Condition category
Cancer
Date applied
13/10/2016
Date assigned
27/10/2016
Last edited
01/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
68Ga-PSMA-11 PET/CT is a new imaging technique developed to use for investigating how advanced a cancer is and where it is located. It can be used, for example, to monitor the response of a cancer to radiotherapy. The overall value of a imaging technique such as this depends on the degree of reader agreement – that is, if a number of people agree on what the image is showing. Knowing how different people will interpret the same image (interobserver variability) and how many people will agree that it shows the same thing (reproducibility) is essential for interpreting the results of studies and for designing new studies. The aim here is to determine interobserver agreement for 68Ga-PSMA-11 PET/CT interpretations for prostate cancer and to compare the findings among highly experienced and less experienced readers.

Who can participate?
Nuclear medicine physicians or radiologists with PET/CT experience.

What does the study involve?
Participants are given 68Ga-PSMA-11 PET/CT images from anonymous patients with prostate cancer and, upon a visual inspection, are asked to report on their findings using a standard template. They are asked to interpret what they see from a number of images of lymph nodes affected by localized prostate cancer and divided into different regions or sections. The participants are asked to judge whether each image they see shows prostate cancer. The results are compared to that of histopathology and follow-up imaging taken for all the patients more than six months before the 68Ga-PSMA-11 PET/CT imaging. Interobserver agreement between participants is assessed.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Department of Nuclear Medicine, Ludwig-Maximilians-University Munich (Germany)

When is the study starting and how long is it expected to run for?
October 2016 to March 2017

Who is funding the study?
Department of Nuclear Medicine, Ludwig-Maximilians-University Munich (Germany)

Who is the main contact?
Dr Wolfgang Fendler

Trial website

Contact information

Type

Scientific

Primary contact

Dr Wolfgang Fendler

ORCID ID

Contact details

Marchioninistraße 15
81377 München
Munich
81377
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13102016.1.0

Study information

Scientific title

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

Acronym

PSMAGREE

Study hypothesis

The overall value of an imaging method is associated with the degree of reader agreement. Knowledge of interobserver variability and reproducibility is therefore essential for interpreting study results and design of future trials. The aim of this study is to determine interobserver agreement for interpretations of 68Ga-PSMA-11 PET/CT and to compare findings among readers with low and high levels of experience.

Ethics approval

Ethics Committee of the Ludwig-Maximilians-University Munich, 10/06/2016, ref: 594-16UE

Study design

Observational

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Prostate cancer

Intervention

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, Australia or North America. Data include standard DICOM files of CT and attenuation-corrected PET images.

All reader report a visual interpretation of the 68Ga-PSMA-11 PET/CT image datasets using a standard template. Visual interpretation will be performed for locoragional lymph nodes - divided into pelvic regions, extra-pelvic lymph nodes, bone and visceral organs. Each region will be judged positive or negative for prostate cancer involvement.

For binary data, agreement among each observer and the reference reader will be evaluated using Cohen's κ. Overall agreement using pooled observer data will be evaluated using generalized estimation equations. For non-binary data, agreement among all observers was evaluated by intraclass correlation coefficient (ICC) using two-way mixed model for absolute agreement (single measures). Ninety-five percent confidence intervals (CIs) are reported for κ and ICC values. Interpretation of κ and ICC will be based on a classification provided by Landis and Koch: 0.0, poor; 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 (Δ) ± standard deviation (SD). Sensitivity, specificity, positive predicive value, and negative predicive value will be calculated for each observer

Histopathology and follow-up (PSA and imaging) obtained for all patients more than six months before the index test serves as reference standard. Lymph nodes regions, organs and bone will be judged positive or negative for prostate cancer involvement based on the results from histopathology and follow-up imaging.

Intervention type

Device

Phase

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

13/10/2016

Overall trial end date

01/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Nuclear medicine physician or radiologist with PET/CT experience.

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

16

Participant exclusion criteria

Physicians with prior knowledge of the included patient datasets.

Recruitment start date

01/11/2016

Recruitment end date

13/12/2016

Locations

Countries of recruitment

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

Trial participating centre

Department of Nuclear Medicine, Ludwig-Maximilians-University Munich
Klinik und Poliklinik für Nuklearmedizin Klinikum der Universität München Marchioninistraße 15 81377 München
Munich
81377
Germany

Trial participating centre

University of California Los Angeles
Ahmanson Biological Imaging Clinic 10833 LeConte Ave.
Los Angeles
CA 90095-6948
United States of America

Trial participating centre

University Hospital Essen
Department of Nuclear Medicine
Essen
-
Germany

Trial participating centre

Hokkaido University Graduate School of Medicine
Department of Nuclear Medicine Kita 15, Nishi 7, Kita-ku
Sapporo
060-8638
Japan

Trial participating centre

Technical University of Munich (TUM)
Department of Nuclear Medicine
Munich
-
Germany

Trial participating centre

University of Ulm
Department of Nuclear Medicine
Ulm
-
Germany

Trial participating centre

Bichat University Hospital
Department of Nuclear Medicine Inserm 698 University Paris 7 46 rue Henri Huchard
Paris
75018
France

Trial participating centre

University of Rostock
Department of Nuclear Medicine
Rostock
18051
Germany

Trial participating centre

St Vincent's Public Hospital Sydney
Department of Nuclear Medicine
Sydney
-
Australia

Trial participating centre

Aalborg University Hospital
Department of Nuclear Medicine Hobrovej 18-22
Aalborg
9000
Denmark

Trial participating centre

University of California San Francisco
Department of Nuclear Medicine 05 Parnassus Ave
San Francisco
CA 94143
United States of America

Trial participating centre

General Hospital of Vienna (AKH)
Department of Nuclear Medicine
Vienna
-
Austria

Trial participating centre

University Hospital of Würzburg
Department of Nuclear Medicine
Würzburg
-
Germany

Sponsor information

Organisation

Department of Nuclear Medicine, Ludwig-Maximilians-University Munich

Sponsor details

Klinik und Poliklinik für Nuklearmedizin
Klinikum der Universität München
Marchioninistraße 15
81377 München
Munich
81377
Germany

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Department of Nuclear Medicine, Ludwig-Maximilians-University Munich

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results (Cohen's κ, intraclass correlation coefficient, sensitivity, specificity, positive predicitive value, negative predictive value, accuracy) will be published within three to six months of completion of the trial.

Intention to publish date

01/03/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/11/2016: Added list of trial participating centres