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

NCT06246838 | Recruiting

• 1 other identifier: GaTcha
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulmonary Embolism; Ventilation Perfusion Mismatch

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Interventions

Ga-68 V/Q PET/CT DIAGNOSTIC_TEST

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

Also known as: Tc-99m V/Q SPECT/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Pregnancy

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMC Utrecht

Utrecht, 3508 GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Arthur J.A.T. Braat, M.D. Ph.D.

CONTACT

+31887558855; a.j.a.t.braat@umcutrecht.nl

Radiology Desk

CONTACT

+31887558855

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. A.J.A.T. Braat

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 7, 2024
• Study Start: March 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

NL (1)