About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with newly diagnosed GET prior to initiation of guideline-compatible, anti-tumor therapy
Available tissue specimen to conduct PSMA expression profiling
Male/female, above 18 years old
Patients must provide written informed consent
Disqualifiers
Curative setting
Not sufficient tumor tissue available
Male Patients: No prostate carcinoma
Other malignant neoplasms in patient's history
Trial design
Single group
Treatments tested in this trial
18F-PSMA PET/CT
RadiationPatients with metastasized gastroenterologic tumors, that exhibit histological PSMA expression, receive an additional 18F-PSMA PET/CT to routine imaging.
Treatment groups
Trial outcomes
Primary outcomes
True positive rate per patient specimen
The probability of GET is given when immunhistochemistry test is positive.
True positive rate per patient
The probability of GET is given when 18F-PSMA-1007 PET/CT is positive on a per patient basis.
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.
Secondary outcomes
Ex-vivo PSMA expression
Expression of PSMA per specimen at immunhistochemistry.
PSMA uptake on 18F-PSMA-1007 PET
Quantified uptake of PSMA per tumor lesion basis.
Sponsors and contacts
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