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Theranostic PET for Target Validation and Tumor Detection

ConditionSolid Malignancies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Essen

About this trial

Patients are referred for theranostic PET using different tracers as part of clinical routine for tumor staging, re-staging, and therapy planning to our department.

The aim of this study is to collect data on the expression of target molecules/receptors, proportion of PET positive tumor regions, positive predictive value, detection rate, reproducibility, and impact on clinical management of theranostic PET/CT or PET/MRI using novel theranostic PET tracers or other established PET tracers that are performed in theranostic concepts on patients receiving this imaging modality as part of clinical standard both at initial diagnosis and restaging before treatment decisions.

Primary Endpoint:

Association between PET uptake intensity in theranostic PET and histopathologic expression of the respective molecular target.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

PET imaging with a theranostic PET tracer scheduled for staging or restaging of tumor types as part of clinical routine

Age ≥ 18 years

Disqualifiers

Patient cannot give consent for the study

Patient cannot lie flat or tolerate PET imaging

Unwillingness or inability to comply with study and follow-up procedures

Condition of patient which is critical to participate in this study in the discretion of the investigators

Trial population

Patients scheduled for theranostic PET for tumor staging or restaging

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 1 trial group
Group A: Patients with solid malignancies

Trial outcomes

Primary outcomes

1

Association between PET uptake intensity in theranostic PET and histopathologic expression of the respective molecular target.

Time frame
12 months

Secondary outcomes

1

Proportion of tumor manifestations with uptake in theranostic PET on a per-lesion, per-region, and per-patient basis

Time frame
12 months
2

Detection rate and PPV of theranostic PET on a per-patient and per-region-basis, confirmed by histopathology, clinical and conventional imaging follow-up

Time frame
12 months
3

Change in staging/prognostic groups and impact on clinical management

Time frame
12 months
4

Inter-reader reproducibility

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Essen

Lead sponsor

Source ClinicalTrials.gov
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