications.
Because of the cost and availability of 68Ga-PSMA, if its performances were better than or similar to 18F-FDOPA ones, it could tend to replace this last one in the future. Whether it could be a surrogate to the 18F-FDOPA has not been elucidated yet, representing an interesting challenge.
In this study, the investigators will evaluate the feasibility of using 68Ga-PSMA PET-CT to distinguish recurrent glioblastomas from radiation-related complications, and its comparison with 18F-FDOPA. This study will not allow a proper evaluation of the sensitivity and specificity, which will be performed in a next larger research after completion of this preliminary phase.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT | Experimental | Diagnostic Test: Feasibility study for the realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for identification of early recurrence in patients treated with radiotherapy for glioblastoma.Functional imaging: 68Ga-PSMA and 18F-FDOPA PET-CT Immunohistochemistry of initial chirurgical sample with determination of PSMA expression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years.
- Histologically proven glioblastoma.
- Prior treatment with radiation therapy, with or without any concomitant treatment (e.g., chemotherapy).
- MRI evaluation within the end of radiotherapy to 12 months of follow-up after the end of radiotherapy, with a diagnosis of relapse, or post radiation modifications, or doubt between tumor recurrence or radiation-related complications.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-3.
Key exclusion criteria (5 listed)
- Pregnancy.
- Breastfeeding.
- Adults who are subject to a protective measure or who are unable to express their consent.
- Patients treated by Avastin within 3 months.
- Patients participating in clinical trials involving isotopic ionizing imaging examinations and/or angiogenic anti-treatment.
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 |
|---|---|---|
| Feasibility study for the realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for identification of early recurrence in patients treated with radiotherapy for glioblastoma.This study is a non-randomized, prospective, feasibility study assessing 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT to differentiate early recurrence from post-radiation modifications in patients treated with radiotherapy for glioblastoma. Patients with a MRI performed since the end of the radiotherapy until 12 months of follow up after the end of radiotherapy, will be referred for both 68Ga-PSMA and 18F-FDOPA PET-CT, whatever the conclusion of the MRI (post radiation modifications, relapse or doubtful MRI). | Diagnostic test | 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT |
Primary outcome
Comparison of Maximum Standardized Uptake Values of 68Ga-PSMA and of 18F-FDOPA PET-CT in glioblastomas recurrences and radiation-related complications after radiotherapy.
Time frame: 1 week
Maximum Standardized Uptake Values (SUVmax) of both 68Ga-PSMA and 18F-FDOPA.
Comparison of Target to Background Ratio of 68Ga-PSMA and of 18F-FDOPA PET-CT in glioblastomas recurrences and radiation-related complications after radiotherapy.
Time frame: 1 week
Target to Background Ratio (TBR) of both 68Ga-PSMA and 18F-DOPA.
Comparison of Target to Background Ratio and Target to Striatum Ratio of 68Ga-PSMA and of 18F-FDOPA PET-CT in glioblastomas recurrences and radiation-related complications after radiotherapy.
Time frame: 1 week
Target to Background Ratio (TBR) of 68Ga-PSMA and Target to Striatum Ratio of 18F-DOPA.
6 secondary outcomes
Description of the final diagnosis according to clinical and/or MRI follow-up.
Time frame: 3 months
Concordance between 68Ga-PSMA and 18F-FDOPA PET-CT from visual interpretation.
Time frame: 1 week
PSMA expression on initial glioblastoma sample by immunohistochemistry (IHC).
Time frame: 3 months
Association between PSMA expression and 68Ga-PSMA PET-CT imaging data.
Time frame: 3 months
Association between PSMA expression (IHC) and 68Ga- PSMA PET-CT imaging data. association between PSMA expression and 68Ga-PSMA PET-CT imaging data.
Time frame: 3 months
Assessment of safety will be based mainly on the frequency of adverse events according to the common toxicity criteria (CTCAE v5.0) grade
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 14 Oct 2020.
- Derived from this study: PubMed 38968568McBriar JD, Shafiian N, Scharf S, Boockvar JA, Wernicke AG. Prostate-Specific Membrane Antigen Use in Glioma Management: Past, Present, and Future. Clin Nucl Med. 2024 Sep 1;49(9):806-816. doi: 10.1097/RLU.0000000000005365. Epub 2024 Jul 1.
- Individual participant dataSharing planned: No
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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.
Aurélie MOREAU, M.D principal investigator
Centre Leon Berard
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feasibility study for the realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for identification of early recurrence in patients treated with radiotherapy for glioblastoma. in people with Glioblastomas, run by Centre Leon Berard at 2 sites in France.
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 7 inclusion and 5 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Aurélie MOREAU, M.D (+33478782682, aurelie.moreau@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Maximum Standardized Uptake Values of 68Ga-PSMA and of 18F-FDOPA PET-CT in glioblastomas recurrences and radiation-related complications after radiotherapy. (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03903419, which also lists 1 linked publication.
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 14 Oct 2020.