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Trial Title:
PSMA in Gastrointestinal Tumors (GIPSMA, Focusing on Neuroendocrine Neoplasms)
NCT ID:
NCT05547919
Condition:
Gastrointestinal Cancer
Conditions: Official terms:
Neoplasms
Gastrointestinal Neoplasms
Neuroendocrine Tumors
Digestive System Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
18F-PSMA PET/CT
Description:
Patients with metastasized gastrointestinal tumors, that exhibit histological PSMA
expression, receive an additional 18F-PSMA PET/CT to routine imaging.
Arm group label:
Gastrointestinal tumors histologically positive for PSMA
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.
Gastrointestinal tumors (GIT), including gastroenteropancreatic neuroendocrine neoplasms
(GEP-NEN) 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 GEP-NEN 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with newly diagnosed GEP-NEN 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Wuerzburg
Address:
City:
Wuerzburg
Zip:
97080
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Alexander M Weich, MD
Phone:
+4993120140201
Email:
weich_a@ukw.de
Contact backup:
Last name:
Rudolf A Werner, MD
Phone:
+4993120135001
Email:
werner_r1@ukw.de
Start date:
October 1, 2022
Completion date:
October 1, 2026
Lead sponsor:
Agency:
Wuerzburg University Hospital
Agency class:
Other
Source:
Wuerzburg University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05547919
