To investigate and define the most optimal technical acquisition parameters for V/Q PET/CT
ID
Source
Brief title
Condition
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Investigate and define optimal image acquisition parameters for V/Q PET/CT.
Within the two patient groups, different technical parameters will be applied
during image acquisition and post-processing. After enrolment of the final
participant (#20) and image acquisition, all imaging studies will be presented
to two independent nuclear medicine physicians, for a blinded assessment,
presented in a random order. During the first assessment round; Independent
physicians should grade subjective image quality according to a five-point
Likert scale (ranging from very poor to very good). During a second assessment
round; Independent physicians should grade image quality, compared to the
current clinical standard (V/Q-SPECT). Finally, in the same round as the second
assessment, physicians should report whether or not additional perfusion and/or
ventilation defects could be acknowledged.
Besides subjective image quality assessment, (semi-)quantitative measurement
will be performed by a medical physicist (e.g. signal-to-noise ratio, etc.)
Secondary outcome
Confirm feasibility of 68Ga-MAA and Galligas (preparation for administration
and administration at the aimed time points). This will be derived from the
radionuclide pharmacy (RNA) log and weekly radiopharmaceutical meetings within
the department.
Confirm logistical advantages of 68Ga-V/Q-PET/CT over 99mTc-V/Q-SPECT/CT.
Differences in total acquisition times will be gathered and compared by a
simple two-sided t-test; total scanning time per separate procedure
(99mTc-MAA/99mTechnegas/68Ga-MAA/68Galligas) and a combination of scans
(V/Q-SPECT/CT vs V/Q-PET/CT). Additionally, total procedure time will be
gathered and compared in a similar fashion. Registration of both acquisition
times and procedure times are standard practice and can be directly derived
from the imaging archive (Sectra PACS) or medical record files (HiX, Chipsoft).
Background 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. Preliminary work by
international colleagues and our institute have shown preparation of the
radiopharmaceuticals are identical, and several international studies have
proven safety and feasibility of replacing 99mTc with 68Ga. 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 objective
To investigate and define the most optimal technical acquisition parameters for
V/Q PET/CT
Study design
Head-to-head, in-patient comparison, open label, observational cohort.
Study burden and risks
Risk of an additional V/Q PET/CT are absent, as previous clinical studies have
shown no additional toxicities/adverse events following 68Galligas and
68Ga-MAA. The only expected risk entails limited additional radiation burden to
the patient, 3-5 mSv (similar to V/Q SPECT/CT, but lower than pulmonary CTA).
The main benefit for future patients with known or suspected PE will be of
logistical nature, in which the entire investigation can be performed in 1 hour
(instead of in two parts on two separate days), without increasing radiation
burden or inducing toxicities. Additionally, for physicians, improved image
quality (due to the intrinsic higher resolution of PET over SPECT) allows
improved detection of PE and, based on the results from the previously
published PECAN study, interobserver variability of subsegmental PE (the most
common indication for V/Q SPECT/CT at the moment) is improved. All together, we
believe the V/Q PET/CT may improve our standard clinical care, once appropriate
technical parameters are defined
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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
- Children or adolescents (<18 years)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83137.041.22 |