Gastrointestinal Cancer
Conditions
Brief summary
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.
Interventions
RADIATION18F-PSMA PET/CT
Patients with metastasized gastroenterologic tumors, that exhibit histological PSMA expression, receive an additional 18F-PSMA PET/CT to routine imaging.
Sponsors
Wuerzburg University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Patients must be willing to comply with study procedures and available for follow-up examinations
Exclusion criteria
* Curative setting * Not sufficient tumor tissue available * Male Patients: No prostate carcinoma * Other malignant neoplasms in patient's history * Pregnancy or Breastfeeding * Contraindications for PET/CT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| True positive rate per patient specimen | 24 months | The probability of GET is given when immunhistochemistry test is positive. |
| True positive rate per patient | 24 months | 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 | 24 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Ex-vivo PSMA expression | 24 months | Expression of PSMA per specimen at immunhistochemistry. |
| PSMA uptake on 18F-PSMA-1007 PET | 24 months | Quantified uptake of PSMA per tumor lesion basis. |
Countries
Germany
Contacts
Primary ContactAlexander M Weich, MD
Backup ContactRudolf A Werner, MD
Outcome results
None listed