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The theranostic principle is based on the use of radiolabeled compounds which can be applied for diagnostic molecular imaging and targeted delivery of radiation to the tumor. Gastroenterologic tumors (GET), including hepatocellular Carcinoma, Colorectal Carcinoma, Pancreatic Adenocarcinoma, Cholangiocellular Carcinoma, gastroenteropancreatic neuroendocrine neoplasms also express a phenotypic biomarker called prostate-specific membrane antigen (PSMA), thereby rendering it a potential diagnostic (through positron emission tomography (PET) scan imaging) and therapeutic target for radioligand therapy. Aim is to evaluate whether PSMA-directed in-vivo imaging can be also applied to GET patients to determine if i) biopsy-derived tissue of newly diagnosed patients exhibit a PSMA expression profile, ii) PSMA-PET shows upregulated PSMA expression in-vivo, iii) such a molecular imaging approach identifies more disease sites relative to conventional imaging, and iv) if the PSMA PET signal predicts further clinical course and outcome under guideline-compatible treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastroenterologic tumors histologically positive for PSMA | Experimental | Tumor biopsy at baseline to establish diagnosis and to identify PSMA expression in an ex-vivo setting. Patients with ex-vivo PSMA expression receive a multimodal imaging approach: This includes a PSMA-targeted PET/CT (18F-PSMA) at baseline and conventional imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-PSMA PET/CT | Radiation | Patients with metastasized gastroenterologic tumors, that exhibit histological PSMA expression, receive an additional 18F-PSMA PET/CT to routine imaging. |
| Measure | Description | Time Frame |
|---|---|---|
| True positive rate per patient specimen | The probability of GET is given when immunhistochemistry test is positive. | 24 months |
| True positive rate per patient | The probability of GET is given when 18F-PSMA-1007 PET/CT is positive on a per patient basis. | 24 months |
| Number of patients with identified tumor lesion sites | To compare the sites of disease identified on 18F-PSMA-1007 PET/CT in patients with GET to images derived by conventional imaging to evaluate the sensitivity of 18F-PSMA-1007 PET/CT. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ex-vivo PSMA expression | Expression of PSMA per specimen at immunhistochemistry. | 24 months |
| PSMA uptake on 18F-PSMA-1007 PET | Quantified uptake of PSMA per tumor lesion basis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander M Weich, MD | Contact | +4993120140201 | weich_A@ukw.de | |
| Rudolf A Werner, MD | Contact | +4993120135001 | werner_r4@ukw.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Wuerzburg | Recruiting | Würzburg | Bavaria | 97080 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41198240 | Derived | Michalski K, Reiter FP, Kosmala A, Hartrampf PE, Seifert S, Kalogirou C, Kircher S, Bley TA, Geier A, Meining A, Buck AK, Werner RA, Weich A. Diagnostic Performance of [18F]PSMA-1007 PET/CT on Proven PSMA-Positive Hepatocellular Carcinoma: A Prospective Clinical Study. J Nucl Med. 2026 Jan 2;67(1):43-48. doi: 10.2967/jnumed.125.270755. |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| 24 months |
| D005767 |
| Gastrointestinal Diseases |