Theranostic PET for Target Validation and Tumor Detection

NCT07664410 | Recruiting

• 1 other identifier: 24-12235-BO
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Malignancies

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (6)

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

  12 months

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

  12 months

• Change in staging/prognostic groups and impact on clinical management

  12 months

• Inter-reader reproducibility

  12 months

• Detection rates of theranostic PET on a per-patient basis stratified by tumor maker serum level and velocity (if available)

  12 months

Study Arms (1)

Patients with solid malignancies

performing diagnostic PET/CT with a novel theranostic tracer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for theranostic PET for tumor staging or restaging

You may qualify if:

• PET imaging with a theranostic PET tracer scheduled for staging or restaging of tumor types as part of clinical routine
• Age ≥ 18 years

You may not qualify if:

• 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
• Pregnant, lactating, or breast-feeding women

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

University Hospital Essen

Essen, Germany

RECRUITING

Study Officials

• David Kersting, MD PhD

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josephine Enste

CONTACT

+492017232073; josephine.enste@uk-essen.de

Alina Toni Küper, MD

CONTACT

+492017232073; alina.kueper@uk-essen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 24, 2026
• Study Start: September 23, 2025
• Primary Completion (Estimated): September 23, 2035
• Study Completion (Estimated): September 23, 2035
• Last Updated: June 24, 2026

Record last verified: 2026-01

Locations

DE (1)