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

Pulmonary Embolism Clinical Trial

— GaTcha  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246838
• Other study ID #: GaTcha
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: April 2025

Study information

• Verified date: February 2024
• Source: UMC Utrecht
• Contact: Arthur J.A.T. Braat, M.D. Ph.D.
• Phone: +31887558855
• Email: a.j.a.t.braat[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Ventilation Perfusion Mismatch

Intervention

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

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Study participation is maximum 1 week.
Primary	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.).	Study participation is maximum 1 week.