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Prospective establishment and validation of data-based PET correction methods (motion and attenuation correction) and positronium lifetime at LAFOV PET/CT for children and adults

Prospective establishment and validation of data-based PET correction methods (motion and attenuation correction) and positronium lifetime at LAFOV PET/CT for children and adults - PET data acquisition

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038966
Enrollment
340
Registered
2026-01-15
Start date
2026-03-04
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Patients (male, female, diverse), adults, and children who require a PET/CT scan for justified clinical reasons. There may be various clinical indications for PET/CT scans, and various radiotracers may be used.

Interventions

Group 1: A clinically indicated standard PET/CT scan is performed first and serves as a control. Group 2: First, the clinically indicated standard PET/CT scan is performed (fixed sequence
see arm 1), which serves as a control. Then, in the same patient, additional PET data aquisition are performed after the routine measurements ('arm 2'
this is an intra-individual comparison). For study purposes, PET data acquisition (scan time) is extended by up to 30 minutes in adults and up to 15 minutes in children following the routine PET/CT me

Sponsors

Universitätsklinikum Tübingen, Radiologie, Nuklearmedizin & Klinische Molekulare Bildgebung
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Months to No maximum

Inclusion criteria

Inclusion criteria: •Age 3 months and older (the planned number of cases is n=40 for children and n=300 for adults), •Justifiable clinical indication for a PET/CT examination, •Tolerance of prolonged lying time in the PET/CT scanner, •Written consent of the patient or legal guardian (if developmentally appropriate, consent of the child).

Exclusion criteria

Exclusion criteria: •Pregnant or breastfeeding women, •Claustrophobia or other contraindications for prolonged lying in the scanner, e.g., pain when lying down, •In case of necessary sedation/anesthesia: contraindications for the study-related prolongation of anesthesia, •Limited capacity of the patient or legal guardian to give consent.

Design outcomes

Primary

MeasureTime frame
The availability of data-based, valid attenuation and motion correction methods for adults and children of different ages on the Biograph Vision Quadra, as well as a method for quantifying positronium lifetime, is established. The required measurement parameters, e.g. data-based and sensor-based motion correction, are collected and evaluated for each participant as part of their clinically indicated PET/CT examination (see secondary endpoints). The data will be summarised and evaluated after complete recruitment.

Secondary

MeasureTime frame
Motion correction: Confirmation of the equivalence of the singles events-based and data-driven respiratory curve compared to the sensor-based respiratory curve (respiratory belt) through correlation analysis of the time-synchronized respiratory signals, comparative analysis of the respiratory curves for anomalies, confirmation of equivalence with regard to PET quantification (SUVmean, SUVmax, SUVpeak, MTV, dose values for tumor lesions). Positronium lifetime: Determination of optimal acquisition and reconstruction parameters for oPs lifetime measurement (energy window, acquisition duration, matrix size, fit function, noise behavior, etc.). Attenuation correction: Comparison of data-driven attenuation correction methods with CT-based attenuation correction (SUVmean, SUVmax, SUVpeak, MTV, difference image analysis, NAC, no attenuation correction) and voxel-wise difference image analysis).

Countries

Germany

Contacts

Public ContactChristian la Fougère

Universitätsklinikum Tübingen, Radiologie, Nuklearmedizin & Klinische Molekulare Bildgebung

christian.lafougere@med.uni-tuebingen.de+49 7071- 29-86553

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026