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

NCT ID: NCT06246838

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Pulmonary Embolism Ventilation Perfusion Mismatch

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Ga-68 V/Q PET/CT

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Tc-99m V/Q SPECT/CT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Arthur Braat

Dr. A.J.A.T. Braat

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UMC Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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

Role: CONTACT

+31887558855

Radiology Desk

Role: CONTACT

+31887558855

Facility Contacts

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

Role: primary

Other Identifiers

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GaTcha

Identifier Type: -

Identifier Source: org_study_id

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