Evaluating the feasibility and accuracy of novel intra-operative molecular imaging with two PSMA-tracers in prostate cancer

Evaluating the feasibility and accuracy of novel intra-operative molecular imaging with two PSMA-tracers in prostate cancer - CLI AI PSMA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00020942

Enrollment

Registered

2020-03-30

Start date

2019-12-13

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C61

Interventions

Group 1: Intraoperative assessment of Cerenkov luminescence using the CLI-System (Lightpoint medical Ltd., U.K.) and autoradiography imaging (AI) respectively by using a flexible scintillator and PSMA

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Male = 18 years of age • Histologically confirmed adenocarcinoma of the prostate • High-risk for positive surgical margins a. cT3 stage according to TNM classification, or b. ISUP Gleason grade group 4/5, or c. PSA >15 ng/ml • Indication for radical prostatectomy • Preoperative PCa staging performed according to current guidelines

Exclusion criteria

Exclusion criteria: • Known hypersensitivity to the diagnostic PET agent or its components • Administration of any kind of PET tracer within a period corresponding to 8 half-lives of the respective radionuclide • Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders) • Evidence of neuroendocrine small cell prostate cancer • Polytope metastases on conventional imaging as per CHAARTED criteria (visceral metastases or =4 bone metastases including at least one outside the axial skeleton)

Design outcomes

Primary

Measure	Time frame
Assessment of positive surgical margins in radical prostatectomy using novel intra-operative molecular imaging (CLI and AI) with PSMA-labeled radiopharmaceuticals (68Ga-PSMA-11 / 18F-PSMA 1007) as compared to final histopathology.	—

Secondary

Measure	Time frame
- Compare performance of CLI±AI to frozen section analysis - Assess positive lymph node status in CLI±AI with final histopathology - Compare both tracers regarding lymph node status - Evaluate the flexible scintillator in reducing background noise - Evaluate the radiation exposure of the surgery and pathology teams - Compare the duration of complete intra-operative imaging vs. frozen section analysis.	—

Measure

Time frame

- Compare performance of CLI±AI to frozen section analysis - Assess positive lymph node status in CLI±AI with final histopathology - Compare both tracers regarding lymph node status - Evaluate the flexible scintillator in reducing background noise - Evaluate the radiation exposure of the surgery and pathology teams - Compare the duration of complete intra-operative imaging vs. frozen section analysis.

—

Countries

Germany

Contacts

Public ContactBoris Hadaschik

Klinik und Poliklinik für Urologie,Kinderurologie und UroonkologieUniversitätsklinikum Essen

boris.hadaschik@uk-essen.de+49 201 723 3210

Outcome results

None listed

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