Glioma (Diagnosis)Phase 2NCT02971319
Technical Performance Assessment of Tc-99m Tetrofosmin for Differentiation of Recurrence vs Radiation Necrosis in Patients With Glioma
A Phase 2 study testing Tc-99M-Tetrofosmin SPECT and F-18 FDG PET in people with Glioma (Diagnosis), run by Proactina S.A. at 9 sites in 2 countries.
Trial summary
This study aims to assess the technical performance of Tc-99m tetrofosmin SPECT as compared to F-18 FDG PET for the differentiation of radiation necrosis from glioma relapse and to obtain estimates of diagnostic accuracy for Tc-99m tetrofosmin SPECT and F-18 FDG PET in an intra-individual comparison. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma (Diagnosis)
- What is being tested?
- Tc-99M-Tetrofosmin SPECT and F-18 FDG PET
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Sep 2016to 17 Dec 2017
- Phase
- Phase 2
- 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
- confirmed high grade glioma (e.g., anaplastic astrocytoma, glioblastoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma)
- being in follow-up for at least 3 months after completion of radiation therapy (with or without concurrent chemotherapy)
- inconclusive MRI results regarding the differentiation between recurrence and radiation necrosis
- willing and able to undergo all study procedures
- informed consent in writing (dated and signed)
Who cannot join
- age: less than18 years
- if female, pregnant or breast feeding (females of child-bearing potential must use adequate contraception and must have a negative pregnancy test performed within 7 days prior to inclusion into this study)
- contraindications for Tc-99m tetrofosmin
- contraindications for F-18 FDG
- close affiliation with the investigational site; e.g. first-degree relative of the investigator
- participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
Show all 10Show fewer
- having been previously enrolled in this clinical trial
- being mentally disabled
- mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
- Being clinically unstable or requiring emergency treatment
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Hungary8 sites
Országos Klinikai Idegtudományi Intézet (OKITI)
Budapest
Országos Onkológiai Intézet
Budapest
Pozitron-Diagnosztika Ltd.
Budapest
Scanomed Budapest
Budapest
Uzsoki Utcai Kórház
Budapest
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
Debrecen
Scanomed Debrecen
Debrecen
Pécsi Tudományegyetem, Általános
Pécs
About this study
Official title: Exploratory Phase II Study in Patients After Treatment of High Grade Brain Tumors to Assess the Technical Performance of Tc-99m Tetrofosmin for Differentiation of Recurrence Versus Radiation Necrosis
This study aims to assess the technical performance of Tc-99m tetrofosmin SPECT as compared to F-18 FDG PET for the differentiation of radiation necrosis from glioma relapse and to obtain estimates of diagnostic accuracy for Tc-99m tetrofosmin SPECT and F-18 FDG PET in an intra-individual comparison.
- Conditions
- Glioma (Diagnosis)
- Being tested
- Tc-99M-Tetrofosmin SPECT, F-18 FDG PET
- Medical subject headings
- Glioma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc-99M-Tetrofosmin SPECTDevice
F-18 FDG PETDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical performance of Tc-99m tetrofosmin SPECT
Measured: assessed once within 3 weeks of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startSep 2016
- Primary completion17 Nov 2017
- Study completion17 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma (Diagnosis)Studies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proactina S.A.
- Sponsor type
- University, hospital or other
- Collaborators
- ConsulTech GmbH, pharmtrace, Pharmathen S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971319
- Sponsor's protocol ID
- Gliomark
- Status last verified
- Jan 2018
- First submitted
- 16 Nov 2016
- Last updated
- 26 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Phase II Study in Patients After Treatment of High Grade Brain Tumors to Assess the Technical Performance of Tc-99m Tetrofosmin for Differentiation of Recurrence Versus Radiation Necrosis
- ClinicalTrials.gov ID
- NCT02971319
- Acronym / sponsor ID
- Gliomark
- Conditions
- Glioma (Diagnosis)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Proactina S.A.University, hospital or other
- Collaborators
- ConsulTech GmbH, pharmtrace, Pharmathen S.A.
- Study start
- Sep 2016
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 17 Dec 2017 (actual)
- First posted
- 22 Nov 2016 (estimated)
- 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 aims to assess the technical performance of Tc-99m tetrofosmin SPECT as compared to F-18 FDG PET for the differentiation of radiation necrosis from glioma relapse and to obtain estimates of diagnostic accuracy for Tc-99m tetrofosmin SPECT and F-18 FDG PET in an intra-individual comparison.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- confirmed high grade glioma (e.g., anaplastic astrocytoma, glioblastoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma)
- being in follow-up for at least 3 months after completion of radiation therapy (with or without concurrent chemotherapy)
- inconclusive MRI results regarding the differentiation between recurrence and radiation necrosis
- willing and able to undergo all study procedures
- informed consent in writing (dated and signed)
Key exclusion criteria (10 listed)
- age: less than18 years
- if female, pregnant or breast feeding (females of child-bearing potential must use adequate contraception and must have a negative pregnancy test performed within 7 days prior to inclusion into this study)
- contraindications for Tc-99m tetrofosmin
- contraindications for F-18 FDG
- close affiliation with the investigational site; e.g. first-degree relative of the investigator
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 |
|---|---|---|
| Tc-99M-Tetrofosmin SPECT | Device | – |
| F-18 FDG PET | Device | – |
Primary outcome
Technical performance of Tc-99m tetrofosmin SPECT
Time frame: assessed once within 3 weeks of inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tc-99M-Tetrofosmin SPECT and F-18 FDG PET in people with Glioma (Diagnosis), run by Proactina S.A. at 9 sites in 2 countries.
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 10 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: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Hungary, 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical performance of Tc-99m tetrofosmin SPECT (time frame: assessed once within 3 weeks of inclusion). 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 26 Jan 2018.