Pulmonary EmbolismGaTchaNCT06246838
68Ga PET/CT Versus 99mTc SPECT/CT for Lung Perfusion and Ventilation Scintigraphy; a Technical and Practical Feasibility Study
A study testing Ga-68 V/Q PET/CT in people with Pulmonary Embolism and Ventilation Perfusion Mismatch, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Lung perfusion scintigraphy with 99mTc-MAA and ventilation scintigraphy with Technegas (V/Q SPECT/CT) has been the cornerstone for the detection of pulmonary embolisms (PE) for many decades. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Ventilation Perfusion Mismatch
- What is being tested?
- Ga-68 V/Q PET/CT
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2023to Apr 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
- Adult ≥18 years and declared competent
- Provided written informed consent
- Referred to the Nuclear Medicine Department for a conventional V/Q-SPECT/CT
- Indication for conventional V/Q-SPECT/CT includes known or suspected pulmonary embolism
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Radiology Desk contact
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht, 3508 GA
Arthur J.A.T. Braat, M.D. Ph.D., a.j.a.t.braat@umcutrecht.nl
About this study
Lung perfusion scintigraphy with 99mTc-MAA and ventilation scintigraphy with Technegas (V/Q SPECT/CT) has been the cornerstone for the detection of pulmonary embolisms (PE) for many decades. In last two decades after the introduction of pulmonary CTA, general PE detection has shifted towards CTA and V/Q SPECT/CT has become the modality of choice for specific patient populations (iodine contrast allergy, poor kidney function, pregnancy, etc.) or indications (pre-operative risk stratification, chronic embolism detection, pulmonary hypertension). V/Q SPECT/CT acquisition is performed on a gamma camera, but this technique has distinct challenges and/or disadvantages. A potential alternative is the nowadays broadly available. 68Ga as a positron emitter allows PET/CT imaging. Replacing 99mTc with 68Ga in both MAA and aerosol suspension is easy and requires no modifications. However, 68Ga-V/Q with PET/CT will resolve many of the disadvantages of V/Q SPECT/CT. International studies have proven safety and feasibility of replacing 99mTc with 68Ga and preliminary work by international colleagues and our institute have shown validated preparations of the radiopharmaceuticals. However, in our institution, clinical translation is hampered by lack of data on technical acquisition parameters for our scanners. The aim of this small study is to get more insights into technical parameters for image acquisition, logistical feasibility of V/Q PET/CT, and confirm preliminary non-inferiority of this new technique over the current clinical standard (V/Q SPECT/CT).
- Conditions
- Pulmonary Embolism, Ventilation Perfusion Mismatch
- Being tested
- Ga-68 V/Q PET/CT
- Keywords
- Ga-68-MAA, Galligas, Tc-99m-MAA, Technegas, PET/CT, SPECT/CT
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-68 V/Q PET/CTDiagnostic test
Also called Tc-99m V/Q SPECT/CT
Head-to-head comparison of Ga-68 V/Q PET/CT vs Tc-99m V/Q SPECT/CT
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative assessment of V/Q-PET/CT
Qualitative assessment of different image acquisition parameters for V/Q PET/CT, as determined by blinded assessment by experienced nuclear medicine physicians in a 5-point Likert scale of V/Q PET (compared to the clinical reference standard V/Q SPECT).
Measured: Study participation is maximum 1 week.
Quantitative assessment of V/Q PET/CT
Quantitative assessment of different image acquisition parameters for V/Q PET/CT, by comparison semi-quantitative measurements of V/Q PET (e.g. signal-noise ratio's, etc.).
Measured: Study participation is maximum 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Mar 2023
- Primary completionJan 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Braat, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246838
- Sponsor's protocol ID
- GaTcha
- Acronym
- GaTcha
- Status last verified
- Feb 2024
- First submitted
- 12 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga PET/CT Versus 99mTc SPECT/CT for Lung Perfusion and Ventilation Scintigraphy; a Technical and Practical Feasibility Study
- ClinicalTrials.gov ID
- NCT06246838
- Acronym / sponsor ID
- GaTcha / GaTcha
- Conditions
- Pulmonary Embolism, Ventilation Perfusion Mismatch
- Keywords
- Ga-68-MAA, Galligas, Tc-99m-MAA, Technegas, PET/CT, SPECT/CT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 7 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.
Lung perfusion scintigraphy with 99mTc-MAA and ventilation scintigraphy with Technegas (V/Q SPECT/CT) has been the cornerstone for the detection of pulmonary embolisms (PE) for many decades. In last two decades after the introduction of pulmonary CTA, general PE detection has shifted towards CTA and V/Q SPECT/CT has become the modality of choice for specific patient populations (iodine contrast allergy, poor kidney function, pregnancy, etc.) or indications (pre-operative risk stratification, chronic embolism detection, pulmonary hypertension). V/Q SPECT/CT acquisition is performed on a gamma camera, but this technique has distinct challenges and/or disadvantages. A potential alternative is the nowadays broadly available. 68Ga as a positron emitter allows PET/CT imaging. Replacing 99mTc with 68Ga in both MAA and aerosol suspension is easy and requires no modifications. However, 68Ga-V/Q with PET/CT will resolve many of the disadvantages of V/Q SPECT/CT. International studies have proven safety and feasibility of replacing 99mTc with 68Ga and preliminary work by international colleagues and our institute have shown validated preparations of the radiopharmaceuticals. However, in our institution, clinical translation is hampered by lack of data on technical acquisition parameters for our scanners. The aim of this small study is to get more insights into technical parameters for image acquisition, logistical feasibility of V/Q PET/CT, and confirm preliminary non-inferiority of this new technique over the current clinical standard (V/Q SPECT/CT).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- 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 (4 listed)
- Adult ≥18 years and declared competent
- Provided written informed consent
- Referred to the Nuclear Medicine Department for a conventional V/Q-SPECT/CT
- Indication for conventional V/Q-SPECT/CT includes known or suspected pulmonary embolism
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| Ga-68 V/Q PET/CTAlso: Tc-99m V/Q SPECT/CTHead-to-head comparison of Ga-68 V/Q PET/CT vs Tc-99m V/Q SPECT/CT | Diagnostic test | – |
Primary outcome
Qualitative assessment of V/Q-PET/CT
Time frame: Study participation is maximum 1 week.
Qualitative assessment of different image acquisition parameters for V/Q PET/CT, as determined by blinded assessment by experienced nuclear medicine physicians in a 5-point Likert scale of V/Q PET (compared to the clinical reference standard V/Q SPECT).
Quantitative assessment of V/Q PET/CT
Time frame: Study participation is maximum 1 week.
Quantitative assessment of different image acquisition parameters for V/Q PET/CT, by comparison semi-quantitative measurements of V/Q PET (e.g. signal-noise ratio's, etc.).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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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.
Radiology Desk contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ga-68 V/Q PET/CT in people with Pulmonary Embolism and Ventilation Perfusion Mismatch, run by UMC Utrecht at 1 site in Netherlands.
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 4 inclusion and 1 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 9 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 Netherlands. 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 Arthur J.A.T. Braat, M.D. Ph.D. (+31887558855, a.j.a.t.braat@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative assessment of V/Q-PET/CT (time frame: Study participation is maximum 1 week.). The study lists 2 primary outcomes in all. 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 9 Feb 2024.