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68Ga PET/CT Versus 99mTc SPECT/CT for Lung Perfusion and Ventilation Scintigraphy; a Technical and Practical Feasibility Study

68Ga PET/CT Versus 99mTc SPECT/CT for Lung Perfusion and Ventilation Scintigraphy; a Technical and Practical Feasibility Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06246838
Acronym
GaTcha
Enrollment
20
Registered
2024-02-07
Start date
2023-03-01
Completion date
2025-04-30
Last updated
2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism, Ventilation Perfusion Mismatch

Keywords

Ga-68-MAA, Galligas, Tc-99m-MAA, Technegas, PET/CT, SPECT/CT

Brief 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. 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).

Interventions

DIAGNOSTIC_TESTGa-68 V/Q PET/CT

Head-to-head comparison of Ga-68 V/Q PET/CT vs Tc-99m V/Q SPECT/CT

Sponsors

UMC Utrecht
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

\- Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Qualitative assessment of V/Q-PET/CTStudy 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/CTStudy 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.).

Countries

Netherlands

Contacts

Primary ContactArthur J.A.T. Braat, M.D. Ph.D.
a.j.a.t.braat@umcutrecht.nl+31887558855
Backup ContactRadiology Desk
+31887558855

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026