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Measurement of variation in imaging report findings for 68Ga-PSMA-11 PET/CT in patients with prostate cancer: an international study with participation of multiple centers

68Ga-PSMA-11 PET/CT interobserver agreement for prostate cancer assessments: an international multicenter prospective study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13499475
Enrollment
16
Registered
2016-10-27
Start date
2016-11-01
Completion date
Unknown
Last updated
2022-01-17

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

Conditions

Prostate cancer Cancer

Interventions

Anonymized PET/CT images of 50 patients included in the study (one scan per patient) will be electronically submitted to more than ten nuclear medicine physicians/radiologists from Europe, Asia, Austr
0.0–0.20, slight
0.21–0.40, fair
0.41–0.60, moderate
0.61–0.80, substantial
0.81–1.00, almost-perfect reproducibility. Discrepancies in quantitative ratings among observers will be expressed as mean difference (?) ± standard deviation (SD). Sensitivity, specificity, positive

Sponsors

Department of Nuclear Medicine, Ludwig-Maximilians-University Munich
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Nuclear medicine physician or radiologist with PET/CT experience.

Exclusion criteria

Exclusion criteria: Physicians with prior knowledge of the included patient datasets.

Design outcomes

Primary

MeasureTime frame
Interreader agreement, i.e. the variance between imaging findings of different readers, calculated by Cohen's ?.

Secondary

MeasureTime frame
1. Accuracy for each observer compared to the reference standard, determined by sensitivity, specificity, positive predicive value, and negative predictive value 2. Comparison of accuracy between readers of low and high levels of experience, by difference in pooled sensitivity, specificity, positive predictive value, and negative predictive value

Countries

Australia, Austria, Denmark, France, Germany, Japan, United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026